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Maida M, Vitello A, Zullo A, Ramai D, Facciorusso A, Vassallo R. Gender Differences in Quality of Bowel Preparation for Colonoscopy: Post Hoc Analysis of a Randomized Controlled Trial. J Clin Gastroenterol 2025; 59:344-349. [PMID: 38847811 DOI: 10.1097/mcg.0000000000002024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/12/2024] [Accepted: 04/21/2024] [Indexed: 07/23/2024]
Abstract
OBJECTIVE Bowel cleansing is a key element for a quality colonoscopy. Despite recent advances, not all predictors of successful cleansing are fully known. This post hoc analysis of an RCT aims to explore gender differences in bowel cleansing quality. METHODS The "OVER" trial was a multicenter phase-4 RCT including 478 patients randomized 1:1 to receive split-dose 1L polyethylene glycol plus ascorbate (PEG+ASC) or 4L-PEG. In this post hoc analysis, multivariable logistic regression models were designed to assess predictors of cleansing success (CS) and adenoma detection rate (ADR) by gender. RESULTS Of the 478 randomized patients, 50.2% were males and 49.8% females.Overall, CS was comparable between females and males (87.1% vs 88.4, P = 0 .6), whereas CS in the right (95.7% vs 90.9, P = 0.049) and transverse colon (98.6% vs 93.9, P =0.011) was significantly higher in females.At multivariable regression analysis for CS outpatient setting (OR = 5.558) and higher withdrawal time (OR = 1.294) were independently associated with CS in females, whereas screening/surveillance indication (OR = 6.776) was independently associated with CS in males.At multivariable regression analysis for ADR, running time <5 hours (OR = 3.014) and higher withdrawal time (OR = 1.250) were independently associated with ADR in females, whereas older age (OR = 1.040) and higher withdrawal time (OR = 1.093) were independently associated with ADR in males. CONCLUSIONS This study showed different results in bowel preparation quality and different predictors of CS and ADR by gender. These findings suggest the need for further research to explore gender-specific approaches for bowel preparation.
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Affiliation(s)
- Marcello Maida
- Department of Medicine and Surgery, University of Enna 'Kore', Enna
- Gastroenterology Unit, Umberto I Hospital, Enna, Italy
| | | | - Angelo Zullo
- Gastroenterology Unit, Nuovo Regina Margherita Hospital, Roma
| | - Daryl Ramai
- Division of Gastroenterology, Hepatology, and Nutrition, University of Utah Health, Salt Lake City, UT
| | - Antonio Facciorusso
- Department of Medical Sciences, Gastroenterology Unit, University of Foggia, Foggia, Italy
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Machlab S, Lorenzo-Zúñiga V, Pantaleon MA, Sábado F, Arieira C, Pérez Arellano E, Cotter J, Carral D, Turbí Disla C, Gorjão R, Esteban JM, Rodriguez S. Real-world effectiveness and safety of 1L polyethylene glycol and ascorbic acid for bowel preparation in patients aged 80 years or older. Endosc Int Open 2025; 13:a25259938. [PMID: 40018074 PMCID: PMC11866040 DOI: 10.1055/a-2525-9938] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/26/2024] [Accepted: 01/15/2025] [Indexed: 03/01/2025] Open
Abstract
Background and study aims Clinical trials and real-world studies show a 1L polyethene glycol and ascorbic acid solution (1L PEG-ASC) to be an effective and safe bowel preparation for colonoscopy in the general population. Here, the effectiveness and safety of 1L PEG-ASC were evaluated in patients aged 80 years or older in a real-world setting. Patients and methods A post-hoc analysis of an observational, multicenter, retrospective study assessed the effectiveness and safety of 1L PEG-ASC on outpatients aged ≥ 80 years old undergoing colonoscopy at eight centers in Spain and Portugal. Cleansing quality was assessed using the Boston Bowel Preparation Scale, with overall scores ≥ 6 and all segmental scores ≥ 2 considered adequate colon cleansing, and overall scores ≥ 8 or 3 in the right colon considered high-quality cleansing. Cecal intubation rate, withdrawal time, polyp and adenoma detection rates (ADR), and adverse events (AEs) were also monitored. Results Data were analyzed from 423 patients aged ≥ 80 years; mean age 83.5 years (±3.2) and 49.2% males. The adequate colon cleansing success rate was 88.9%, with high-quality cleansing of the overall and right colon achieved in 54.1% and 46.1% of patients, respectively. Colonoscopy was complete in 94.1% of cases and the ADR was 51.3%. At least one AE was experienced by 4.5% of participants, the most frequent being mild dehydration (2.8%) and nausea (1.2%). Conclusions This post-hoc analysis confirms 1L PEG-ASC to be an effective and safe bowel cleansing preparation for patients aged 80 years or older in a real-world setting.
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Affiliation(s)
- Salvador Machlab
- Gastroenterology, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Sabadell, Spain
| | | | | | - Fernando Sábado
- Gastroenterology, Consorcio Hospitalario Provincial de Castelló, Castellón, Spain
| | - Cátia Arieira
- Gastroenterology, Hospital da Senhora da Oliveira, Guimarães, Portugal
| | | | - José Cotter
- Gastroenterology, Hospital da Senhora da Oliveira, Guimarães, Portugal
- School of Medicine, Universidade do Minho, Life and Health Sciences Research Institute (ICVS), Braga/Guimarães, Portugal
- Gastroenterology, ICVS/3B’s – PT Government Associate Laboratory, Braga/Guimarães, Portugal
| | - David Carral
- Gastroenterology, Hospital San Rafael, A Coruña, Spain
| | - Carmen Turbí Disla
- Medical Affairs, Norgine, Harefield, United Kingdom of Great Britain and Northern Ireland
| | - Ricardo Gorjão
- Gastroenterology, Hospital CUF Descobertas, Lisboa, Portugal
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Ramos JA, Carvalho D, Arantes VN. Novel regimen for colonoscopy bowel preparation with oral lactulose: a prospective comparative study. Clin Endosc 2024; 57:775-782. [PMID: 39434557 PMCID: PMC11637660 DOI: 10.5946/ce.2024.056] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/06/2024] [Revised: 05/28/2024] [Accepted: 06/03/2024] [Indexed: 10/23/2024] Open
Abstract
BACKGROUND/AIMS Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation; however, due to the necessity of a large volume, patient tolerance is impaired. Therefore, lactulose is a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy and safety of lactulose-based bowel preparations in comparison with PEG for colonoscopy. METHODS This is a prospective, non-blinded, comparative study. Outpatients were randomly divided into two groups: group 1 (111 patients), PEG; and group 2 (111 patients), lactulose. The following clinical outcomes were assessed in each group: degree of bowel clearance using the Boston bowel preparation score, colorectal polyp detection rate, adenoma detection rate, tolerability, and side effects. RESULTS The rate of inadequate bowel preparation was 8.1% and 1.8% for the PEG and lactulose groups, respectively (p=0.030). The Boston bowel preparation score for the entire colon was 7.34±1.17 and 8.36±1.09 for the PEG and lactulose groups, respectively (p<0.001). The satisfactory overall experience rates were 27.9% and 62.2% for the PEG and lactulose groups, respectively (p<0.001). CONCLUSIONS The novel bowel preparation with oral lactulose was superior to that with PEG in terms of colon cleansing, adenoma detection rate, tolerance, and patient experience.
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Affiliation(s)
- Josué Aliaga Ramos
- Department of Gastroenterology, Hospital “José Agurto Tello-Chosica”, Gastroenterology Service “Madre Zoraida” Clinic, Digestive Endoscopy Unit of San Pablo Clinic, Lima, Peru
| | - Danilo Carvalho
- Endoscopy Unit, Alfa Institute of Gastroenterology, Belo Horizonte, Brazil
| | - Vitor N. Arantes
- Endoscopy Unit, Alfa Institute of Gastroenterology, School of Medicine, Federal University of Minas Gerais, Hospital Mater Dei Contorno, Belo Horizonte, Brazil
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Lorenzo-Zúñiga García V, Sábado Martí F, Pantaleón Sánchez MÁ, Machlab Mashlab S, Carral Martínez D, Gómez Rodríguez BJ, López Cano A, Rodríguez Muñoz S, Pérez Arellano E, Turbi Disla C, Esteban López-Jamar JM. Effectiveness and safety of a 1-L polyethylene glycol and ascorbic acid preparation for colonoscopy in routine clinical practice in Spain. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2024; 116:599-605. [PMID: 39087668 DOI: 10.17235/reed.2024.10426/2024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 08/02/2024]
Abstract
BACKGROUND AND AIMS large clinical trials and small real-world studies show that a 1-L polyethylene glycol and ascorbic acid solution (1-L PEG-ASC) is an effective and safe bowel preparation for colonoscopy. Here, the effectiveness and safety of 1-L PEG-ASC was evaluated in a large cohort of patients in routine clinical practice in Spain. METHODS a sub-analysis was performed in an observational, multicenter, retrospective study assessing the effectiveness and safety of 1-L PEG-ASC in adult patients undergoing a colonoscopy at ten centers in Spain. Cleansing quality was assessed with the Boston Bowel Preparation Scale, scores ≥ 6 with all segmental scores ≥ 2 were considered as adequate colon cleansing, and high-quality was considered as cleansing ≥ 8 or = 3 in the right colon. Polyp and adenoma detection rates, and adverse events were also assessed. RESULTS data were collected from 7,160 patients; 48.3 % were males, mean age was 58.0 and 33.6 % were ≥ 65 years old. Adequate overall bowel cleansing was achieved in 95.6 % of patients (95 % CI: 95.1-96.0 %), high quality cleansing in 74.4 % (95 % CI: 73.4-75.4 %) and high-quality right colon cleansing in 66.0 % (95 % CI: 64.9-67.1). The adequate overall cleansing rate was 97.0 % with a split-dose and 94.0 % with same-day regimen (p < 0.0001), and high-quality right colon cleansing was 69.0 % and 62.5 % (p < 0.0001), respectively. Colonoscopy was completed in 97.2 % of cases. A multivariate regression analysis revealed that an overnight split-dose regimen and age < 65 years were independent predictors of adequate bowel cleansing of the overall colon, age < 65 years and female gender were independent predictors of high quality (HQ) cleansing of the overall colon, and the three covariates were independent predictors of HQ cleansing of the right colon. At least one adverse event was experienced by 3.3 % of participants, with nausea (1.5 %) and vomiting (1.2 %) being the most frequent. CONCLUSION this sub-analysis confirmed 1-L PEG-ASC to be an effective and safe bowel cleansing preparation in a real world setting in Spain.
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Maeda N, Higashimori A, Yamamoto I, Kin D, Morimoto K, Nakatani M, Sasaki E, Fukuda T, Arakawa T, Fujiwara Y. Bowel preparation with linaclotide and 1 L polyethylene glycol plus ascorbic acid prior to colonoscopy in chronic constipated patients. Scand J Gastroenterol 2024; 59:1209-1215. [PMID: 39219191 DOI: 10.1080/00365521.2024.2398094] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/26/2024] [Revised: 07/20/2024] [Accepted: 08/25/2024] [Indexed: 09/04/2024]
Abstract
BACKGROUND AND AIMS Information on effective bowel preparation (BP) methods for patients with constipation is limited. We recently reported the efficacy of 1 L polyethylene glycol plus ascorbic acid (PEG-Asc) combined with senna for BP; however, this regimen was insufficient in patients with constipation. We hypothesized that the addition of linaclotide, which is approved for the treatment of chronic constipation, to 1 L PEG-Asc would yield results superior to those of senna in patients with constipation. METHODS This was a retrospective, single-center study that included outpatients with constipation who underwent BP prior to colonoscopy between March and December 2019 (receiving 1 L PEG-Asc with 24 mg senna) and between January and October 2020 (receiving 1 L PEG-Asc with 500 mg linaclotide). RESULTS A total of 543 patients with constipation were included, of whom 269 received linaclotide and 274 received senna. The rate of inadequate BP was significantly lower (11% vs 20%, p < 0.01) and the adenoma detection rate was significantly higher (54% vs 45%, p = 0.04) in the linaclotide group than in the senna group. Multivariate analysis revealed that the linaclotide regimen significantly reduced the risk of inadequate BP (odds ratio = 0.36, 95% confidence interval = 0.21-0.60, p < 0.01). CONCLUSIONS The linaclotide regimen significantly increased BP efficacy and the adenoma detection rate compared with the senna regimen without reducing tolerability and is therefore a promising new option for BP in patients with constipation.
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Affiliation(s)
- Natsumi Maeda
- Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan
| | - Akira Higashimori
- Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan
| | - Ikki Yamamoto
- Department of Gastroenterology, Minami Osaka Hospital, Osaka, Japan
| | - Daiyu Kin
- Department of Gastroenterology, Minami Osaka Hospital, Osaka, Japan
| | - Kenichi Morimoto
- Department of Gastroenterology, Minami Osaka Hospital, Osaka, Japan
| | - Masami Nakatani
- Department of Gastroenterology, Minami Osaka Hospital, Osaka, Japan
| | - Eiji Sasaki
- Department of Gastroenterology, Minami Osaka Hospital, Osaka, Japan
| | - Takashi Fukuda
- Department of Gastroenterology, Minami Osaka Hospital, Osaka, Japan
| | - Tetsuo Arakawa
- Department of Gastroenterology, Minami Osaka Hospital, Osaka, Japan
| | - Yasuhiro Fujiwara
- Department of Gastroenterology, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan
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Liu WQ, Shu L, Zhou X, Wang XF, Liu S, Shi ZH. Evaluation of the efficacy of polyethylene glycol in combination with different doses of linaclotide in a fractionated bowel preparation for colonoscopy: a prospective randomized controlled study. Int J Colorectal Dis 2024; 39:143. [PMID: 39289199 PMCID: PMC11408392 DOI: 10.1007/s00384-024-04718-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 09/06/2024] [Indexed: 09/19/2024]
Abstract
BACKGROUND AND AIM The ideal bowel cleansing program still needs to be explored. The aim was to compare the bowel cleansing effect and patient tolerance of low-dose polyethylene glycol (PEG) combined with different doses of linaclotide in fractionated bowel preparation. METHODS The subjects were randomly assigned to the 3LPEG group, 2LPEG + 2L group, or 2LPEG + L group. The primary outcome was to use the Ottawa Bowel Preparation Scale (OBPS) to evaluate the efficacy of bowel cleansing, and the secondary outcomes were the detection rate of adenomas and polyps, adverse reactions, tolerance, and defecation dynamics; subsets of patients with chronic constipation and irritable bowel syndrome were also analyzed. RESULTS A total of 753 patients were randomly assigned. In ITT analysis, the success of preparation of the 2LPEG + 2L group was better than that of the 2LPEG + L group or the 3LPEG group (92.0% vs. 82.3% vs. 82.1%; P = 0.002). Compared with the 3LPEG group, the 2LPEG + L group showed similar but non-inferior results (82.3% vs. 82.1%, P > 0.05). The 2LPEG + 2L group was similar to the 2LPEG + L group in terms of adverse reaction, tolerance, willingness to reuse, and sleep quality, but both were superior to the 3LPEG group. In a subgroup analysis of chronic constipation, the 2LPEG + 2L group had the best cleansing effect on the right colon and mid colon, while in the subgroup analysis of irritable bowel syndrome, the tolerance was better in the 2LPEG + 2L group and the 2LPEG + L group than the 3LPEG group. CONCLUSIONS 2LPEG + 2L is a feasible bowel preparation regimen.
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Affiliation(s)
- Wan-Qi Liu
- Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Chinese Medicine, Shanghai, 200032, China
| | - Lei Shu
- Department of Gastroenterology, Wuhan No.1 Hospital, Wuhan, 430022, Hubei Province, China
| | - Xiaoli Zhou
- Department of Gastroenterology, Wuhan No.1 Hospital, Wuhan, 430022, Hubei Province, China
| | - Xiao-Feng Wang
- Ezhou Traditional Chinese Medicine Hospital, Ezhou, 436001, Hubei Province, China
| | - Song Liu
- Department of Gastroenterology, Wuhan No.1 Hospital, Wuhan, 430022, Hubei Province, China.
| | - Zhao-Hong Shi
- Department of Gastroenterology, Wuhan No.1 Hospital, Wuhan, 430022, Hubei Province, China.
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Zhao HY, Cai XF, Chen PP, Wang XB, Liu CX, Chen D, Xu J. Efficacy of linaclotide in combination with polyethylene glycol for bowel preparation in Chinese patients undergoing colonoscopy polypectomy: protocol for a randomised controlled trial. BMJ Open 2024; 14:e080723. [PMID: 39043596 PMCID: PMC11733793 DOI: 10.1136/bmjopen-2023-080723] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2023] [Accepted: 06/19/2024] [Indexed: 07/25/2024] Open
Abstract
BACKGROUND Adequate bowel preparation is essential for successful colonoscopy and polypectomy procedures. However, a significant proportion of patients still exhibit suboptimal bowel preparation, ranging from 18% to 35%. The effectiveness of bowel preparation agents can be hampered by volume and taste, adversely affecting patient compliance and tolerance. Therefore, exploring strategies to minimise laxative volume and improve patient tolerance and adherence is imperative to ensure optimal bowel preparation quality. METHODS AND ANALYSIS This study is a two-arm, single-blinded, parallel-group randomised controlled trial designed to compare the efficacy of 2 L polyethylene glycol (PEG) combined with linaclotide with 4 L PEG in bowel cleansing. A total of 422 participants will be randomly assigned in a 1:1 ratio to either the intervention group (2 L PEG combined with 580 µg linaclotide) or the control group (4 L PEG). The primary outcome measure is bowel cleansing efficacy, which is assessed using the Boston Bowel Preparation Scale. Secondary outcomes include evaluating the tolerability and safety of the bowel preparation regimens, bowel diary assessments, postpolypectomy complications (such as bleeding and perforation) and the size and number of removed polyps. ETHICS AND DISSEMINATION The study has received approval from the Clinical Research Ethics Committee of The First Affiliated Hospital, Zhejiang University School of Medicine. The findings of this trial will serve as a valuable resource for clinicians and patients undergoing colonoscopy polypectomy by guiding the selection of appropriate bowel preparation regimens. Study findings will be disseminated to participants, presented at professional society meetings, and published in peer-reviewed journals. This trial was registered on the Chinese Clinical Trial Registry with registration number ChiCTR2300075410.
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Affiliation(s)
- Hui-Ying Zhao
- Department of Nursing, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Xiao-Feng Cai
- Department of Nursing, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Ping-Ping Chen
- Department of Nursing, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Xiao-Bin Wang
- Department of Nursing, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Chao-Xu Liu
- Department of Colorectal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Dong Chen
- Department of Colorectal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Jing Xu
- Department of Nursing, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
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Sinagra E, Mandarino FV, Maida M, Cabibi D, Rossi F, Raimondo D, Manfredi G. Focal Active Colitis: What Are Its Clinical Implications? A Narrative Review. Biomedicines 2023; 11:2631. [PMID: 37893005 PMCID: PMC10604212 DOI: 10.3390/biomedicines11102631] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/11/2023] [Revised: 09/15/2023] [Accepted: 09/18/2023] [Indexed: 10/29/2023] Open
Abstract
Focal active colitis (FAC) is described as a histolopathological term indicating the isolated finding of focal neutrophil infiltration in the colonic crypts. Currently, there exist numerous debates regarding the clinical significance of diagnosing FAC, which may or may not have clinical relevance as it is frequently detected in colorectal biopsies without any other microscopic abnormalities. The objective of this narrative review is to provide an overview of the available evidence concerning the clinical implications of FAC, both in the adult population (among five studies available in the scientific literature) and in the pediatric context (based on two available studies).
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Affiliation(s)
- Emanuele Sinagra
- Gastroenterology and Endoscopy Unit, Fondazione Istituto G. Giglio, Contrada Pietra Pollastra Pisciotto, 90015 Cefalù, Italy; (F.R.); (D.R.)
| | - Francesco Vito Mandarino
- Division of Gastroenterology and Gastrointestinal Endoscopy, Department of Experimental Oncology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, 20132 Milan, Italy;
| | - Marcello Maida
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, 93100 Caltanissetta, Italy;
| | - Daniela Cabibi
- Pathology Unit, Fondazione Istituto G. Giglio, Contrada Pietra Pollastra Pisciotto, 90015 Cefalù, Italy;
| | - Francesca Rossi
- Gastroenterology and Endoscopy Unit, Fondazione Istituto G. Giglio, Contrada Pietra Pollastra Pisciotto, 90015 Cefalù, Italy; (F.R.); (D.R.)
| | - Dario Raimondo
- Gastroenterology and Endoscopy Unit, Fondazione Istituto G. Giglio, Contrada Pietra Pollastra Pisciotto, 90015 Cefalù, Italy; (F.R.); (D.R.)
| | - Guido Manfredi
- Gastroenterology and Digestive Endoscopy Department, ASST-Crema Maggiore Hospital, 26013 Crema, Italy;
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Maida M, Ventimiglia M, Facciorusso A, Vitello A, Sinagra E, Marasco G. Effectiveness and safety of 1-L PEG-ASC versus other bowel preparations for colonoscopy: A meta-analysis of nine randomized clinical trials. Dig Liver Dis 2023; 55:1010-1018. [PMID: 36470722 DOI: 10.1016/j.dld.2022.11.010] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/31/2022] [Revised: 10/30/2022] [Accepted: 11/08/2022] [Indexed: 12/04/2022]
Abstract
BACKGROUND AND AIMS A 1-L polyethylene glycol plus ascorbate (PEG-ASC) preparation has been recently developed to improve patients' experience in colonoscopy. This meta-analysis aimed to evaluate the effectiveness and safety of 1-L PEG-ASC compared with those of other bowel preparations for colonoscopy. METHODS MEDLINE, Embase, Scopus, and the Cochrane Library were systematically searched for randomized controlled trials comparing 1-L PEG-ASC with other bowel preparations published through July 2022. A random-effects model was applied for pooling the results; heterogeneity was expressed as I2. RESULTS Nine studies met the inclusion criteria and were included. The analysis showed significantly higher cleansing success (CS) (OR = 1.50; 95% CI = 1.25-1.81; p < 0.01, I2 = 0%) and right-colon high-quality cleansing (HQC) (OR = 1.67; 95% CI = 1.21-2.31; p < 0.01, I2 = 43%) with 1-L PEG-ASC compared to the other preparations. The pooled estimate of the adenoma detection rate (ADR) did not significantly differ between the two groups either in the overall (OR = 1.02; 95% CI = 0.87-1.20; p = 0.79, I2 = 0%) or split-dosing regimen subgroup analysis (OR = 0.99; 95% CI = 0.84-1.18; p = 0.94, I2 = 0%). A significantly higher pooled estimate of the number of patients with adverse events (AEs) (OR = 1.51; 95% CI = 1.23-1.84; p<0.01, I2 = 0%) and incidence of AEs (IRR=1.33; 95% CI = 1.11-1.58; p<0.01, I2 = 71%) was observed with 1-L PEG-ASC than with the other preparations. No serious AEs or deaths occurred. CONCLUSIONS Compared to other preparations, 1-L PEG-ASC yielded higher overall CS, higher right-colon HQC rates, and similar ADR. The number of patients with AEs and incidence of the total AEs were significantly higher with 1-L PEG-ASC in the absence of serious AEs.
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Affiliation(s)
- M Maida
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy.
| | - M Ventimiglia
- Directorate General of Medical Device and Pharmaceutical Service, Italian Ministry of Health, Rome, Italy
| | - A Facciorusso
- Gastroenterology Unit, Department of Medical Sciences, University of Foggia, Foggia, Italy
| | - A Vitello
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy
| | - E Sinagra
- Gastroenterology and Endoscopy Unit, Fondazione Instituto San Raffaele Giglio, Cefalù, Italy
| | - G Marasco
- IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy; Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
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López-Jamar JME, Gorjão R, Cotter J, Lorenzo-Zúñiga García V, Pantaleón Sánchez MA, Carral Martínez D, Sábado F, Pérez Arellano E, Gómez Rodríguez BJ, López Cano A, Machlab S, Arieira C, Akriche F, Turbí Disla C, Rodriguez Muñoz S. Bowel cleansing effectiveness and safety of 1L PEG + Asc in the real-world setting: Observational, retrospective, multicenter study of over 13000 patients. Endosc Int Open 2023; 11:E785-E793. [PMID: 37593156 PMCID: PMC10431968 DOI: 10.1055/a-2125-0025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/11/2023] [Accepted: 06/23/2023] [Indexed: 08/19/2023] Open
Abstract
Background and study aims Effective bowel cleansing is critical for detecting lesions during colonoscopy, highlighting the importance of bowel preparations. 1L polyethylene glycol (PEG) + ascorbate (Asc) is the only recommended 1L PEG product in Europe and the United States. Its efficacy was demonstrated in large-scale controlled trials and confirmed in smaller-scale real-world studies. However, no large-scale real-world data exist. Patients and methods This observational, retrospective, multicenter study, used outpatient follow-up data from medical records from 10 centers in Spain and two in Portugal. Outpatients aged ≥18 years using 1L PEG + Asc as bowel preparation were included. The main outcome measures were overall adequate colon cleansing (Boston Bowel Preparation Scale [BBPS] score ≥6 with BBPS score ≥2 in each segment) and high-quality cleansing of the right colon (BBPS score=3). Results Data from 13169 eligible patients were included. Overall cleansing success was achieved in 89.3% (95%CI 88.7%-89.8%) and high-quality cleansing in the right colon in 49.3% (95%CI 48.4%-50.2%) of patients. For the overnight split-dose and same-day regimens, overall adequate quality cleansing success rate was 94.7% and 86.7% ( P <0.0001) and high-quality cleansing of the right colon rate was 65.4% and 41.4% ( P <0.0001), respectively. Colonoscopy was completed in 97.3% of patients, with non-completion due to poor preparation in only 0.8%; 2.3% of patients experienced at least one adverse event (AE). Conclusions This large-scale, real-world study demonstrates the effectiveness of 1L PEG + Asc in the total and right colon, with a low percentage of patients with AEs in routine clinical practice.
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Affiliation(s)
| | - Ricardo Gorjão
- Gastroenterology, Hospital CUF Descobertas, Lisboa, Portugal
| | - José Cotter
- Gastroenterology, Hospital da Senhora da Oliveira, Guimarães, Portugal
- Life and Health Sciences Research Institute (ICVS), School of Medicine, Universidade do Minho, Braga/Guimarães, Portugal
- Gastroenterology, ICVS/3B’s—PT Government Associate Laboratory, Braga/Guimarães, Portugal
| | | | | | | | - Fernando Sábado
- Gastroenteroloy, Consorcio Hospitalario Provincial de Castelló, Castellón, Spain
| | | | | | | | - Salvador Machlab
- Gastroenterology, Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Sabadell, Spain
| | - Cátia Arieira
- Gastroenterology, Hospital da Senhora da Oliveira, Guimarães, Portugal
| | - Fatma Akriche
- Medical Affairs, Norgine, Harefield, United Kingdom of Great Britain and Northern Ireland
| | - Carmen Turbí Disla
- Medical Affairs, Norgine, Harefield, United Kingdom of Great Britain and Northern Ireland
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Au M, Low P, Rennie M, Mohseni M, Song Y, Kim N, Baraty B, Mitrev N, He E, Ho V, Leong R, Kariyawasam V. Determining efficacy of dynamic multimedia bowel preparation instructions versus standard instructions on adenoma detection and patient reported measures (DIGICLEAN trial): a study protocol for a multicentre, colonoscopist-blinded, randomised controlled trial. BMJ Open 2023; 13:e073843. [PMID: 37479508 PMCID: PMC10364173 DOI: 10.1136/bmjopen-2023-073843] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 07/23/2023] Open
Abstract
INTRODUCTION Colonoscopy plays important roles in bowel cancer screening and treatment. Poor bowel preparation occurs in 20-25% of colonoscopies. This negatively impacts adenoma and sessile serrated lesion detection rates, procedural time, requirement for repeat colonoscopies, healthcare costs and likelihood of patient withdrawal from screening programmes. It is unclear whether a combination of multimedia modalities can improve bowel preparation quality, adenoma detection rates and patient-reported measures in those undergoing colonoscopy assessment. METHODS The DIGICLEAN trial is a prospective, parallel, multicentre, colonoscopist-blinded, randomised controlled trial. The trial will enrol 1294 participants aged 45 years and older who are indicated for a colonoscopy as an outpatient with a positive faecal occult blood test, iron deficiency anaemia or rectal bleeding. Participants will be randomised into the interventional arm, where bowel preparation instructions are delivered via a web-based application which uses scheduled short messaging service, regular patient survey assessment, email and videos; or the control arm, where routine standard written, verbal or emailed instructions are administered. The web-based application will assess patient-reported bloating, constipation and dietary adherence leading up to the colonoscopy. Depending on patient responses, additional aperients may be encouraged digitally in the interventional arm with same instructions made available in written format for the control arm. Patient-reported measures will be collected in both arms the day after the procedure using the validated Newcastle ENDOPREM questionnaire. In some sites, participants will undergo digital pre-anaesthetic screening as well. The co-primary endpoints are the adenoma detection rates and patient-reported measures taken after the colonoscopy. ETHICS AND DISSEMINATION Ethics approval for this study was obtained from the Western Sydney Local Health District Human Research Ethics Committee (2022/ETH00059). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER ACTRN12622000747729.
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Affiliation(s)
- Michael Au
- Department of Gastroenterology and Hepatology, Western Sydney Local Health District, Blacktown, New South Wales, Australia
- School of Medicine, Western Sydney University, Blacktown, New South Wales, Australia
| | - Patrick Low
- School of Medicine, Western Sydney University, Blacktown, New South Wales, Australia
| | - Michael Rennie
- Department of Gastroenterology and Hepatology, Western Sydney Local Health District, Blacktown, New South Wales, Australia
| | - Marriam Mohseni
- Department of Gastroenterology and Hepatology, Western Sydney Local Health District, Blacktown, New South Wales, Australia
| | - Yang Song
- Clinical Research Support Unit, Research and Education Network, Western Sydney Local Health District, Westmead, New South Wales, Australia
| | - Narae Kim
- Clinical Research Support Unit, Research and Education Network, Western Sydney Local Health District, Westmead, New South Wales, Australia
| | - Brandon Baraty
- Department of Gastroenterology and Hepatology, Western Sydney Local Health District, Blacktown, New South Wales, Australia
| | - Nikola Mitrev
- Department of Gastroenterology and Hepatology, Western Sydney Local Health District, Blacktown, New South Wales, Australia
| | - Emily He
- Department of Gastroenterology and Hepatology, Sydney Local Health District, Concord, New South Wales, Australia
- The Daffodil Centre, Cancer Council NSW, Woolloomooloo, New South Wales, Australia
| | - Vincent Ho
- School of Medicine, Western Sydney University, Penrith South, New South Wales, Australia
- Department of Gastroenterology and Hepatology, Campbelltown Hospital, Campbelltown, New South Wales, Australia
| | - Rupert Leong
- Department of Gastroenterology and Hepatology, Sydney Local Health District, Concord, New South Wales, Australia
- School of Medicine, The University of Sydney, Sydney, New South Wales, Australia
| | - Viraj Kariyawasam
- Department of Gastroenterology and Hepatology, Western Sydney Local Health District, Blacktown, New South Wales, Australia
- School of Medicine, Western Sydney University, Blacktown, New South Wales, Australia
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12
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Maida M, Marasco G, Facciorusso A, Shahini E, Sinagra E, Pallio S, Ramai D, Murino A. Effectiveness and application of artificial intelligence for endoscopic screening of colorectal cancer: the future is now. Expert Rev Anticancer Ther 2023; 23:719-729. [PMID: 37194308 DOI: 10.1080/14737140.2023.2215436] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2022] [Accepted: 05/15/2023] [Indexed: 05/18/2023]
Abstract
INTRODUCTION Artificial intelligence (AI) in gastrointestinal endoscopy includes systems designed to interpret medical images and increase sensitivity during examination. This may be a promising solution to human biases and may provide support during diagnostic endoscopy. AREAS COVERED This review aims to summarize and evaluate data supporting AI technologies in lower endoscopy, addressing their effectiveness, limitations, and future perspectives. EXPERT OPINION Computer-aided detection (CADe) systems have been studied with promising results, allowing for an increase in adenoma detection rate (ADR), adenoma per colonoscopy (APC), and a reduction in adenoma miss rate (AMR). This may lead to an increase in the sensitivity of endoscopic examinations and a reduction in the risk of interval-colorectal cancer. In addition, computer-aided characterization (CADx) has also been implemented, aiming to distinguish adenomatous and non-adenomatous lesions through real-time assessment using advanced endoscopic imaging techniques. Moreover, computer-aided quality (CADq) systems have been developed with the aim of standardizing quality measures in colonoscopy (e.g. withdrawal time and adequacy of bowel cleansing) both to improve the quality of examinations and set a reference standard for randomized controlled trials.
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Affiliation(s)
- Marcello Maida
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy
| | - Giovanni Marasco
- IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy
- Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy
| | - Antonio Facciorusso
- Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy
| | - Endrit Shahini
- Gastroenterology Unit, National Institute of Gastroenterology-IRCCS "Saverio de Bellis", Castellana Grotte, Bari, Italy
| | - Emanuele Sinagra
- Gastroenterology and Endoscopy Unit, Fondazione Istituto San Raffaele Giglio, Cefalu, Italy
| | - Socrate Pallio
- Digestive Diseases Endoscopy Unit, Policlinico G. Martino Hospital, University of Messina, Messina, Italy
| | - Daryl Ramai
- Gastroenterology & Hepatology, University of Utah Health, Salt Lake City, UT, USA
| | - Alberto Murino
- Royal Free Unit for Endoscopy, The Royal Free Hospital and University College London Institute for Liver and Digestive Health, Hampstead, London, UK
- Department of Gastroenterology, Cleveland Clinic London, London, UK
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13
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Maione F, Manigrasso M, Milone M, Gennarelli N, Maione R, Cantore G, Chini A, De Palma GD. Could atmospheric temperature impact on adequate colon cleansing for colonoscopy? An observational, single-institution study. Int J Colorectal Dis 2023; 38:96. [PMID: 37055678 PMCID: PMC10102074 DOI: 10.1007/s00384-023-04393-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 04/03/2023] [Indexed: 04/15/2023]
Abstract
PURPOSE Several risk factors affecting the adequacy of colon cleansing have been proposed during the last decades. However, less is known about the impact that atmospheric aspects could have on adequacy of the bowel cleansing. The study aimed to investigate if the atmospheric temperature could impact on the bowel cleansing during colonoscopy. METHODS A prospective maintained database of the colonoscopies performed since 1st August 2017 to 31st March 2020 was retrospective reviewed. The primary outcome of the study was to identify if the atmospheric temperature was associated with inadequate colon cleansing during colonoscopy. Secondary outcome was to identify the other factors associated with an inadequate colon cleansing. RESULTS One thousand two hundred twenty patients were enrolled. High atmospheric temperature (> 25 °C) significantly influenced the colon cleansing (p < 0.0001). Adequate colon cleansing was negatively influenced by gender (female patients were associated with higher colon cleansing rate, p = 0.013), diabetes (p < 0.0001), previous pelvic surgery (p = 0.001), use of Beta-Blocker (p = 0.001), anti-platelet (p = 0.017), angiotensin converting enzyme inhibitors (p = 0.001), the adoption of 4 L Poly Ethylene Glycol solution (p = 0.009), single-dose regimen (p < 0.0001) low patients' compliance (p < 0.0001), higher age and body mass index (p < 0.0001 and p = 0.025), lower education levels (p < 0.0001). On the contrary, admission to the ward to perform bowel preparation positively impacted on colon cleansing (p = 0.002). CONCLUSION Atmospheric temperature could play an important role in the colon cleansing during colonoscopy, being high temperature (> 25 °C) associated with lower rate of adequate bowel cleansing. However, being this relationship never studied before, these results must be confirmed by other studies.
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Affiliation(s)
- Francesco Maione
- Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Via Pansini 5, 80131, Naples, Italy
| | - Michele Manigrasso
- Department of Advanced Biomedical Sciences, "Federico II" University of Naples, Via Pansini 5, 80131, Naples, Italy
| | - Marco Milone
- Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Via Pansini 5, 80131, Naples, Italy
| | - Nicola Gennarelli
- Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Via Pansini 5, 80131, Naples, Italy
| | - Rosa Maione
- Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Via Pansini 5, 80131, Naples, Italy
| | - Grazia Cantore
- Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Via Pansini 5, 80131, Naples, Italy
| | - Alessia Chini
- Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Via Pansini 5, 80131, Naples, Italy.
| | - Giovanni Domenico De Palma
- Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Via Pansini 5, 80131, Naples, Italy
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Shahini E, Sinagra E, Vitello A, Ranaldo R, Contaldo A, Facciorusso A, Maida M. Factors affecting the quality of bowel preparation for colonoscopy in hard-to-prepare patients: Evidence from the literature. World J Gastroenterol 2023; 29:1685-1707. [PMID: 37077514 PMCID: PMC10107216 DOI: 10.3748/wjg.v29.i11.1685] [Citation(s) in RCA: 22] [Impact Index Per Article: 11.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/01/2022] [Revised: 02/02/2023] [Accepted: 03/07/2023] [Indexed: 03/17/2023] Open
Abstract
Adequate bowel cleansing is critical for a high-quality colonoscopy because it affects diagnostic accuracy and adenoma detection. Nevertheless, almost a quarter of procedures are still carried out with suboptimal preparation, resulting in longer procedure times, higher risk of complications, and higher likelihood of missing lesions. Current guidelines recommend high-volume or low-volume polyethylene glycol (PEG)/non-PEG-based split-dose regimens. In patients who have had insufficient bowel cleansing, the colonoscopy should be repeated the same day or the next day with additional bowel cleansing as a salvage option. A strategy that includes a prolonged low-fiber diet, a split preparation regimen, and a colonoscopy within 5 h of the end of preparation may increase cleansing success rates in the elderly. Furthermore, even though no specific product is specifically recommended in the other cases for difficult-to-prepare patients, clinical evidence suggests that 1-L PEG plus ascorbic acid preparation are associated with higher cleansing success in hospitalized and inflammatory bowel disease patients. Patients with severe renal insufficiency (creatinine clearance < 30 mL/min) should be prepared with isotonic high volume PEG solutions. Few data on cirrhotic patients are currently available, and no trials have been conducted in this population. An accurate characterization of procedural and patient variables may lead to a more personalized approach to bowel preparation, especially in patients undergoing resection of left colon lesions, where intestinal preparation has a poor outcome. The purpose of this review was to summarize the evidence on the risk factors influencing the quality of bowel cleansing in difficult-to-prepare patients, as well as strategies to improve colonoscopy preparation in these patients.
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Affiliation(s)
- Endrit Shahini
- Gastroenterology Unit, National Institute of Gastroenterology-IRCCS “Saverio de Bellis”, Castellana Grotte, Bari 70013, Italy
| | - Emanuele Sinagra
- Gastroenterology and Endoscopy Unit, Fondazione Istituto G. Giglio, Cefalù 90015, Italy
| | - Alessandro Vitello
- Gastroenterology and Endoscopy Unit, S.Elia-Raimondi Hospital, Caltanissetta 93100, Italy
| | - Rocco Ranaldo
- Department of Internal Medicine, “Mazzolani-Vandini” Hospital, Digestive Endoscopy, Ferrara 744011, Italy
| | - Antonella Contaldo
- Gastroenterology Unit, National Institute of Gastroenterology “S de Bellis” Research Hospital, Bari 70013, Italy
| | - Antonio Facciorusso
- Department of Medical Sciences, University of Foggia, Section of Gastroenterology, Foggia 71122, Italy
| | - Marcello Maida
- Gastroenterology and Endoscopy Unit, S.Elia-Raimondi Hospital, Caltanissetta 93100, Italy
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15
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Testoni PA, Notaristefano C, Soncini M, Hassan C, Monica F, Radaelli F, Triossi O, Pasquale L, Neri M, Cannizzaro R, Leandro G. An Italian prospective multicenter study on colonoscopy practice and quality: What has changed in the last 10 years. Dig Liver Dis 2023; 55:99-106. [PMID: 36266206 DOI: 10.1016/j.dld.2022.09.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/22/2022] [Revised: 09/15/2022] [Accepted: 09/15/2022] [Indexed: 11/05/2022]
Abstract
BACKGROUND A relevant number of adenomas can be missed during colonoscopy. AIMS Assess the current status of colonoscopy procedures in Italian centers. METHODS A prospective observational study involving 17 hospitals (34 endoscopists) included consecutive patients undergoing standard colonoscopy. In the first phase, endoscopists performed consecutive colonoscopies. In the second phase, retraining via an online learning platform was planned, while in the third phase data were collected analogously to phase 1. RESULTS A total of 3,504 patients were enrolled. Overall, a BBPS score ≥6 was obtained in 95.6% of cases (94.8% and 96.9% in the pre- and post-training phases, respectively). 88.4% of colonoscopies had a withdrawal time ≥6 min (88.2% and 88.7% in the pre- and post-training phases). Median adenoma detection rate (ADR) was 39.1%, with no significant differences between the pre- and post-training phases (40.1% vs 36.9%; P = 0.83). In total, 81% of endoscopists had a ADR performance above the 25% threshold. CONCLUSION High colonoscopy quality standards are achieved by the Italian hospitals involved. Quality improvement initiatives and repeated module-based colonoscopy-training have been promoted in Italy during the last decade, which appear to have had a significant impact on quality colonoscopy metrics together with the activation of colorectal cancer screening programs.
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Affiliation(s)
- Pier Alberto Testoni
- Division of Gastroenterology and G.I. Endoscopy, Vita Salute San Raffaele University, San Raffaele Scientific Institute, Milan, Italy.
| | - Chiara Notaristefano
- Division of Gastroenterology and G.I. Endoscopy, Vita Salute San Raffaele University, San Raffaele Scientific Institute, Milan, Italy
| | - Marco Soncini
- Department of Internal Medicine, A. Manzoni Hospital, ASST Lecco, Italy
| | - Cesare Hassan
- Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, 20089 Milan, Italy
| | - Fabio Monica
- Gastroenterology and Digestive Endoscopy, Cattinara Academic Hospital, Trieste, Italy
| | | | - Omero Triossi
- Gastroenterology Unit, Local Health Authority, Santa Maria delle Croci Hospital, Ravenna, Italy
| | - Luigi Pasquale
- Gastroenterology Unit, S. O. Frangipane Hospital of A. Irpino, Italy
| | - Matteo Neri
- Department of Medicine and Ageing Sciences, 'G. d'Annunzio' University of Chieti-Pescara, Chieti, Italy
| | - Renato Cannizzaro
- Oncological Gastroenterology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, 33081 Aviano, Italy
| | - Gioacchino Leandro
- National Institute of Gastroenterology "S. De Bellis" Research Hospital, Castellana Grotte, Italy
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The Effectiveness of a Very Low-Volume Compared to High-Volume Laxative in Colon Capsule Endoscopy. Diagnostics (Basel) 2022; 13:diagnostics13010018. [PMID: 36611310 PMCID: PMC9818960 DOI: 10.3390/diagnostics13010018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2022] [Revised: 12/16/2022] [Accepted: 12/19/2022] [Indexed: 12/24/2022] Open
Abstract
Colon capsule endoscopy (CCE) is a promising modality for colonic investigations, but completion rates (CR) and adequate cleansing rates (ACR) must be improved to meet established standards for optical colonoscopy. Improvements should be made with patient acceptability in mind. We aimed to compare a very low-volume polyethylene glycol (PEG) laxative to a conventional high-volume laxative. We carried out a single-center retrospective comparative cohort study including patients referred for CCE. One hundred and sixty-six patients were included in the final analysis, with eighty-three patients in each group. We found a CR and ACR of 77% and 67% in the high-volume group and 72% and 75% in the very low-volume group, respectively. In the high-volume group, 54% had complete transit and adequate cleansing, whereas this was the case for 63% in the very low-volume group. No statistically significant difference in CR, ACR, or a combination of the two was found. A very low-volume bowel preparation regimen was non-inferior to a high-volume regimen before CCE in terms of CR and ACR.
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Maida M, Facciorusso A, Sinagra E, Morreale G, Sferrazza S, Scalisi G, Pallio S, Camilleri S. Predictive Factors of Adequate Bowel Cleansing for Colonoscopy in the Elderly: A Retrospective Analysis of a Prospective Cohort. Diagnostics (Basel) 2022; 12:diagnostics12112867. [PMID: 36428927 PMCID: PMC9689943 DOI: 10.3390/diagnostics12112867] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/19/2022] [Revised: 11/13/2022] [Accepted: 11/15/2022] [Indexed: 11/22/2022] Open
Abstract
Factors affecting the quality of bowel preparation for colonoscopy in the elderly are not fully known, and current guidelines provide no specific recommendations. This study aimed to assess the difference in bowel cleansing in young and elderly patients and evaluate predictors of bowel cleansing in the elderly. We retrospectively reviewed a prospective cohort of 1289 patients performing colonoscopy after a 1-, 2-, or 4-L PEG-based preparation. All 1289 were included in the analysis. Overall, 44.6% of patients were aged ≥65 years. Cleansing success (CS) was achieved in 77.3% and 70.3% of patients aged <65 years and ≥65 years, respectively. At multivariable analysis, split regimen (OR = 2.43, 95% CI = 1.34−4.38; p = 0.003), adequate cleansing at previous colonoscopy (OR = 2.29, 95% CI = 1.14−4.73; p = 0.02), tolerability score (OR = 1.29, 95% CI = 1.16−1.44; p < 0.001), a low-fiber diet for at least 3 days (OR = 2.45, 95% CI = 1.42−4.24; p = 0.001), and colonoscopy within 5 h after the end of preparation (OR = 2.67, 95% CI = 1.28−5.56; p = 0.008) were independently associated with CS in the elderly. Combining a low-fiber diet for at least 3 days, split preparation, and colonoscopy within 5 h allowed a CS rate above 90% and should always be encouraged. A 1-L PEG-ASC preparation was also associated with greater high-quality cleansing of the right colon and may be preferred.
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Affiliation(s)
- Marcello Maida
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, 93100 Caltanissetta, Italy
- Correspondence: ; Tel.: +39-0934512247; Fax: +39-0934512323
| | - Antonio Facciorusso
- Department of Medical and Surgical Sciences, University of Foggia, 71100 Foggia, Italy
| | - Emanuele Sinagra
- Gastroenterology and Endoscopy Unit, Fondazione Istituto San Raffaele Giglio, 90015 Cefalù, Italy
| | - Gaetano Morreale
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, 93100 Caltanissetta, Italy
| | - Sandro Sferrazza
- Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, 38100 Trento, Italy
| | | | - Socrate Pallio
- Digestive Diseases Endoscopy Unit, Policlinico G. Martino Hospital, University of Messina, 98100 Messina, Italy
| | - Salvatore Camilleri
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, 93100 Caltanissetta, Italy
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Manno M, Biancheri P, Bonura GF, Gabbani T, Rainer J, Curatolo A, Deiana S, Impellizzeri G, Ottaviani L, Hassan C, Repici A, Soriani P. Safety of a novel 1L-polyethylene glycol-ascorbate solution for colonoscopy cleansing (REAL Study). Dig Liver Dis 2022; 54:1508-1512. [PMID: 35614002 DOI: 10.1016/j.dld.2022.04.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/27/2021] [Revised: 04/20/2022] [Accepted: 04/21/2022] [Indexed: 12/30/2022]
Abstract
BACKGROUND AND AIM Very low-volume bowel preparation (BP) for colonoscopy with 1-liter polyethylene glycol plus ascorbate (1L-PEG-Asc) has displayed high tolerability and quality of bowel cleansing. Concerns have been raised regarding its safety. We aimed to evaluate the incidence of adverse events (AEs) following BP with 1L-PEG-Asc or 2L-PEG-Asc. PATIENTS AND METHODS From January 2019 to September 2020, data from all consecutive adult outpatients who underwent colonoscopy in Our Unit were collected. AEs were assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of Modena District Hospitals in the 7 days following the colonoscopy, and were classified as "BP-related" or "BP-unrelated". RESULTS During the study, 4069 (68.03%) and 1912 (31.97%) patients underwent colonoscopy after taking 2L-PEG-Asc or 1L-PEG-Asc, respectively. Regarding AEs, 77 (1.29%) patients attended ED, 53 (53/4069, 1.30%) and 24 (24/1912, 1.25%) after taking 2L-PEG-Asc and 1L-PEG-Asc. BP-related AEs were observed in 5 (5/4069, 0.12%) and 4 (4/1912, 0.21%) patients, respectively. The most frequent BP-related AEs were tachyarrhythmias (6/5981, 0.10%). CONCLUSION The incidence rate of clinically relevant BP-related AEs is extremely low. This strongly suggests that 1L-PEG-Asc colonoscopy BP is as safe as 2L-PEG-Asc BP in a real-life clinical setting of unselected patients.
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Affiliation(s)
- Mauro Manno
- Gastroenterology and Digestive Endoscopy Unit, AUSL Modena, Italy
| | - Paolo Biancheri
- Gastroenterology and Digestive Endoscopy Unit, AUSL Modena, Italy
| | | | - Tommaso Gabbani
- Gastroenterology and Digestive Endoscopy Unit, AUSL Modena, Italy
| | - Joachim Rainer
- Gastroenterology and Digestive Endoscopy Unit, AUSL Modena, Italy
| | - Angela Curatolo
- Gastroenterology and Digestive Endoscopy Unit, AUSL Modena, Italy
| | - Simona Deiana
- Gastroenterology and Digestive Endoscopy Unit, AUSL Modena, Italy
| | | | - Laura Ottaviani
- Gastroenterology and Digestive Endoscopy Unit, AUSL Modena, Italy
| | - Cesare Hassan
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
| | - Alessandro Repici
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
| | - Paola Soriani
- Gastroenterology and Digestive Endoscopy Unit, AUSL Modena, Italy.
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Choi SH, Yoon WE, Kim SH, Myung HJ, Kim SH, So SO, Kim SH, Lee HM, Oh YJ, Moon JS, Park TY, Kim YS. Comparison of Two Types of 1-L Polyethylene Glycol-ascorbic Acid as Colonoscopic Bowel Preparation: A Prospective Randomized Study. THE KOREAN JOURNAL OF GASTROENTEROLOGY = TAEHAN SOHWAGI HAKHOE CHI 2022; 80:85-92. [PMID: 36004636 DOI: 10.4166/kjg.2022.090] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/05/2022] [Revised: 07/16/2022] [Accepted: 07/20/2022] [Indexed: 06/15/2023]
Abstract
BACKGROUND/AIMS Recently, 1-L polyethylene glycol-ascorbic acid (PEG-Asc) has been used to reduce the volume of preparation agents in colonoscopy. This clinical trial aimed to compare the efficacy and safety of two types of 1-L PEG-Asc (CleanViewAL® [Tae Joon Pharmaceutical Company, Seoul, Korea] and Plenvu® [Norgine, Harefield, United Kingdom]) in average-aged adults. METHODS This study was a prospective, randomized, non-inferiority, open-label, phase 4 clinical trial. The primary endpoint was the efficacy evaluated using the Boston bowel preparation scale (BBPS), and the secondary endpoint was clinical safety. RESULTS In total, 173 patients were assigned to either the CleanViewAL® (n=84) or Plenvu® (n=89) group. Overall cleansing successes of 97.6% (82/84) and 98.8% (88/89) were achieved in the CleanViewAL® group and in the Plenvu® group, respectively, showing that CleanViewAL® has similar bowel cleansing efficacy to Plenvu® (95% CI, -0.052 to 0.027; p=0.207). The total BBPS score was 8.67±1.00 and 8.70±0.76 in the CleanViewAL® group and Plenvu® group, respectively (p=0.869). The most common adverse symptom was nausea, and no adverse symptoms requiring hospitalization were reported in either group. There were no cases of critical hypernatremia and liver dysfunction exceeding the common terminology criteria for adverse events grade I. An overall satisfaction score (scale of 1 to 10) showed no difference between the two groups (p=0.289). However, the CleanViewAL® group showed a higher taste satisfaction score (scale of 1 to 5) than the Plenvu® group (CleanViewAL®: 2.90±0.91, Plenvu®: 2.60±0.86, p=0.028). CONCLUSIONS Both types of 1-L PEG-Asc, CleanViewAL® and Plenvu®, are effective and safe bowel cleansing agents in average-aged adults. CleanViewAL® was preferred in terms of taste satisfaction.
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Affiliation(s)
- Suh Hyun Choi
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Won Eui Yoon
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Seung Hyuk Kim
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Hee Jun Myung
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Seo Hyun Kim
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Soon Oh So
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Se Hun Kim
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Hyun Mi Lee
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Yeoun Jung Oh
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
- Department of Nursing, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Jeong Seop Moon
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Tae Yeong Park
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
- Division of Gastroenterology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
| | - You Sun Kim
- Division of Gastroenterology, Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
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20
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Alfred S, Chedgy F. A retrospective, comparative study between Plenvu and Moviprep as bowel preparation agents for colonoscopy. Clin Med (Lond) 2022; 22:1. [PMID: 36220230 PMCID: PMC9600805 DOI: 10.7861/clinmed.22-4-s1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Affiliation(s)
- Sarah Alfred
- Eastbourne District General Hospital, Eastbourne, UK
| | - Fergus Chedgy
- University Hospitals Sussex NHS Foundation Trust, Brighton, UK
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21
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Barkun AN, Martel M, Epstein IL, Hallé P, Hilsden RJ, James PD, Rostom A, Sey M, Singh H, Sultanian R, Telford JJ, von Renteln D. The Bowel CLEANsing National Initiative: High-Volume Split-Dose Vs Low-Volume Split-Dose Polyethylene Glycol Preparations: A Randomized Controlled Trial. Clin Gastroenterol Hepatol 2022; 20:e1469-e1477. [PMID: 34509641 DOI: 10.1016/j.cgh.2021.09.005] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/04/2021] [Revised: 08/31/2021] [Accepted: 09/01/2021] [Indexed: 02/05/2023]
Abstract
BACKGROUND & AIMS The aim of this study was to compare high-volume polyethylene glycol (PEG) with low-volume PEG with bisacodyl split-dosing regimens. METHODS Adult outpatients in 10 Canadian tertiary hospitals were randomized, stratified by morning or afternoon colonoscopy, to high-volume split-dose PEG (2 L + 2 L) (High-SD) or low volume (1 L + 1 L) + bisacodyl (15 mg) PEG (Low-SD), with a second randomization to liquid or low-residue diets. The primary end point, using noninferiority hypothesis testing, was adequate bowel cleansing (Boston Bowel Preparation Scale total score of ≥6, with each of 3 colonic segments subscores ≥2). Secondary objectives were willingness to repeat the preparation, withdrawal time, cecal intubation, and polyp detection rates. RESULTS Over 29 months, 2314 subjects were randomized to High-SD (N = 1157) or Low-SD (N = 1157) (mean age, 56.2 ± 13.4 y; 52.1% women). Colonoscopy indications were 38.2% diagnostic, 36.8% screening, and 25.0% surveillance, with no between-group imbalances in patient characteristics. Low-SD satisfied noninferiority criteria vs High-SD for adequate bowel cleanliness with only marginally inferior results (90.1% vs 88.1%; P = .02; difference, 2.0%; 95% CI [0.0%; 4.5%]). High-SD was associated with lower willingness to repeat (66.9% vs 91.9%; P < .01), was less well tolerated (7.3 ± 2.3 vs 8.1 ± 1.9; P < .01), causing more symptoms. No differences in procedural outcomes were noted except for more frequent cecal intubation rates after High-SD (97.4% vs 95.6%; P = .02). Among the High-SD group, adequate bowel preparation was greater after a clear liquid diet (93.6% vs 87.9%; P < .01), a finding not seen in the Low-SD group. CONCLUSIONS Low-SD is noninferior to High-SD in providing adequate bowel preparation. Low-SD results in fewer symptoms, with greater willingness to repeat and tolerability. The overall impact of diet was modest.The study was approved by the research ethic boards from all sites and was registered at ClinicalTrials.gov (NCT02547571).
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Affiliation(s)
- Alan N Barkun
- Division of Gastroenterology, Department of Medicine, McGill University Health Center, McGill University, Montreal, Quebec, Canada.
| | - Myriam Martel
- Division of Gastroenterology, Department of Medicine, McGill University Health Center, McGill University, Montreal, Quebec, Canada
| | - Ian L Epstein
- Division of Digestive Care & Endoscopy, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
| | - Pierre Hallé
- Division of Gastroenterology, Department of Medicine, University Hospital of Quebec-Université Laval, Québec, Canada
| | - Robert J Hilsden
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Paul D James
- Division of Gastroenterology, Department of Medicine, University Health Network, Toronto, Ontario, Canada
| | - Alaa Rostom
- Division of Gastroenterology, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Michael Sey
- Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada
| | - Harminder Singh
- Research Institute in Oncology and Hematology, CancerCare Manitoba and Department of Internal Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
| | - Richard Sultanian
- Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
| | - Jennifer J Telford
- Division of Gastroenterology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
| | - Daniel von Renteln
- Division of Gastroenterology, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada
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22
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Bednarska O, Nyhlin N, Schmidt PT, Johansson GW, Toth E, Lindfors P. The Effectiveness and Tolerability of a Very Low-Volume Bowel Preparation for Colonoscopy Compared to Low and High-Volume Polyethylene Glycol-Solutions in the Real-Life Setting. Diagnostics (Basel) 2022; 12:diagnostics12051155. [PMID: 35626310 PMCID: PMC9140572 DOI: 10.3390/diagnostics12051155] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2022] [Revised: 04/30/2022] [Accepted: 04/30/2022] [Indexed: 02/04/2023] Open
Abstract
Adequate bowel cleansing is essential for high-quality colonoscopy. Recently, a new very low-volume 1 litre (1L) polyethylene glycol (PEG) plus ascorbate solution (ASC) has been introduced. Our aims were to assess the effectiveness and tolerability of this product compared to low-volume 2L PEG-ASC and high-volume 4L PEG solutions, in a real-life setting. In six endoscopy units in Sweden, outpatients undergoing colonoscopy were either prescribed solutions according to local routines, or the very low-volume solution in split dose regimen. Bowel cleansing effectiveness and patient experience was assessed using the Boston Bowel preparation scale (BBPS) and a patient questionnaire. A total of 1098 patients (mean age 58 years, 52% women) were included. All subsegment and the total BBPS scores were significantly greater for 1L PEG-ASC in comparison to other solutions (p < 0.05 for 1L PEG-ASC and 4L PEG for transverse and left colon, otherwise p < 0.001). Nausea was more frequent with 1L PEG-ASC compared to 2L PEG-ASC (p < 0.001) and vomiting were more often reported compared to both other solutions (p < 0.01 and p < 0.05 for 2L PEG-ASC and 4L PEG, respectively). Smell, taste, and total experience was better for 1L PEG-ASC compared to 4L PEG (p < 0.001), and similar compared to the 2L PEG-ASC. In conclusion, 1L PEG-ASC leads to better bowel cleansing compared to 2L PEG-ASC or 4L PEG products, with similar or greater patient satisfaction.
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Affiliation(s)
- Olga Bednarska
- Department of Gastroenterology, Linköping University Hospital, S-581 85 Linköping, Sweden
- Correspondence: (O.B.); (N.N.); Tel.: +46-19-6022361 (N.N.)
| | - Nils Nyhlin
- Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, S-701 85 Örebro, Sweden
- Correspondence: (O.B.); (N.N.); Tel.: +46-19-6022361 (N.N.)
| | - Peter Thelin Schmidt
- Department of Medicine, Ersta Hospital, S-116 91 Stockholm, Sweden; or
- Department of Medicine, Karolinska Institutet, S-171 77 Solna, Sweden
| | - Gabriele Wurm Johansson
- Department of Gastroenterology, Skåne University Hospital, Lund University, S-205 02 Malmö, Sweden; (G.W.J.); (E.T.)
| | - Ervin Toth
- Department of Gastroenterology, Skåne University Hospital, Lund University, S-205 02 Malmö, Sweden; (G.W.J.); (E.T.)
| | - Perjohan Lindfors
- Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, S-171 77 Solna, Sweden; or
- Aleris Gastromottagningen City, S-111 37 Stockholm, Sweden
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23
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Hong SN, Lee CK, Im JP, Choi CH, Byeon JS, Cho YS, Jung SA, Kim TI, Jeen YT. Efficacy and safety of split-dose bowel preparation with 1 L polyethylene glycol and ascorbate compared with 2 L polyethylene glycol and ascorbate in a Korean population: a phase IV, multicenter, randomized, endoscopist-blinded study. Gastrointest Endosc 2022; 95:500-511.e2. [PMID: 34653425 DOI: 10.1016/j.gie.2021.09.041] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/05/2021] [Accepted: 09/27/2021] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS The 1-L polyethylene glycol (PEG)-based bowel preparation agent NER1006 (Plenvu; Norgine, Harefield, UK) has shown high cleansing efficacy and tolerability in clinical trials in Europe and North America. However, no clinical trials have yet been reported in Asia. Therefore, the aim of this study was to evaluate the efficacy and safety of 1L PEG-based bowel preparation with Plenvu compared with 2L PEG plus ascorbate bowel preparation in a Korean population. METHODS In this multicenter, endoscopist-blinded, randomized study, patients at 9 hospitals in South Korea undergoing colonoscopy received either Plenvu or 2L PEG + ascorbate (2L PEG) with a split dose. The primary endpoint was overall bowel cleansing success (Boston Bowel Preparation Scale [BBPS] score ≥2 for all segments of the colon). Secondary endpoints were high-quality bowel cleansing success (overall, BBPS score = 9; segmental colon, BPPS score = 3), polyp detection rate (PDR), and adenoma detection rate (ADR). RESULTS Of 360 included patients, cleansing efficacy was analyzed in 346 (Plenvu, 174; 2L PEG, 172). The Plenvu group showed noninferior bowel cleansing success rates compared with 2L PEG (93.10% vs 91.86%; difference, 1.24%; 1-sided 97.5% lower confidence limit, -4.31%; Pnoninferiority < .0001; Psuperiority = .661). The Plenvu group had higher high-quality bowel cleansing success rates for overall and right-sided colon segments than the 2L PEG group (49.43% vs 37.79% [P = .029] and 60.92% vs 48.84% [P = .024], respectively). The PDR was greater with Plenvu than with 2L PEG (48.85% vs 37.79%, P = .038). However, ADR did not differ between the 2 groups (24.71% vs 20.35%, P = .331). Although treatment-emergent adverse events (TEAEs) were slightly higher in the Plenvu group than in the 2L PEG group (65.71% vs 52.91%, P = .015), most TEAEs were mild (85.55%) and most patients recovered without any management (99.23%). CONCLUSIONS Plenvu showed noninferior overall bowel cleansing success rates comparable with 2L PEG but greater high-quality bowel cleansing in overall and right-sided colon, which might help improve the PDR in the Asian population. (Clinical trial registration number: KCT0005894.).
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Affiliation(s)
- Sung Noh Hong
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Chang Kyun Lee
- Department of Gastroenterology and Hepatology, Kyung Hee University School of Medicine, Seoul, Korea
| | - Jong Pil Im
- Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Chang Hwan Choi
- Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
| | - Jeong-Sik Byeon
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Young-Seok Cho
- Department of Internal Medicine, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Korea
| | - Sung-Ae Jung
- Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea
| | - Tae Il Kim
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - Yoon Tae Jeen
- Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea
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24
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Manning J, Halonen J, Cheriyamkunnel SJ, Álvarez-González MA. 1L NER1006 can improve rates of adequate and high-quality bowel cleansing in the right colon: a post hoc analysis of two randomised clinical trials. BMC Gastroenterol 2022; 22:35. [PMID: 35078404 PMCID: PMC8787873 DOI: 10.1186/s12876-022-02106-2] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/28/2021] [Accepted: 01/05/2022] [Indexed: 12/12/2022] Open
Abstract
BACKGROUND The right colon is difficult to cleanse compared with other colon segments. This post hoc analysis of two randomised clinical trials (MORA and NOCT) examined whether 1L polyethylene glycol (PEG) NER1006 and two mid-volume alternatives could improve adequate and high-quality cleansing in the right colon among patients with complete cleansing assessments. METHODS Patients received NER1006 (N2D), 2L PEG plus ascorbate (2LPEG) or oral sulphate solution (OSS) as a 2-day evening/morning split-dosing regimen or NER1006 as a same-day morning-only dosing regimen (N1D). Patients had full segmental scoring assigned by treatment-blinded central readers using the Harefield Cleansing Scale. The right colon adequate (score ≥ 2) and high-quality (score ≥ 3) cleansing success of NER1006 (N2D and N1D) versus 2LPEG and OSS was analysed individually and as pooled groups (N2D vs. 2LPEG/OSS). We assessed the comparative right colon cleansing rates of the N2D versus 2LPEG/OSS in overweight males. We also performed a multivariable regression analysis to examine factors affecting cleansing in the right colon. RESULTS A total of 1307 patients were included. Pooled N2D showed significantly improved rates of adequate-level cleansing in the right colon compared with 2LPEG (97.5% [504/517] vs. 94.6% [246/260]; p = 0.020) and OSS (97.5% [504/517] vs. 93.8% [244/260]; p = 0.006). In MORA, the rate of adequate right colon cleansing did not significantly differ between N1D and 2LPEG (95.2% [257/270] vs. 94.6% [246/260]; p = 0.383). The rate of right colon high-quality cleansing was significantly improved with N2D or N1D vs. 2LPEG (p < 0.001 for both), and was numerically higher with N2D versus OSS (p = 0.11). In overweight males, NER1006 delivered numerically higher adequate (p = 0.398) and superior high-quality (p = 0.024) cleansing rates versus 2LPEG/OSS. Multivariable regression analysis showed NER1006 was associated with adequate and high-quality cleansing (p = 0.031 and p < 0.001), while time between preparation and colonoscopy was negatively associated (p = 0.034 and p = 0.006). CONCLUSIONS NER1006 delivered improved rates of adequate and high-quality right colon cleansing compared with 2LPEG and OSS. The increased rate of high-quality cleansing with NER1006 versus its comparators was also seen in overweight males.
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Affiliation(s)
- Jonathan Manning
- Borders General Hospital, NHS Borders, Melrose, Berwickshire, UK
| | - Juha Halonen
- Norgine Ltd, Medical Affairs, Widewater Place Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK.
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25
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Occhipinti V, Soriani P, Bagolini F, Milani V, Rondonotti E, Annunziata ML, Cavallaro F, Vavassori S, Vecchi M, Pastorelli L, Tontini GE. Efficacy and tolerability of high and low-volume bowel preparation compared: A real-life single-blinded large-population study. World J Gastrointest Endosc 2021; 13:659-672. [PMID: 35070027 PMCID: PMC8716982 DOI: 10.4253/wjge.v13.i12.659] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/24/2021] [Revised: 06/25/2021] [Accepted: 12/03/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Low-volume preparations for colonoscopy have shown similar efficacy compared to high-volume ones in randomized controlled trials (RCT). However, most RCTs do not provide data about clinical outcomes including lesions detection rate. Moreover, real-life comparisons are lacking.
AIM To compare efficacy (both in terms of adequate bowel preparation and detection of colorectal lesions) and tolerability of a high-volume (HV: 4 L polyethylene glycol, PEG) and a low-volume (LV: 2 L PEG plus bisacodyl) bowel preparation in a real-life setting.
METHODS Consecutive outpatients referred for colonoscopy were prospectively enrolled between 1 December 2014 and 31 December 2016. Patients could choose either LV or HV preparation, with a day-before schedule for morning colonoscopies and a split-dose for afternoon procedures. Adequate bowel preparation according to Boston Bowel Preparation Scale (BBPS), clinical outcomes including polyp detection rate (PDR), adenoma detection rate (ADR), advanced adenoma detection rate (AADR), sessile/serrated lesion detection rate (SDR) and cancer detection rate and self-reported tolerability of HV and LV were blindly assessed.
RESULTS Total 2040 patients were enrolled and 1815 (mean age 60.6 years, 50.2% men) finally included. LV was chosen by 52% of patients (50.8% of men, 54.9% of women). Split-dose schedule was more common with HV (44.7% vs 38.2%, P = 0.005). High-definition scopes were used in 33.4% of patients, without difference in the two groups (P = 0.605). HV and LV preparations showed similar adequate bowel preparation rates (89.2% vs 86.6%, P = 0.098), also considering the two different schedules (HV split-dose 93.8% vs LV split-dose 93.6%, P = 1; HV day-before 85.5% vs LV day-before 82.3%, P = 0.182). Mean global BBPS score was higher for HV preparations (7.1 ± 1.7 vs 6.8 ± 1.6, P < 0.001). After adjustment for sex, age and indications for colonoscopy, HV preparation resulted higher in PDR [Odds ratio (OR) 1.32, 95%CI: 1.07-1.63, P = 0.011] and ADR (OR 1.29, 95%CI 1.02–1.63, P = 0.038) and comparable to LV in AADR (OR 1.51, 95%CI 0.97-2.35, P = 0.069), SDR and cancer detection rate. The use of standard-definition colonoscopes was associated to lower PDR (adjusted OR 1.59, 95%CI: 1.22-2.08, P < 0.001), ADR (adjusted OR 1.71, 95%CI: 1.26–2.30, P < 0.001) and AADR (adjusted OR 1.97, 95%CI: 1.09-3.56, P = 0.025) in patients receiving LV preparation. Mean Visual Analogue Scale tolerability scored equally (7, P = 0.627) but a ≥ 75% dose intake was more frequent with LV (94.6% vs 92.1%, P = 0.003).
CONCLUSION In a real-life setting, PEG-based low-volume preparation with bisacodyl showed similar efficacy and tolerability compared to standard HV preparation. However, with higher PDR and ADR, HV should still be considered as the reference standard for clinical trials and the preferred option in screening colonoscopy, especially when colonoscopy is performed with standard resolution imaging.
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Affiliation(s)
- Vincenzo Occhipinti
- Digestive Endoscopy and Gastroenterology Unit, A. Manzoni Hospital, ASST Lecco, Lecco 23900, Italy
- Gastro-enterology Unit, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
| | - Paola Soriani
- Gastro-enterology Unit, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
- Gastroenterology and Digestive Endoscopy Unit, Azienda USL Modena, Carpi Hospital, Carpi 41012, Italy
| | - Francesco Bagolini
- Gastro-enterology Unit, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
| | - Valentina Milani
- Scientific Directorate, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
| | | | | | - Flaminia Cavallaro
- Gastro-enterology Unit, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan 20122, Italy
| | - Sara Vavassori
- Gastro-enterology Unit, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
- Gastroenterology and Hepatology Unit, ASST Santi Paolo e Carlo, Milan 20142, Italy
| | - Maurizio Vecchi
- Gastro-enterology Unit, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan 20122, Italy
- Department of Pathophysiology and Transplantation, University of Milan, Milan 20122, Italy
| | - Luca Pastorelli
- Gastro-enterology Unit, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
- Gastroenterology and Hepatology Unit, ASST Santi Paolo e Carlo, Milan 20142, Italy
- Department of Biomedical Sciences for Health, University of Milan, Milan 20122, Italy
| | - Gian Eugenio Tontini
- Gastro-enterology Unit, IRCCS Policlinico San Donato, San Donato Milanese 20097, Italy
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan 20122, Italy
- Department of Pathophysiology and Transplantation, University of Milan, Milan 20122, Italy
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26
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Maida M, Morreale GC, Sferrazza S, Sinagra E, Scalisi G, Vitello A, Vettori G, Rossi F, Catarella D, Di Bartolo CE, Schillaci D, Raimondo D, Camilleri S, Orlando A, Macaluso FS. Effectiveness and safety of 1L PEG-ASC preparation for colonoscopy in patients with inflammatory bowel diseases. Dig Liver Dis 2021; 53:1171-1177. [PMID: 33994129 DOI: 10.1016/j.dld.2021.04.006] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/16/2021] [Revised: 03/19/2021] [Accepted: 04/08/2021] [Indexed: 12/11/2022]
Abstract
INTRODUCTION The effectiveness of bowel cleansing is a key element for high-quality colonoscopy. Recently, a 1 L polyethylene glycol plus ascorbate (PEG-ASC) solution has been introduced, but effectiveness and safety of this preparation have not been assessed in IBD patients. This study aims to evaluate effectiveness and safety of 1 L PEG-ASC solution in patients with IBD compared to controls. METHODS We retrospectively analysed prospectively collected data on a cohort of 411 patients performing a colonoscopy after preparation with 1 L PEG-ASC, consecutively enrolled in 5 Italian centres. RESULTS Overall, 185/411 (45%) were patients with IBD and 226/411 (55%) served as controls. A significantly higher cleansing success was achieved in IBD patients (92.9% vs 85.4%, p = 0.02). The multiple regression model showed that presence of IBD (OR=2.514, 95%CI=1.165-5.426; P = 0.019), lower age (OR=0.981, 95%CI=0.967-0.996; P = 0.014), split preparation (OR=2.430, 95%CI=1.076-5.492; P = 0.033), absence of diabetes (OR=2.848, 95%CI=1.228-6.605; P = 0.015), and of chronic constipation (OR=3.350, 95%CI=1.429-7.852; P = 0.005), were independently associated with cleansing success. The number of treatment-emergent adverse events (TEAEs) (51 vs 62%, p = 0.821), and of patients with TEAEs (22.2% vs 21.2%, p = 0.821), were similar in IBD patients and in controls, respectively. CONCLUSIONS Results from this study support the effectiveness and safety of 1 L PEG-ASC solution in IBD patients, which may improve the definition of endoscopic outcomes both in Crohn's disease and ulcerative colitis.
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Affiliation(s)
- M Maida
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy.
| | - G C Morreale
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy
| | - S Sferrazza
- Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, Trento, Italy
| | - E Sinagra
- Gastroenterology and Endoscopy Unit, Fondazione Istituto San Raffaele Giglio, Cefalù, Italy
| | - G Scalisi
- Gastroenterology Unit, ARNAS Garibaldi, Catania, Italy
| | - A Vitello
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy
| | - G Vettori
- Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, Trento, Italy
| | - F Rossi
- Gastroenterology and Endoscopy Unit, Fondazione Istituto San Raffaele Giglio, Cefalù, Italy
| | - D Catarella
- Gastroenterology Unit, ARNAS Garibaldi, Catania, Italy
| | | | - D Schillaci
- Gastroenterology Unit, Basarocco Hospital, Niscemi, Italy
| | - D Raimondo
- Gastroenterology and Endoscopy Unit, Fondazione Istituto San Raffaele Giglio, Cefalù, Italy
| | - S Camilleri
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy
| | - A Orlando
- IBD Unit, Villa Sofia-Cervello Hospital, Palermo, Italy
| | - F S Macaluso
- IBD Unit, Villa Sofia-Cervello Hospital, Palermo, Italy
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27
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Epstein M, Halonen J, Sharma P. Bowel preparation with 1L polyethylene glycol and ascorbate NER1006 doubles the chance to detect three or more adenomas in overweight or obese males. Endosc Int Open 2021; 9:E1324-E1334. [PMID: 34466355 PMCID: PMC8367431 DOI: 10.1055/a-1499-6681] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/18/2020] [Accepted: 04/12/2021] [Indexed: 12/28/2022] Open
Abstract
Background and study aims Men have more colon cleansing failures, colorectal adenomas, and colorectal cancers than women. We analyzed whether 1-liter (1 L) polyethylene glycol (PEG) NER1006 improves high-quality (HQ) colon cleansing and adenoma detection in males versus two mid-volume alternatives. Patients and methods The analysis of 1028 adult patients in two randomized clinical trials was performed. Adenoma detection and HQ cleansing were compared for overnight split dosing regimens with NER1006 (n = 513) versus combined oral sulfate solution or 2 L PEG + ascorbate (OSS/2 L PEG) (n = 515). Analyses included males versus females, overweight or obese (OO) males versus lean males, and NER1006 versus OSS/2 L PEG. In male patients, the adenoma detection rate of at least 3 (ADR3 +) was predicted with multiple logistic regression and statistical comparisons used the two-sided t-test. Results ADR3 + was greater in males versus females (10.7 % [56/524] versus 5.8 % [29/504]; P = 0.004) despite comparable adequate cleansing success rates (93.2 % [479/514] versus 93.0 % [466/501]; P = 0.912) and more HQ-scores in females (41.6 % [1069/2570] versus 45.3 % [1134/2505]; P = 0.008). ADR was almost twice as high in OO versus lean males (43.4 % [184/424] versus 23.1 % [21/91]; P < 0.001). Multivariate logistic regression predicted ADR3 + detection to be twice as likely in OO males using NER1006 versus OSS/2 L PEG (odds ratio (95 % confidence interval [CI]) = 2.049 (1.082-3.973); P = 0.030) and 90 % more likely in all males (1.902 (1.045-3.526); P = 0.037). In males, including OO males, NER1006 attained more HQ-scores per trial than OSS or 2 L PEG (P ≤ 0.017 for all comparisons). Conclusions NER1006 predicted the detection of more males for frequent surveillance than OSS/2 L PEG.
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Affiliation(s)
- Michael Epstein
- Investigative Clinical Research, Annapolis, Maryland, United States
| | - Juha Halonen
- Medical Affairs, Norgine Ltd., Harefield, United Kingdom
| | - Prateek Sharma
- Department of Gastroenterology and Hepatology, Veterans Affairs Medical Center, Kansas City, Missouri, United States,Department of Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, Kansas, United States
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Baile-Maxia S, Amlani B, Martínez RJ. Bowel-cleansing efficacy of the 1L polyethylene glycol-based bowel preparation NER1006 (PLENVU) in patient subgroups in two phase III trials. Therap Adv Gastroenterol 2021; 14:17562848211020286. [PMID: 34249144 PMCID: PMC8237221 DOI: 10.1177/17562848211020286] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/18/2020] [Accepted: 05/06/2021] [Indexed: 02/04/2023] Open
Abstract
BACKGROUND Adequate bowel preparation prior to colonoscopy is essential for visualization of the colonic mucosa to maximize adenoma and polyp detection. The risk of inadequate bowel cleansing is heightened if the patient is older, male, overweight, and has comorbidities, such as diabetes. This post hoc analysis of the combined MORA and NOCT clinical trials explores the efficacy of evening/morning split-dose regimens of NER1006 (PLENVU®, Norgine Ltd), a 1-liter polyethylene glycol (PEG) bowel preparation, to evaluate its bowel-cleansing efficacy in patients at risk for inadequate cleansing. METHODS Patients requiring colonoscopy were randomized to receive evening/morning split-dosing of either NER1006, 2-liter (2L) PEG and ascorbate, or oral sulfate solution (OSS). Bowel-cleansing efficacy was assessed by treatment-blinded central readers using the validated Harefield Cleansing Scale (HCS). RESULTS Split-dose NER1006 was associated with high levels of cleansing, ranging between 87.0% and 94.0% across all patient subtypes (n = 551), including patients with obesity or diabetes. However, patients aged >65 years and <45 years showed significantly greater rates of successful cleansing than patients aged 45-65 years (94.0% versus 94.2% versus 87.0%, p = 0.002). The high-risk patient subgroup, which included obese males aged ⩾60 years, had significantly improved overall and high-quality bowel-cleansing success rates of 100% (33/33) and 72.7% (27/33) on the HCS with NER1006, compared with 86.7% (26/30) and 50% (15/30) with the comparator solutions (p = 0.015 and p = 0.033, respectively). In this high-risk subgroup, adenoma detection was greater per patient receiving NER1006 versus the comparator group (1.82 versus 0.93, p = 0.041). NER1006 was the only treatment that enabled the detection of patients with ⩾5 adenomas [9.1% (3/33) versus 0/30, p = 0.047]. CONCLUSION NER1006 effectively cleansed a broad range of patients and offered superior bowel cleansing versus 2LPEG/OSS in patients at increased risk of colorectal cancer. Future research should establish whether more effective cleansing also enables improved adenoma detection. PLAIN LANGUAGE SUMMARY A low-volume bowel preparation solution to better detect lesions associated with colorectal cancer during colonoscopyColorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world. Obese men over the age of 65 years are at particularly increased risk of developing CRC. If the changes in their large intestine (colon) could be seen more clearly during a colonoscopy (where a small camera is inserted via the anus to examine the bowels from the inside), patients who need treatment would be diagnosed earlier, thus improving their chances of survival. In this paper we discuss the use of a bowel preparation solution that is more convenient for patients (less to drink) but also cleans bowels more effectively, meaning more lesions are detected than when other solutions are used. This improved cleansing, and thus better visualization, occurred in a range of patients, including those at higher risk of CRC, such as older, overweight men.
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Affiliation(s)
- Sandra Baile-Maxia
- Gastroenterology Department, Hospital General
Universitario de Alicante, Instituto de Investigación Biomédica ISABIAL,
Alicante, Spain
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Sinagra E, Sferrazza S, Vitello A, Morreale G, Rossi F, Conoscenti G, Pallio S, Raimondo D, Maida M. Effectiveness and Tolerability of Very-low Volume Preparation for Colonoscopy: A Narrative Review. Curr Drug Metab 2021; 22:85-88. [PMID: 33292108 DOI: 10.2174/1389200221999201208212007] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2020] [Revised: 09/15/2020] [Accepted: 09/22/2020] [Indexed: 11/22/2022]
Abstract
An adequate bowel preparation is essential for a successful colonoscopy, in particular, in the setting of colorectal cancer screening. However, up to one-quarter of colonoscopies are associated with inadequate bowel preparation, which may result in reduced polyp and adenoma detection rates, prolonged procedural time, and an increased likelihood of repeat the procedure. The ideal intestinal preparation should provide an optimal observation of the mucosa (at least > 90% of the visible surface), with adequate acceptability and safety for the patient. With this premise, a very low-volume 1 L PEG-ASC solution (Plenvu; Norgine, Harefield, United Kingdom) has been recently introduced to improve patients' experience in colonoscopy by reducing the total intake of liquids to be consumed. This could represent a valid option for bowel cleansing, considering CRC screening and surveillance programs, improving both the quality of the examination and the patients' compliance. Nevertheless, it must be emphasized that a "one size fits all" preparation strategy is not feasible and that a bowel preparation regime must always be selected and tailored by the clinician for each patient, evaluating the best options on a case by case basis. This narrative review aims to sum up the evidence regarding new bowel preparation regimens in order to help clinicians to tailor the best choice for patients undergoing colonoscopy.
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Affiliation(s)
- Emanuele Sinagra
- Gastroenterology and Endoscopy Unit, Istituto San Raffaele Giglio, Cefalu, Italy
| | - Sandro Sferrazza
- Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, Trento, Italy
| | - Alessandro Vitello
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy
| | - Gaetano Morreale
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy
| | - Francesca Rossi
- Gastroenterology and Endoscopy Unit, Istituto San Raffaele Giglio, Cefalu, Italy
| | - Giuseppe Conoscenti
- Gastroenterology and Endoscopy Unit, Istituto San Raffaele Giglio, Cefalu, Italy
| | - Socrate Pallio
- Digestive Diseases Endoscopy Unit, Policlinico G. Martino Hospital, University of Messina, Messina, Italy
| | - Dario Raimondo
- Gastroenterology and Endoscopy Unit, Istituto San Raffaele Giglio, Cefalu, Italy
| | - Marcello Maida
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy
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Ohmiya N, Nakagawa Y, Horiguchi N, Omori T, Kamano T, Funasaka K, Nagasaka M, Shibata T. Safety of Polyethylene Glycol Solution plus Ascorbic Acid for Bowel Preparation for Colonoscopy in Patients with Chronic Kidney Disease. Gastroenterol Res Pract 2021; 2021:6696591. [PMID: 33815499 PMCID: PMC7987408 DOI: 10.1155/2021/6696591] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/03/2020] [Revised: 02/08/2021] [Accepted: 02/27/2021] [Indexed: 12/27/2022] Open
Abstract
INTRODUCTION Polyethylene glycol-electrolyte lavage solution plus ascorbic acid (PEG-ELS-Asc) has been recommended for colonoscopy, but little is known about the safety of PEG-ELS-Asc in patients with chronic kidney disease (CKD). The aim of this study was to determine its safety and efficacy in CKD patients. METHODS Blood and urine samples prospectively collected before and after same-day bowel preparation for colonoscopy with the conventional volume of PEG-ELS-Asc, vital signs before and after colonoscopy, and adverse events within 30 days postcolonoscopy were analyzed in consenting patients with CKD. The cleansing level was evaluated with the Boston bowel preparation score (BBPS) from colonoscopic findings. RESULTS Of 57 patients enrolled, 1 was excluded for refusal. Serum bicarbonate significantly dropped, and blood hemoglobin, serum total protein, albumin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, and uric acid significantly rose after bowel preparation, although these changes were not clinically important. Only in nondialysis patients did the platelet count and potassium significantly rise, although these changes were not clinically important either. Renal function, such as the urea, creatinine, and estimated glomerular filtration rate, was not significantly altered. An adequate bowel cleansing score, BBPS ≥ 6, was achieved in 94% of patients. The blood pressure and heart rate were not significantly different between before and after colonoscopy in either nondialysis (n = 32) or dialysis (n = 19) patients. There were no adverse events associated with bowel preparation and colonoscopy within 30 days postcolonoscopy. CONCLUSIONS The conventional volume of same-day bowel preparation with PEG-ELS-Asc may be safe and effective in CKD patients.
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Affiliation(s)
- Naoki Ohmiya
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan
| | - Yoshihito Nakagawa
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan
| | - Noriyuki Horiguchi
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan
| | - Takafumi Omori
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan
| | - Toshiaki Kamano
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan
| | - Kohei Funasaka
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan
| | - Mitsuo Nagasaka
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan
| | - Tomoyuki Shibata
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan
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Maida M, Macaluso FS, Sferrazza S, Ventimiglia M, Sinagra E. Effectiveness and safety of NER1006 versus standard bowel preparations: A meta-analysis of randomized phase-3 clinical trials. Dig Liver Dis 2020; 52:833-839. [PMID: 32586765 DOI: 10.1016/j.dld.2020.05.046] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/14/2020] [Revised: 05/19/2020] [Accepted: 05/26/2020] [Indexed: 12/11/2022]
Abstract
BACKGROUND A 1 L PEG-based preparation for colonoscopy (NER1006) has been recently developed. AIMS We conducted a meta-analysis of randomized controlled trials (RCTs) to explore the effectiveness and safety of NER1006 versus traditional preparations. METHODS PubMed/Medline and Embase were systematically searched through January 2020 for phase-3 RCTs comparing NER1006 versus standard preparations. RESULTS Three RCTs (1879 participants) met the inclusion criteria and were included. The analysis showed a higher cleansing success for NER1006 compared standard preparations (OR=1.28; 95% CI 1.00-1.62; p = 0.047, I2=0%) as well as a greater high-quality cleansing of the right colon (OR=2.13; 95% CI 1.16-3.94; p = 0.015, I2=76.0%) when assessed by the Harefield Cleansing Scale (HCS). The pooled estimate of the NER1006 effect on ADR showed a higher, although not significant, ADR of the right colon (OR=1.19; 95% CI 0.73-1.92; p = 0.485, I2=53%). When considering the impact of NER1006 on mild to moderate treatment-emergent adverse events (TEAEs), we observed a significant pooled estimate of TEAEs (OR=2.31; 95% CI 1.82-2.94; p<0.001, I2=0%). CONCLUSIONS When compared to traditional preparations, NER1006 showed a better overall cleansing of the colon as well as a greater high-quality cleansing of the right colon, with comparable ADR. A higher incidence of mild to moderate TEAEs was observed for NER1006, in the absence of serious adverse events.
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Affiliation(s)
- M Maida
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, Caltanissetta, Italy.
| | - F S Macaluso
- IBD Unit, Villa Sofia-Cervello Hospital, Palermo, Italy
| | - S Sferrazza
- Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, Trento, Italy
| | - M Ventimiglia
- IBD Unit, Villa Sofia-Cervello Hospital, Palermo, Italy
| | - E Sinagra
- Gastroenterology and Endoscopy Unit, Fondazione Istituto San Raffaele Giglio, Cefalù, Italy
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