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Akram U, Ahmed S, Fatima E, Ahmad E, Ashraf H, Hassan SA, Qureshi Z, Altaf F, Buckles D, Iqbal J, Mohamed Ahmed KAH. Efficacy and safety of oral sulfate solution versus polyethylene glycol for colonoscopy: A systematic review and meta-analysis of randomized controlled trials. DEN OPEN 2025; 5:e70113. [PMID: 40248440 PMCID: PMC12003215 DOI: 10.1002/deo2.70113] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 12/18/2024] [Revised: 03/26/2025] [Accepted: 03/30/2025] [Indexed: 04/19/2025]
Abstract
Background Colonoscopy is the gold standard for early detection and monitoring of colorectal cancer. Procedural effectiveness is dependent on optimal bowel preparation. Traditional polyethylene glycol (PEG) solutions are difficult to tolerate, whereas newer low-volume alternatives, including PEG with ascorbic acid and oral sulfate solutions (OSS), offer improved efficacy and tolerability. The meta-analysis was performed to evaluate the efficacy and safety of OSS compared to PEG for bowel preparation in colonoscopy. Methods Studies were identified by searching PubMed, Embase, Cochrane CENTRAL, and clinicaltrials.gov from inception until June 2024. Only randomized controlled trials comparing OSS with PEG were included. Data was analyzed using R version 4.4.0 using a random effects model to calculate risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs). Results Twenty-one studies with 6346 participants met the inclusion criteria. OSS significantly improved adenoma detection (RR, 1.13; 95% CI, 1.04-1.22; p-value <0.01; I2 = 0%) and polyp detection rates (RR, 1.16; 95% CI, 1.06-1.26; p-value <0.01; I2 = 0%), and had a higher Boston Bowel Preparation Scale (BBPS) score (MD, 0.31; 95% CI, 0.13-0.50; p-value <0.01; I2 = 81%). PEG was associated with more sleep disturbances (RR, 0.45; 95% CI, 0.25-0.82; p-value = 0.03; I2 = 0%). However, other adverse effects were similar between both solutions. Conclusion OSS demonstrated superior adenoma and polyp detection rates. When compared to PEG, patients utilizing OSS achieved higher BBPS scores. Data gleaned support enhanced cleansing efficacy and safety of OSS as a bowel preparation regimen.
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Affiliation(s)
- Umar Akram
- Department of MedicineAllama Iqbal Medical CollegeLahorePakistan
| | - Shahzaib Ahmed
- Department of MedicineFatima Memorial Hospital College of Medicine and DentistryLahorePakistan
| | - Eeshal Fatima
- Department of MedicineServices Institute of Medical SciencesLahorePakistan
| | - Eeman Ahmad
- Department of MedicineFatima Memorial Hospital College of Medicine and DentistryLahorePakistan
| | - Hamza Ashraf
- Department of MedicineAllama Iqbal Medical CollegeLahorePakistan
| | - Syed Adeel Hassan
- Division of Digestive Diseases and NutritionUniversity of KentuckyLexingtonUSA
| | - Zaheer Qureshi
- The Frank H. Netter M.D. School of Medicine at Quinnipiac UniversityBridgeportUSA
| | - Faryal Altaf
- Department of Internal MedicineIcahn School of Medicine at Mount Sinai/BronxCare Health SystemNew YorkUSA
| | - Daniel Buckles
- Division of Gastroenterology and HepatologyThe University of Kansas Medical CenterKansas CityUSA
| | - Javed Iqbal
- Nursing Department Hamad Medical CorporationDohaQatar
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Tamai N, Sumiyama K. Optimal bowel preparation for colonoscopy. Dig Endosc 2025; 37:139-146. [PMID: 39229776 DOI: 10.1111/den.14914] [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: 01/29/2024] [Accepted: 08/07/2024] [Indexed: 09/05/2024]
Abstract
There is robust evidence to indicate a strong correlation between the bowel preparation status and adenoma detection rate (ADR), which directly impacts the incidence and mortality rate of postcolonoscopy colorectal cancer. Therefore, improving bowel preparation has been of increasing interest. In Japan, commercially available bowel preparation agents include polyethylene glycol, oral sodium sulfate, sodium picosulfate-magnesium citrate, magnesium citrate, and oral sodium phosphate; each has its own strengths and limitations. The timing of administration can also influence the efficacy of bowel preparation and patient tolerability. Furthermore, meta-analyses have suggested predictive factors for inadequate bowel preparation. A detailed understanding of these factors could contribute to reducing the need for repeat colonoscopy within 1 year, as recommended for patients with inadequate bowel preparation. Recent advancements, such as oral sulfate tablets, present promising alternatives with higher patient satisfaction and ADRs than traditional methods. Achieving optimal bowel preparation requires enhanced instructions, individualized regimens, and a comprehensive understanding of patient backgrounds and the characteristics of various bowel preparation agents. This article provides a concise overview of the current status and advancements in bowel preparation for enhancing the quality and safety of colonoscopy.
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Affiliation(s)
- Naoto Tamai
- Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan
| | - Kazuki Sumiyama
- Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan
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Jung Y, Kim HG, Yang DH, Kang HW, Park JJ, Baek DH, Chun J, Gweon TG, Goong HJ, Kwak MS, Lee HJ, Park SK, Lee JH. Efficacy of Oral Sulfate Tablet and 2 L-Polyethylene Glycol With Ascorbic Acid for Bowel Preparation: A Prospective Randomized KASID Multicenter Trial. J Korean Med Sci 2024; 39:e301. [PMID: 39688329 DOI: 10.3346/jkms.2024.39.e301] [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: 06/04/2024] [Accepted: 09/02/2024] [Indexed: 12/18/2024] Open
Abstract
BACKGROUND Oral sulfate tablets (OSTs) are bowel preparation agents that combine oral sulfate solution and simethicone. This study compared the efficacy, tolerability, and safety of OST compared to 2 L-polyethylene glycol plus ascorbic acid (2 L-PEG/ASC). METHODS This prospective, randomized, controlled, single-blinded, multicenter, noninferiority trial enrolled 211 healthy adults who underwent colonoscopy between May 2020 and September 2022 at 13 university hospitals. The bowel cleansing rate was assessed using the Boston Bowel Preparation Scale (BBPS) and Harefield Cleansing Scale (HCS), and the preparation agents were administered in split regimens. RESULTS The total BBPS score (8.2 ± 1.5 vs. 7.8 ± 1.4, p = 0.040) and the high-quality bowel cleansing rates in the right colon (73.2% vs. 50.5), transverse colon (80.6% vs. 68.0%), and left colon (81.5% vs. 67.0%) on the BBPS were significantly higher in the OST group than in the 2 L-PEG/ASC group. However, the rates of successful cleansing according to BBPS (90.7% vs. 91.2%) and HCS (96.3% vs. 94.2%) did not significantly differ between the two groups. The taste, ease, and amount of consumption of the preparation agent; and willingness to repeat colonoscopy with the same agent (89.8% vs. 78.6%, P = 0.026) were significantly better in the OST group compared to the 2 L-PEG/ASC group. Adverse events and clinically significant laboratory changes were not significantly different between the two groups. CONCLUSION The OST was not inferior to 2 L-PEG/ASC in terms of bowel cleansing efficacy and showed better tolerability when used for bowel preparation for colonoscopy. TRIAL REGISTRATION Clinical Research Information Service Identifier: KCT0005017.
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Affiliation(s)
- Yunho Jung
- Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea
| | - Hyun Gun Kim
- Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
| | - Dong-Hoon Yang
- Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Hyoun Woo Kang
- Department of Gastroenterology, Seoul National University Boramae Medical Center, Seoul, Korea
| | - Jae Jun Park
- Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Dong Hoon Baek
- Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea
| | - Jaeyoung Chun
- Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Tae-Geun Gweon
- Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Hyeon Jeong Goong
- Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Min Seob Kwak
- Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea
| | - Hyun Jung Lee
- Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Soo-Kyung Park
- Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Jong Hoon Lee
- Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea
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Park JH, Kim M, Hong SW, Hwang SW, Park SH, Yang DH, Ye BD, Myung SJ, Yang SK, Byeon JS. Comparison of L L Polyethylene Glycol Plus Ascorbic Acid and Oral Sodium Sulfate Tablets for Colonoscopy Bowel Preparation. J Clin Med 2024; 13:7493. [PMID: 39685949 DOI: 10.3390/jcm13237493] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2024] [Revised: 12/03/2024] [Accepted: 12/06/2024] [Indexed: 12/18/2024] Open
Abstract
Background and Aims: A low-volume (1 L) polyethylene glycol plus ascorbic acid (PEG-A) solution and an oral sodium sulfate tablet (OST) formulation are recently introduced agents for colonoscopy bowel preparation. This study investigated the efficacy, safety, and tolerability of 1 L PEG-A vs. OST. Methods: This single-center, prospective, randomized, endoscopist-blinded study randomly assigned patients into 2 groups: 1 L PEG-A (group A); and OST (group B). Efficacy of bowel preparation was evaluated using the Boston Bowel Preparation Scale (BBPS). Tolerability and safety were investigated with a standardized questionnaire. Results: A total of 174 patients were included in the final analysis (group A, n = 92; group B, n = 82). Successful bowel preparation was achieved in 91.3% and 95.1% of patients in groups A and B, respectively (p = 0.324). Overall mean satisfaction with bowel preparation was greater among those in group B vs. those in group A (8.2 ± 1.7 vs. 6.8 ± 2.0, respectively; p < 0.001). Although abdominal distension was less common in group A than group B (3/92 [3.3%] vs. 9/82 [11.0%], respectively; p = 0.045), overall adverse events developed similarly in both groups (27/92 [29.3%] vs. 21/82 [25.6%], p = 0.583). In subgroup analysis of older patients (≥65 years of age), efficacy, overall satisfaction, and safety profiles were not different between groups A and B. Conclusions: Both 1 L PEG-A and OST demonstrated efficacy, tolerability, and safety for colonoscopy bowel preparation. OST was slightly better tolerated, whereas 1 L PEG-A resulted in less abdominal distension. Both agents were effective and safe in older patients.
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Affiliation(s)
- Jin Hwa Park
- Department of Gastroenterology, University of Hanyang College of Medicine, 222-1, Wangsimni-ro, Seongdong-gu, Seoul 04763, Republic of Korea
| | - Minjun Kim
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea
| | - Seung Wook Hong
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea
| | - Sung Wook Hwang
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea
| | - Sang Hyoung Park
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea
| | - Dong-Hoon Yang
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea
| | - Byong Duk Ye
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea
| | - Seung-Jae Myung
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea
| | - Suk-Kyun Yang
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea
| | - Jeong-Sik Byeon
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea
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Liu X, Yu W, Liu J, Liu Q. Oral sulfate solution versus polyethylene glycol for bowel preparation before colonoscopy, meta-analysis and trial sequential analysis of randomized clinical trials. Tech Coloproctol 2024; 28:99. [PMID: 39138737 DOI: 10.1007/s10151-024-02981-9] [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: 03/20/2024] [Accepted: 07/12/2024] [Indexed: 08/15/2024]
Abstract
BACKGROUND This study aimed to compare oral sulfate solution (OSS) with polyethylene glycol (PEG) for bowel preparation before colonoscopy. METHODS A literature search was performed on PubMed, Ovid, and Cochrane Databases for randomized clinical trials (RCT) comparing OSS with PEG for bowel preparation before colonoscopy. The last search was performed on 22 August 2023. The primary outcome was the quality of bowel preparation. The outcomes were compared by meta-analysis and trial sequential analysis (TSA). RESULTS A total of 14 RCTs with 4526 patients were included. OSS was comparable with PEG regarding adequate bowel preparation [P = 0.16, odds ratio (OR) = 1.19, 95% confidence interval (CI) [0.93, 1.51], I2 = 0%]. However, OSS showed obvious priority in excellent bowel preparation (P < 0.001, OR = 1.62, 95% CI [1.27, 2.05], I2 = 0%) and total Boston bowel preparation scale (BBPS) [P = 0.02, weighted mean difference (WMD) = 0.27, 95% CI [0.05, 0.50], I2 = 84%]. Additionally, the detection rate of polyps (P = 0.001, OR = 1.44, 95% CI [1.15, 1.80], I2 = 0%) and adenoma (P = 0.007, OR = 1.22, 95% CI [1.06, 1.42], I2 = 0%) was significantly higher in the OSS group. The two groups showed comparable incidence of adverse events except for a higher incidence of dizziness (P = 0.02, OR = 1.74, 95% CI [1.08, 2.83], I2 = 11%) was indicated in the OSS group. Moreover, OSS was associated with a higher satisfaction score (P = 0.02, WMD = 0.62, 95% CI [0.09, 1.15], I2 = 70%). In the TSA, the cumulative Z-curve crossed both the conventional boundary and trial sequential monitoring boundary and the required information size has been reached for excellent bowel preparation and total BBPS. CONCLUSION The current data demonstrated that OSS was associated with better quality of bowel preparation. More clinical trials are still needed to confirm other outcomes.
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Affiliation(s)
- X Liu
- Department of General Surgery, Jiujiang City Key Laboratory of Cell Therapy, Jiu Jiang No.1 People's Hospital, No. 48, Taling South Road, Jiujiang City, 332000, Jiangxi Province, China
| | - W Yu
- Department of General Surgery, Jiujiang City Key Laboratory of Cell Therapy, Jiu Jiang No.1 People's Hospital, No. 48, Taling South Road, Jiujiang City, 332000, Jiangxi Province, China
| | - J Liu
- Department of General Surgery, Jiujiang City Key Laboratory of Cell Therapy, Jiu Jiang No.1 People's Hospital, No. 48, Taling South Road, Jiujiang City, 332000, Jiangxi Province, China
| | - Q Liu
- Department of General Surgery, Jiujiang City Key Laboratory of Cell Therapy, Jiu Jiang No.1 People's Hospital, No. 48, Taling South Road, Jiujiang City, 332000, Jiangxi Province, China.
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Park JH, Hong SW, Hwang SW, Park SH, Yang DH, Ye BD, Myung SJ, Yang SK, Byeon JS. Efficacy and safety of oral sodium sulfate tablet compared with 1-L polyethylene glycol plus ascorbate: a prospective, randomized, endoscopist-blinded trial. J Gastroenterol Hepatol 2023; 38:2090-2096. [PMID: 37655723 DOI: 10.1111/jgh.16343] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/27/2023] [Revised: 08/16/2023] [Accepted: 08/18/2023] [Indexed: 09/02/2023]
Abstract
BACKGROUND AND AIM Low-volume bowel preparation solutions, including 1-L polyethylene glycol plus ascorbate (PEG-A), have been developed to improve tolerability. The oral sodium sulfate tablet (OST) is a new agent with simethicone as a preloaded component. We investigated the efficacy, safety, and tolerability of OST compared to 1-L PEG-A. METHODS A single-center, prospective, controlled study was performed with randomization into the OST (group A) and 1-L PEG-A (group B) groups. Bowel preparation efficacy was assessed on the Boston Bowel Preparation Scale (BBPS) and Bubble Scale. Safety and tolerability were evaluated using a questionnaire and laboratory examination. RESULTS Final analysis was performed on 171 patients (group A: 87, group B: 84). The proportion of bowel preparation success (BBPS ≥ 2 for each colonic segment) in group A was not inferior compared to group B (95.4% vs 96.4%, P = 0.736, 1-sided 97.5% lower confidence limit -7.0%). The adenoma detection rate was not different (59.6% vs 41.9%; P = 0.087). The bubble scale was better in group A (0.2 ± 0.9 vs 1.9 ± 1.7, P < 0.001). All adverse events were mild in both groups. Nausea was less frequent in group A (14.9% vs 38.1%, P = 0.001). Overall satisfaction was better in group A (8.1 ± 2.1 vs 6.4 ± 2.8, P < 0.001). No clinically significant laboratory abnormality developed in both groups. These findings were similarly shown in old patients ≥65 years. CONCLUSIONS Both OST and 1-L PEG-A were efficacious, safe, and tolerable for bowel preparation of colonoscopy. The OST showed fewer bubbles and slightly better tolerability.
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Affiliation(s)
- Jin Hwa Park
- Department of Gastroenterology, University of Hanyang College of Medicine, Seoul, South Korea
| | - Seung Wook Hong
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
| | - Sung Wook Hwang
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
| | - Sang Hyoung Park
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
| | - Dong-Hoon Yang
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
| | - Byong Duk Ye
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
| | - Seung-Jae Myung
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
| | - Suk-Kyun Yang
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
| | - Jeong-Sik Byeon
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
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Pan P, Zhao S, Wang S, Song Y, Gu L, Chen Y, Zhao J, Lu L, Li X, Xu H, Liu G, Li Y, Xu L, Wang J, Li Z, Bai Y. Comparison of the efficacy and safety of an oral sulfate solution and 3-L polyethylene glycol on bowel preparation before colonoscopy: a phase III multicenter randomized controlled trial. Gastrointest Endosc 2023; 98:977-986.e14. [PMID: 37422241 DOI: 10.1016/j.gie.2023.06.070] [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: 03/15/2023] [Revised: 06/09/2023] [Accepted: 06/29/2023] [Indexed: 07/10/2023]
Abstract
BACKGROUND AND AIMS Adequate bowel preparation is crucial for clear mucosal visualization during colonoscopy. We aimed to comprehensively compare oral sulfate solution (OSS) and 3-L split-dose polyethylene glycol (PEG) for bowel preparation before colonoscopy. METHODS This randomized, active-controlled, noninferiority study was performed in 10 medical centers. Eligible subjects were enrolled to receive OSS or 3-L PEG in a split-dose regimen. The quality of bowel preparation, adverse reactions, and acceptability were evaluated. The quality of bowel preparation was evaluated using the Boston Bowel Preparation Scale. Safety was evaluated by adverse reactions. The study population was divided into the full analysis set (FAS), the safety set, the modified FAS (mFAS), and the per-protocol set (PPS). RESULTS Three hundred forty-eight potentially eligible subjects were enrolled. Three hundred forty-four subjects were included in the FAS and safety set, 340 subjects were included in the mFAS, and 328 subjects were included in the PPS. Adequate bowel preparation of the OSS was not inferior to 3-L PEG in the mFAS (98.22% vs 97.66%) and the PPS (98.17% vs 98.78%). There was no significant difference in acceptability between the 2 groups (94.74% vs 94.80%, P = .9798). Overall adverse reactions were similar (50.88% vs 44.51%, P = .2370) between the 2 groups. CONCLUSIONS The split-dose OSS regimen was not inferior to the split-dose 3-L PEG regimen for the quality of bowel preparation in a Chinese adult population. The safety and acceptability of the 2 groups were similar. (Clinical trial registration number: NCT05465889.).
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Affiliation(s)
- Peng Pan
- Department of Gastroenterology, Changhai Hospital, Naval Military Medical University, Shanghai, China
| | - Shengbing Zhao
- Department of Gastroenterology, Changhai Hospital, Naval Military Medical University, Shanghai, China
| | - Shuling Wang
- Department of Gastroenterology, Changhai Hospital, Naval Military Medical University, Shanghai, China
| | - Yihang Song
- Department of Gastroenterology, Changhai Hospital, Naval Military Medical University, Shanghai, China
| | - Lun Gu
- Department of Gastroenterology, Changhai Hospital, Naval Military Medical University, Shanghai, China
| | - Youxiang Chen
- Department of Gastroenterology, the First Affiliated Hospital, Nanchang University, Nanchang, China
| | - Jiangrong Zhao
- Department of Gastroenterology, Shanghai Integrative Medicine Hospital, Shanghai, China
| | - Lungen Lu
- Department of Gastroenterology, Shanghai First People's Hospital, Shanghai, China
| | - Xiuling Li
- Department of Gastroenterology, Henan Provincial People's Hospital, Zhengzhou, China
| | - Hongzhi Xu
- Department of Gastroenterology, Zhongshan Hospital of Xiamen University, Xiamen, China
| | - Gaifang Liu
- Department of Gastroenterology, Hebei Provincial People's Hospital, Shijiazhuang, China
| | - Yanqing Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, China
| | - Le Xu
- Department of Gastroenterology, Beijing Hospital, Beijing, China
| | - Jiangbin Wang
- Department of Gastroenterology, China-Japan Union Hospital of Jilin University, Jilin, China
| | - Zhaoshen Li
- Department of Gastroenterology, Changhai Hospital, Naval Military Medical University, Shanghai, China
| | - Yu Bai
- Department of Gastroenterology, Changhai Hospital, Naval Military Medical University, Shanghai, China
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Lim KY, Kim KO, Kim EY, Lee YJ, Jang BI, Kim SK, Yang CH. Efficacy and safety of 1 L polyethylene glycol plus ascorbic acid for bowel preparation in elderly: comparison with oral sulfate solution. Korean J Intern Med 2023; 38:651-660. [PMID: 37482653 PMCID: PMC10493436 DOI: 10.3904/kjim.2023.030] [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: 01/20/2023] [Revised: 04/13/2023] [Accepted: 04/25/2023] [Indexed: 07/25/2023] Open
Abstract
BACKGROUND/AIMS Recently, 1 L of polyethylene glycol (PEG) plus ascorbic acid (Asc) has been introduced in Korea as a colonoscopy preparation agent. Data on its efficacy and safety in older adults have been limited. We aimed to evaluate the safety and efficacy of 1 L PEG/Asc in older adults by comparing it with oral sulfate solution (OSS). METHODS A prospective multicenter randomized study was conducted with subjects aged ≥ 65 years who underwent colonoscopy. The participants were randomized to receive 1 L PEG/Asc or OSS. The primary endpoint was successful bowel preparation, defined as total Boston Bowel Preparation Scale ≥ 6, and ≥ 2 at each segment. Patient satisfaction, adverse events, and renal function changes were compared between the groups. RESULTS Among the 106 patients, 104 were finally included in the analysis. Overall, successful bowel preparation was achieved in 96.2% of both 1 L PEG/Asc and OSS groups. The satisfaction scores for taste, total amount ingested, overall feeling, and willingness to repeat the same regimen were not significantly different between the groups. Adverse events of moderate or higher severity occurred in 16 and 10 cases in the 1 L PEG/Asc and OSS group, respectively. There were no significant changes in electrolyte levels or renal function from baseline. CONCLUSION The successful bowel preparation rate was > 90% in both groups without severe adverse effects and significant changes in renal function. As a new low-dose preparation regimen for colonoscopy in older adults, 1 L PEG/Asc, is as effective and safe as OSS.
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Affiliation(s)
- Ki Young Lim
- Department of Internal Medicine, Yeungnam University College of Medicine, Daegu,
Korea
| | - Kyeong Ok Kim
- Department of Internal Medicine, Yeungnam University College of Medicine, Daegu,
Korea
| | - Eun Young Kim
- Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu,
Korea
| | - Yoo Jin Lee
- Department of Internal Medicine, Keimyung University School of Medicine, Daegu,
Korea
| | - Byung Ik Jang
- Department of Internal Medicine, Yeungnam University College of Medicine, Daegu,
Korea
| | - Sung Kook Kim
- Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu,
Korea
| | - Chang Heon Yang
- Health Promotion Center, Yeungnam University College of Medicine, Daegu,
Korea
- Deparment of Internal Medicine, Dongguk University School of Medicine, Gyeongju,
Korea
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Lee JM, Lee KM, Kang HS, Koo JS, Lee HS, Jeong SH, Kim JH, Kim DB. Oral Sulfate Solution Is as Effective as Polyethylene Glycol with Ascorbic Acid in a Split Method for Bowel Preparation in Patients with Inactive Ulcerative Colitis: A Randomized, Multicenter, and Single-Blind Clinical Trial. Gut Liver 2023; 17:591-599. [PMID: 36588527 PMCID: PMC10352068 DOI: 10.5009/gnl220202] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/16/2022] [Revised: 08/23/2022] [Accepted: 10/07/2022] [Indexed: 01/03/2023] Open
Abstract
Background/Aims Low-volume preparations for colonoscopy are gaining attention for their higher acceptability. However, the efficacy and safety of oral sulfate solution (OSS) preparations in patients with ulcerative colitis (UC) has not been well known. Therefore, we aimed to compare OSS and 2-L polyethylene glycol with ascorbic acid (PEG+Asc) for bowel preparation in inactive UC. Methods A multicenter, randomized, single-blind study was conducted at six tertiary referral hospitals in Korea. Outpatients with UC who had stable disease activity were randomly allocated to the OSS group or the 2-L PEG+Asc group for bowel preparation before colonoscopy. The study outcomes included treatment efficacy, safety, tolerability, and acceptability. Bowel cleansing was assessed using the Boston Bowel Preparation Scale and rated as successful cleansing if the score was ≥6. Patient acceptance and tolerability were assessed using a 4-point ordinal scale. Additionally, disease activity and laboratory data before and after colonoscopy were evaluated to check for safety. Results The OSS and 2-L PEG+Asc groups included 92 and 93 participants, respectively. No significant between-group difference was noted in successful cleansing (OSS [96.7%] vs 2-L PEG+Asc [97.8%], p=0.64). Moreover, the safety, acceptance, and tolerability were not significantly different (all p>0.05). Furthermore, no significant changes were found in serum electrolytes or disease activity in either group. Conclusions OSS is effective for colonoscopy cleansing, has acceptable tolerability, and does not affect disease activity; thus, it can be used safely for bowel preparation in patients with inactive UC.
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Affiliation(s)
- Ji Min Lee
- Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Kang-Moon Lee
- Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Ho Suk Kang
- Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea
| | - Ja Seol Koo
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea
| | - Hyun Seok Lee
- Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea
| | - Seok-Hoo Jeong
- Division of Gastroenterology, Department of Internal Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Korea
| | - Jung Ho Kim
- Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea
| | - Dae Bum Kim
- Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
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10
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Sun M, Yang G, Wang Y. Cleaning effect and tolerance of 16 bowel preparation regimens on adult patients before colonoscopy: a network meta-analysis. Int J Colorectal Dis 2023; 38:69. [PMID: 36905434 DOI: 10.1007/s00384-023-04355-3] [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: 02/20/2023] [Indexed: 03/12/2023]
Abstract
PURPOSE Colonoscopy is the gold standard for the diagnosis of colorectal cancer (CRC). Before a colonoscopy, an adequate bowel preparation (BP) is required. Currently, more novel regimens with different effects have been proposed and used successively. This network meta-analysis aims to compare the cleaning effects and patients' tolerability of several BP regimens. METHODS We performed a network meta-analysis of randomized controlled trials including sixteen kinds of BP regimens. We searched PubMed, Cochrane Library, Embase, and Web of Science databases. The outcomes of this study were bowel cleansing effect and tolerance. RESULTS We included a total of 40 articles with 13,064 patients. For the primary outcomes, polyethylene glycol (PEG) + ascorbic acid (Asc) + simethicone (Sim) (OR, 14.27, 95%CrI, 2.68-127.87) regimen is ranked first in Boston Bowel Preparation Scale (BBPS). PEG + Sim (OR, 2.0, 95%CrI 0.64-6.4) regimen is ranked first in Ottawa Bowel Preparation Scale (OBPS), but without significant differences. For the secondary outcomes, PEG + Sodium Picosulfate/Magnesium Citrate (SP/MC) (OR, 4.88e + 11, 95%CrI, 39.56-1.82e + 35) regimen is the best in cecal intubation rate(CIR). PEG + Sim (OR,1.5, 95%CrI, 1.0-2.2) regimen is ranked first in adenoma detection rate(ADR). Senna (OR, 3.23, 95%CrI, 1.04-9.97) and SP/MC (OR, 249.91, 95%CrI, 78.49-958.19) regimens are ranked first in abdominal pain and willingness to repeat, respectively. There is no significant difference in cecal intubation time (CIT), polyp detection rate (PDR), nausea, vomiting, and abdominal bloat. CONCLUSION PEG + Asc + Sim regimen is more effective at cleaning the bowel. PEG + SP/MC will be helpful to increase CIR. For ADR, PEG + Sim regimen will be more helpful. In addition, PEG + Asc + Sim is the least likely to cause abdominal bloat, while Senna regimen is more likely to cause abdominal pain. Patients prefer to re-use the SP/MC regimen for bowel preparation.
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Affiliation(s)
- Ming Sun
- College of Life Sciences and Biopharmaceuticals, Shenyang Pharmaceutical University, Shenyang, China
- Pharmacy Department of Chinese PLA No. 463 Hospital, Shenyang, China
| | - Guangzhao Yang
- Department of Outpatient, General Hospital of Northern Theater Command, Shenyang, China
| | - Yu Wang
- College of Life Sciences and Biopharmaceuticals, Shenyang Pharmaceutical University, Shenyang, China.
- Pharmacy Department of Chinese PLA No. 463 Hospital, Shenyang, China.
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11
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Song JH, Bae JH, Yim JY. Efficacy of oral sulfate tablets for bowel preparation and adenoma detection rate. J Gastroenterol Hepatol 2023; 38:410-415. [PMID: 36453642 DOI: 10.1111/jgh.16079] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/07/2022] [Revised: 10/25/2022] [Accepted: 11/21/2022] [Indexed: 12/03/2022]
Abstract
BACKGROUND AND AIM The adenoma detection rate (ADR), which is closely related to bowel preparation, is the most important factor for colonoscopy quality assessment. New oral sulfate tablets (OSTs) have been developed to improve bowel preparation compliance. This study evaluated the efficacy of OSTs in terms of the ADR and bowel preparation status. METHODS Medical records of subjects under the age of 65 who underwent colonoscopy from March 2019 to February 2021 were retrospectively reviewed. Polyethylene glycol with ascorbic acid (PEG-A) was used as a bowel preparation for the first half of the study period, and OSTs were used for the second half. In total, 16 971 subjects were included in the study: 9199 (54.2%) used PEG-A, and 7772 (45.8%) used OSTs. Bowel cleansing quality was assessed by the Boston Bowel Preparation Scale (BBPS). RESULTS The average age was 50 years. The rate of adequate bowel preparation was higher in the OST group than in the PEG-A group (97.2% vs 95.0%, P < 0.001). The mean BBPS was also higher in the OST group (8.02 vs 7.75, P < 0.001). The adenomas per colonoscopy (APC), the ADR and the sessile serrated polyp detection rate (SSPDR) were higher in the OST group than in the PEG-A group (APC 0.56 ± 1.01 vs 0.48 ± 0.91, P < 0.001; ADR 34.5% vs 30.7%, P < 0.001; SSPDR 5.2% vs 3.3%, P < 0.001). CONCLUSIONS Compared with PEG-A, OSTs yielded superior APC, ADRs, SSPDRs, and better bowel cleanliness. Therefore, OSTs are a good alternative for patients who have difficulty taking large-volume bowel preparation formulations.
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Affiliation(s)
- Ji Hyun Song
- Department of Internal Medicine, Healthcare Research Institute, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, South Korea
| | - Jung Ho Bae
- Department of Internal Medicine, Healthcare Research Institute, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, South Korea
| | - Jeong Yoon Yim
- Department of Internal Medicine, Healthcare Research Institute, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, South Korea
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12
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Ge F, Kang X, Wang Z, Zhu H, Liao L, Wang M, Jia J, Lou L, Guo X, Pan Y, Wan J. Low-dose of magnesium sulfate solution was not inferior to standard regime of polyethylene glycol for bowel preparation in elderly patients: a randomized, controlled study. Scand J Gastroenterol 2023; 58:94-100. [PMID: 35920250 DOI: 10.1080/00365521.2022.2106154] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
BACKGROUND Large polyethylene glycol (PEG) is a standard regimen for bowel preparation. However, elderly patients suffered from adverse events. This study was to compare the efficacy and safety of oral magnesium sulfate solution (MSS) vs standard PEG in elderly patients undergoing colonoscopy. METHODS Elderly patients aged 60-90 years, from two endoscopic centers, were enrolled in China. Patients were randomized to take a low dose of MSS or a standard PEG regime in a split-dose regime. The primary endpoint was the proportion of patients with adequate bowel preparation, which was defined as the total Boston Bowel Preparation Scale (BBPS) ≥6 and each segmental BBPS was ≥2. Secondary outcomes included adenoma detection rate (ADR), safety, adverse events, cecal intubation rate, willingness to repeat BP, and so on. RESULTS 1174 elderly patients were randomly allocated to the MSS group (n = 588) or the standard group (n = 586). Adequate BP was achieved in 94.0% of patients in the MSS group and 92.5% in the control (p = .287). ADR was also comparable between the two groups (43.0% and 39.9%, p = .282). Compared with the standard group, MSS group reported less abdominal discomfort (1.7% vs 6.0%), less nausea (13.6% vs 21.0%) and vomiting (1.2% vs 4.2%). The change in serum potassium levels after preparation in the standard group was significantly lower than that in the MSS group (-0.19 ± 0.08 vs -0.41 ± 0.11, p = .037). CONCLUSIONS Low dose of MSS was not inferior to the standard PEG regime in terms of bowel preparation quality for elderly patients. Low-dose MSS offered fewer adverse events and better tolerability. It is a preferable choice for the elderly to undergo bowel preparation for colonoscopy. CLINICAL TRIAL REGISTRATION NUMBER NCT04948567.
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Affiliation(s)
- Fulin Ge
- Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital, Beijing, China
| | - Xiaoyu Kang
- State key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Zeyu Wang
- State key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Hailan Zhu
- Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital, Beijing, China
| | - Liang Liao
- Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital, Beijing, China
| | - Ming Wang
- Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital, Beijing, China
| | - Jianjun Jia
- Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital, Beijing, China
| | - Lijun Lou
- State key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Xuegang Guo
- State key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Yanglin Pan
- State key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Jun Wan
- Department of Gastroenterology, The Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital, Beijing, China
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13
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Chen C, Shi M, Liao Z, Chen W, Wu Y, Tian X. Oral sulfate solution benefits polyp and adenoma detection during colonoscopy: Meta-analysis of randomized controlled trials. Dig Endosc 2022; 34:1121-1133. [PMID: 35294782 PMCID: PMC9545996 DOI: 10.1111/den.14299] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/07/2022] [Revised: 03/07/2022] [Accepted: 03/14/2022] [Indexed: 01/10/2023]
Abstract
OBJECTIVES Although oral sulfate solution (OSS) has been revealed to be not only safe and efficacious but also noninferior to polyethylene glycol with ascorbic acid (PEG + ASC), it is unclear whether OSS can ultimately increase the polyp detection rate (PDR) and adenoma detection rate (ADR). We performed this meta-analysis to estimate the effect of OSS on PDR and ADR during colonoscopy. METHODS We searched PubMed, EMBASE, and the Cochrane Library to identify relevant randomized controlled trials (RCTs) investigating the comparative effect of OSS versus PEG + ASC on the PDR and ADR during colonoscopy. Cecal intubation time (CIT), cecal intubation rate (CIR), and bowel preparation score were also evaluated. Review Manager (RevMan) version 5.3.0 was used to perform statistical analysis. RESULTS Eight RCTs involving 2059 patients fulfilled the selection criteria. Meta-analysis suggested that OSS significantly increased the PDR (47.34% vs. 40.14%, risk ratio [RR] 1.13, 95% confidence interval [CI] 1.03-1.24, P = 0.01) and ADR (44.60% vs. 38.14%, RR 1.17, 95% CI 1.03-1.33, P = 0.01) during colonoscopy. Subgroup analysis showed that the beneficial effects of OSS on PDR and ADR were consistent among patients with mean age >55 years and with body mass index <25 kg/m2 receiving outpatient colonoscopy, morning colonoscopy, and the 2-L bowel preparation protocol. Meanwhile, patients receiving OSS had a beneficial bowel preparation score. CONCLUSION Compared with polyethylene glycol-based regimens, the OSS bowel preparation regimen significantly increased the PDR and ADR in patients undergoing colonoscopy.
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Affiliation(s)
- Cheng Chen
- Department of Gastroenterology, Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized TreatmentChongqing University Cancer HospitalChongqingChina
| | - Mengyang Shi
- Department of Gastroenterology, Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized TreatmentChongqing University Cancer HospitalChongqingChina
| | - Zhongli Liao
- Department of Gastroenterology, Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized TreatmentChongqing University Cancer HospitalChongqingChina
| | - Weiqing Chen
- Department of Gastroenterology, Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized TreatmentChongqing University Cancer HospitalChongqingChina
| | - Yongzhong Wu
- Radiation Oncology CenterChongqing University Cancer HospitalChongqingChina
| | - Xu Tian
- Nursing DepartmentUniversitat Rovira I VirgiliTarragonaSpain
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14
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Auriemma F, Sferrazza S, Bianchetti M, Savarese MF, Lamonaca L, Paduano D, Piazza N, Giuffrida E, Mete LS, Tucci A, Milluzzo SM, Iannelli C, Repici A, Mangiavillano B. From advanced diagnosis to advanced resection in early neoplastic colorectal lesions: Never-ending and trending topics in the 2020s. World J Gastrointest Surg 2022; 14:632-655. [PMID: 36158280 PMCID: PMC9353749 DOI: 10.4240/wjgs.v14.i7.632] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/07/2021] [Revised: 05/02/2021] [Accepted: 06/20/2022] [Indexed: 02/06/2023] Open
Abstract
Colonoscopy represents the most widespread and effective tool for the prevention and treatment of early stage preneoplastic and neoplastic lesions in the panorama of cancer screening. In the world there are different approaches to the topic of colorectal cancer prevention and screening: different starting ages (45-50 years); different initial screening tools such as fecal occult blood with immunohistochemical or immune-enzymatic tests; recto-sigmoidoscopy; and colonoscopy. The key aspects of this scenario are composed of a proper bowel preparation that ensures a valid diagnostic examination, experienced endoscopist in detection of preneoplastic and early neoplastic lesions and open-minded to upcoming artificial intelligence-aided examination, knowledge in the field of resection of these lesions (from cold-snaring, through endoscopic mucosal resection and endoscopic submucosal dissection, up to advanced tools), and management of complications.
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Affiliation(s)
- Francesco Auriemma
- Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza 21053, Italy
| | - Sandro Sferrazza
- Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, Trento 38014, Italy
| | - Mario Bianchetti
- Digestive Endoscopy Unit, San Giuseppe Hospital - Multimedica, Milan 20123, Italy
| | - Maria Flavia Savarese
- Department of Gastroenterology and Gastrointestinal Endoscopy, General Hospital, Sanremo 18038, Italy
| | - Laura Lamonaca
- Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza 21053, Italy
| | - Danilo Paduano
- Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza 21053, Italy
| | - Nicole Piazza
- Gastroenterology Unit, IRCCS Policlinico San Donato, San Donato Milanese; Department of Biomedical Sciences for Health, University of Milan, Milan 20122, Italy
| | - Enrica Giuffrida
- Gastroenterology and Hepatology Unit, A.O.U. Policlinico “G. Giaccone", Palermo 90127, Italy
| | - Lupe Sanchez Mete
- Department of Gastroenterology and Digestive Endoscopy, IRCCS Regina Elena National Cancer Institute, Rome 00144, Italy
| | - Alessandra Tucci
- Department of Gastroenterology, Molinette Hospital, Città della salute e della Scienza di Torino, Turin 10126, Italy
| | | | - Chiara Iannelli
- Department of Health Sciences, Magna Graecia University, Catanzaro 88100, Italy
| | - Alessandro Repici
- Digestive Endoscopy Unit and Gastroenterology, Humanitas Clinical and Research Center and Humanitas University, Rozzano 20089, Italy
| | - Benedetto Mangiavillano
- Biomedical Science, Hunimed, Pieve Emanuele 20090, Italy
- Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza, Varese 21053, Italy
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15
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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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16
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Di Leo M, Iannone A, Arena M, Losurdo G, Palamara MA, Iabichino G, Consolo P, Rendina M, Luigiano C, Di Leo A. Novel frontiers of agents for bowel cleansing for colonoscopy. World J Gastroenterol 2021; 27:7748-7770. [PMID: 34963739 PMCID: PMC8661374 DOI: 10.3748/wjg.v27.i45.7748] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/17/2021] [Revised: 04/23/2021] [Accepted: 11/24/2021] [Indexed: 02/06/2023] Open
Abstract
The incidence of colorectal cancer (CRC) is characterized by rapid declines in the wake of widespread screening. Colonoscopy is the gold standard for CRC screening, but its accuracy is related to high quality of bowel preparation (BP). In this review, we aimed to summarized the current strategy to increase bowel cleansing before colonoscopy. Newly bowel cleansing agents were developed with the same efficacy of previous agent but requiring less amount of liquid to improve patients' acceptability. The role of the diet before colonoscopy was also changed, as well the contribution of educational intervention and the use of adjunctive drugs to improve patients' tolerance and/or quality of BP. The review also described BP in special situations, as lower gastrointestinal bleeding, elderly people, patients with chronic kidney disease, patients with inflammatory bowel disease, patients with congestive heart failure, inpatient, patient with previous bowel resection, pregnant/lactating patients. The review underlined the quality of BP should be described using a validate scale in colonoscopy report and it explored the available scales. Finally, the review explored the possible contribution of bowel cleansing in post-colonoscopy syndrome that can be related by a transient alteration of gut microbiota. Moreover, the study underlined several points needed to further investigations.
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Affiliation(s)
- Milena Di Leo
- Unit of Digestive Endoscopy, San Paolo Hospital, Milan 20090, Italy
| | - Andrea Iannone
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari 70124, Italy
| | - Monica Arena
- Unit of Digestive Endoscopy, San Paolo Hospital, Milan 20090, Italy
| | - Giuseppe Losurdo
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari 70124, Italy
| | | | | | - Pierluigi Consolo
- Unit of Digestive Endoscopy, University of Messina, Hospital "G. Martino", Messina 98121, Italy
| | - Maria Rendina
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari 70124, Italy
| | - Carmelo Luigiano
- Unit of Digestive Endoscopy, San Paolo Hospital, Milan 20090, Italy
| | - Alfredo Di Leo
- Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari 70124, Italy
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Spadaccini M, Frazzoni L, Vanella G, East J, Radaelli F, Spada C, Fuccio L, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Gralnek I, Jover R, Kaminski MF, Pellisé M, Triantafyllou K, Van Hooft JE, Dumonceau JM, Marmo C, Alfieri S, Chandrasekar VT, Sharma P, Rex DK, Repici A, Hassan C. Efficacy and Tolerability of High- vs Low-Volume Split-Dose Bowel Cleansing Regimens for Colonoscopy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol 2020; 18:1454-1465.e14. [PMID: 31683057 DOI: 10.1016/j.cgh.2019.10.044] [Citation(s) in RCA: 47] [Impact Index Per Article: 9.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/09/2019] [Revised: 10/17/2019] [Accepted: 10/25/2019] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Efficacy of bowel preparation is an important determinant of outcomes of colonoscopy. It is not clear whether approved low-volume polyethylene glycol (PEG) and non-PEG regimens are as effective as high-volume PEG regimens when taken in a split dose. METHODS In a systematic review of multiple electronic databases through January 31, 2019 with a registered protocol (PROSPERO: CRD42019128067), we identified randomized controlled trials that compared low- vs high-volume bowel cleansing regimens, administered in a split dose, for colonoscopy. The primary efficacy outcome was rate of adequate bowel cleansing, and the secondary efficacy outcome was adenoma detection rate. Primary tolerability outcomes were compliance, tolerability, and willingness to repeat. We calculated relative risk (RR) and 95% CI values and assessed heterogeneity among studies by using the I2 statistic. The overall quality of evidence was assessed using the GRADE framework. RESULTS In an analysis of data from 17 randomized controlled trials, comprising 7528 patients, we found no significant differences in adequacy of bowel cleansing between the low- vs high-volume split-dose regimens (86.1% vs 87.4%; RR, 1.00; 95% CI, 0.98-1.02) and there was minimal heterogeneity (I2 = 17%). There was no significant difference in adenoma detection rate (RR, 0.96; 95% CI, 0.87-1.08) among 4 randomized controlled trials. Compared with high-volume, split-dose regimens, low-volume split-dose regimens had higher odds for compliance or completion (RR, 1.06; 95% CI, 1.02-1.10), tolerability (RR, 1.39; 95% CI, 1.12-1.74), and willingness to repeat bowel preparation (RR, 1.41; 95% CI, 1.20-1.66). The overall quality of evidence was moderate. CONCLUSIONS Based on a systematic review of 17 randomized controlled trials, low-volume, split-dose regimens appear to be as effective as high-volume, split-dose regimens in bowel cleansing and are better tolerated, with superior compliance.
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Affiliation(s)
| | - Leonardo Frazzoni
- Gastroenterology Unit, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy
| | - Giuseppe Vanella
- Endoscopy Unit, Sant'Andrea University Hospital, "Sapienza" University of Rome, Rome, Italy
| | - James East
- Translational Gastroenterology Unit, John Radcliffe Hospital, University of Oxford, and Oxford NIHR Biomedical Research Centre, Oxford, United Kingdom
| | | | - Cristiano Spada
- Digestive Endoscopy Unit, Fondazione Poliambulanza, Brescia, Italy
| | - Lorenzo Fuccio
- Gastroenterology Unit, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy
| | | | - Raf Bisschops
- Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium
| | - Michael Bretthauer
- Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium; Institute of Health and Society, University of Oslo Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway
| | - Evelien Dekker
- Department of Gastroenterology and Hepatology Amsterdam University Medical Centers, Amsterdam, the Netherlands
| | | | - Monika Ferlitsch
- Department of Internal Medicine III, Division of Gastroenterology & Hepatology, Medical University of Vienna, Austria
| | - Ian Gralnek
- Institute of Gastroenterology and Hepatology Emek Medical Center, Afula, Israel
| | - Rodrigo Jover
- Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel; Servicio de Medicina Digestiva, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria ISABIAL, Alicante, Spain
| | - Michal F Kaminski
- Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland
| | - Maria Pellisé
- Gastroenterology Department, Institut de Malalties Digestives i Metabòliques, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain
| | - Konstantinos Triantafyllou
- Ηepatogastroenterology Unit, Second Department of Internal Medicine and Research Institute, Athens University, Athens, Greece
| | - Jeanin E Van Hooft
- Department of Gastroenterology and Hepatology Amsterdam University Medical Centers, Amsterdam, the Netherlands
| | | | - Clelia Marmo
- Division of Surgical Digestive System, University Hospital Second University of Naples, Naples, Italy
| | - Sergio Alfieri
- Fondazione Policlinico A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
| | | | - Prateek Sharma
- Kansas City Veterans Affairs Hospital, Kansas City, Missouri
| | - Doug K Rex
- Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, Indiana
| | | | - Cesare Hassan
- Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy
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Millien VO, Mansour NM. Bowel Preparation for Colonoscopy in 2020: A Look at the Past, Present, and Future. Curr Gastroenterol Rep 2020; 22:28. [PMID: 32377915 DOI: 10.1007/s11894-020-00764-4] [Citation(s) in RCA: 66] [Impact Index Per Article: 13.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
PURPOSE OF THIS REVIEW Colorectal cancer is the third most common cancer in the USA. Colonoscopy is considered the gold standard for colorectal cancer screening and can offer both diagnosis and therapy. The bowel preparation remains a significant barrier for patients who need to undergo colonoscopy and is often cited as the most dreaded aspect of the colonoscopy process. Inadequate bowel preparations still occur in 10-25% of colonoscopies, and this in turn can lead to increased procedural times, lower cecal intubation rates, and shorter interval between colonoscopies. From a quality standpoint, it is imperative that we do what we can to decrease the rate of inadequate bowel preparations. This review will focus on recent data regarding bowel preparation and offers a glimpse into what may be coming in the future. RECENT FINDINGS Recent advances in the field have been made to improve tolerability of bowel preparations and allow for more adequate colonoscopies. Newer, lower volume, flavored preparations, the use of adjuncts, and using split-dose preparations all can help with tolerability, compliance, and, in turn, preparation quality. Edible bowel preparations may become available in the near future. Early data on the use of artificial intelligence for assessment of preparation quality has been promising. Additionally, utilization of smartphone technology for education prior to the bowel preparation has also been shown to improve the adequacy of bowel preparations. CONCLUSIONS Ongoing efforts to improve the tolerability and palatability of colonoscopy bowel preparations are important from a quality improvement standpoint to ensure the adequacy of colonoscopy. Incorporating patient-specific factors and comorbidities is also an essential aspect of improving the quality of bowel preparation. Leveraging technology to better communicate with and educate patients on the bowel preparation process is likely to play a larger role in the coming years.
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Affiliation(s)
- Valentine Ongeri Millien
- Section of Gastroenterology and Hepatology, Baylor College of Medicine, 7200 Cambridge St., Suite 8B, Houston, TX, 77030, USA
| | - Nabil M Mansour
- Section of Gastroenterology and Hepatology, Baylor College of Medicine, 7200 Cambridge St., Suite 8B, Houston, TX, 77030, USA.
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Sharma P, Burke CA, Johnson DA, Cash BD. The importance of colonoscopy bowel preparation for the detection of colorectal lesions and colorectal cancer prevention. Endosc Int Open 2020; 8:E673-E683. [PMID: 32355887 PMCID: PMC7165013 DOI: 10.1055/a-1127-3144] [Citation(s) in RCA: 30] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/04/2019] [Accepted: 12/31/2019] [Indexed: 12/11/2022] Open
Abstract
Background and study aims Colonoscopy for colorectal cancer (CRC) screening has reduced CRC incidence and mortality and improved prognosis. Optimal bowel preparation and high-quality endoscopic technique facilitate early CRC detection. This review provides a narrative on the clinical importance of bowel preparation for colonoscopy and highlights available bowel preparations. Methods A PubMed search was conducted through June 2019 to identify studies evaluating clinical outcomes, efficacy, safety, and tolerability associated with bowel preparation for CRC screening-related colonoscopy. Results Selecting the optimal bowel preparation regimen is based on considerations of efficacy, safety, and tolerability, in conjunction with individual patient characteristics and preferences. Available bowel preparations include high-volume (4 L) and low-volume (2 L and 1 L), polyethylene glycol (PEG) solutions, sodium sulfate, sodium picosulfate/magnesium oxide plus anhydrous citric acid, sodium phosphate tablets, and the over-the-counter preparations magnesium citrate and PEG-3350. These preparations may be administered as a single dose on the same day or evening before, or as two doses administered the same day or evening before/morning of colonoscopy. Ingesting at least half the bowel preparation on the day of colonoscopy (split-dosing) is associated with higher adequate bowel preparation quality versus evening-before dosing (odds ratio [OR], 2.5; 95 % confidence interval [CI], 1.9-3.4). Conclusions High-quality bowel preparation is integral for optimal CRC screening/surveillance by colonoscopy. Over the last 30 years, patients and providers have gained more options for bowel preparation, including low-volume agents with enhanced tolerability and cleansing quality that are equivalent to 4 L preparations. Split-dosing is preferred for achieving a high-quality preparation.
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Affiliation(s)
- Prateek Sharma
- University of Kansas Medical Center, Kansas City, Kansas, United States
| | | | - David A. Johnson
- Eastern Virginia Medical School, Norfolk, Virginia, United States
| | - Brooks D. Cash
- University of Texas Health Science Center, Houston, Texas, United States
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20
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Na SY, Moon W. [Optimal Laxatives for Oral Colonoscopy Bowel Preparation: from High-volume to Novel Low-volume Solutions]. THE KOREAN JOURNAL OF GASTROENTEROLOGY 2020; 75:65-73. [PMID: 32098459 DOI: 10.4166/kjg.2020.75.2.65] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/08/2020] [Revised: 02/17/2020] [Accepted: 02/17/2020] [Indexed: 12/14/2022]
Abstract
Optimal bowel preparation is essential for a more accurate, comfortable, and safe colonoscopy. The majority of postcolonoscopy colorectal cancers can be explained by procedural factors, mainly missed polyps or inadequate examination. Therefore the most important goal of optimal bowel preparation is to reduce the incidence of colorectal cancer. Although adequate preparation should be achieved in 85-90% or more of all colonoscopy as a quality indicator, unfortunately 20-30% shows inadequate preparation. Laxatives for oral colonoscopy bowel preparation can be classified into polyethylene glycol (PEG)-electrolyte lavage solution, osmotic laxatives, stimulant laxatives, and divided into high-volume solution (≥3 L) and low-volume solution (<3 L). The updated 2019 European Society of Gastrointestinal Endoscopy (ESGE) guideline is broadly similar to the 2014 American Society for Gastrointestinal Endoscopy (ASGE) recommendations and reaffirms the importance of split-dosing. However, new ESGE guideline, unlike the 2014 ASGE recommendation, suggests the use of high volume or low volume PEG-based regimens as well as that of non-PEG based agents that have been clinically validated for most outpatient scenarios. For effective, safe, and highly adherent bowel preparation, physicians who prescribe and implement colonoscopy should properly know the advantages and limitations, the dosing, and the timing of regimens. Recently many studies have attempted to find the most ideal regimens, and more convenient, effective, and safe regimens have been developed by reducing the dosing volume and improving the taste. The high tolerability and acceptability of the new low-volume regimens suggest us how we should use it to increase the participation of the national colorectal cancer screening program.
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Affiliation(s)
- Soo-Young Na
- Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea
| | - Won Moon
- Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea
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Yang HJ, Park DI, Park SK, Lee CK, Kim HJ, Oh SJ, Moon JR, Lee BJ, Koh JS, Kim HS, Park SY, Kim DH, Chun J, Kang EA, Kim J, Soh H, Eun CS, Kim YS, Jeen YT. Novel sulfate tablet PBK-1701TC versus oral sulfate solution for colon cleansing: A randomized phase 3 trial. J Gastroenterol Hepatol 2020; 35:29-36. [PMID: 31396995 DOI: 10.1111/jgh.14826] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/03/2019] [Revised: 07/13/2019] [Accepted: 08/06/2019] [Indexed: 12/17/2022]
Abstract
BACKGROUND AND AIM PBK-1701TC is a novel sulfate tablet-based that contains 320 mg of simethicone and delivers 90% of the salt and water delivered by oral sulfate solution (OSS) preparation. This study evaluated the efficacy, safety, and tolerability of PBK-1701TC compared with OSS in bowel preparation for colonoscopy. METHODS This randomized, multicenter, phase 3 non-inferiority trial included adults aged 19 years or older with a body mass index of 19-30 kg/m2 undergoing colonoscopy at five university hospitals in Korea. The primary efficacy endpoint was successful bowel-cleansing rate, defined as Harefield Cleansing Scale grade A or B as evaluated by blinded central readers. Secondary endpoints included the presence of residual air bubbles. Adverse events and laboratory evaluations were monitored to assess safety. Tolerability was assessed via participant interview. RESULTS Overall, 235 participants were randomized, and 224 were included in the per-protocol analysis (PBK, 112; OSS, 112). Successful bowel cleansing was achieved for 95.5% (107/112) in the PBK group, which was non-inferior to the OSS group (98.2%, 110/112) with a difference of -2.7% (one sided 97.5% confidence limit, -8.1%). The participants in the PBK group had fewer intraluminal bubbles (0.9% vs 81.3%, P < 0.001) and reported a lower incidence of nausea and vomiting, with better acceptance, taste, and willingness to repeat the regimen than those in the OSS group (all P < 0.05). CONCLUSION The novel sulfate tablet, PBK-1701TC, was non-inferior to OSS with respect to bowel-cleansing efficacy and exhibited better safety and tolerability in adults undergoing colonoscopy.
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Affiliation(s)
- Hyo-Joon Yang
- Division of Gastroenterology, Department of Internal Medicine and Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Dong Il Park
- Division of Gastroenterology, Department of Internal Medicine and Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Soo-Kyung Park
- Division of Gastroenterology, Department of Internal Medicine and Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Chang Kyun Lee
- Center for Crohn's and Colitis, Department of Gastroenterology and Hepatology, Kyung Hee University School of Medicine, Seoul, Korea
| | - Hyo Jong Kim
- Center for Crohn's and Colitis, Department of Gastroenterology and Hepatology, Kyung Hee University School of Medicine, Seoul, Korea
| | - Shin Ju Oh
- Center for Crohn's and Colitis, Department of Gastroenterology and Hepatology, Kyung Hee University School of Medicine, Seoul, Korea
| | - Jung Rock Moon
- Center for Crohn's and Colitis, Department of Gastroenterology and Hepatology, Kyung Hee University School of Medicine, Seoul, Korea
| | - Beom Jae Lee
- Division of Gastroenterology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea
| | - Jin Sung Koh
- Division of Gastroenterology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea
| | - Hyun Soo Kim
- Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
| | - Seon-Young Park
- Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
| | - Dong Hyun Kim
- Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
| | - Jaeyoung Chun
- Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Eun Ae Kang
- Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Jung Kim
- Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Hosim Soh
- Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Chang Soo Eun
- Department of Internal Medicine, Hanyang University Guri Hospital, Gyeonggi-Do, Korea
| | - You Sun Kim
- Department of Internal Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Yoon Tae Jeen
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
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Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. J Clin Gastroenterol 2019; 53:e431-e437. [PMID: 30308546 DOI: 10.1097/mcg.0000000000001137] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
BACKGROUND/AIMS This study aimed to compare the efficacy and tolerability of an oral sulfate solution (OSS) versus 2 L of polyethylene glycol/ascorbic acid (2L-PEG/Asc) for bowel cleansing before colonoscopy. METHODS A prospective, single-center, single-blinded, noninferiority, randomized, controlled trial was performed. The primary outcome was the rate of successful bowel cleansing, evaluated using the Boston Bowel Preparation Scale (BBPS). Secondary outcomes were examination time, polyp, and adenoma detection rate (PDR and ADR), tolerability, and safety. Ease of use, palatability, intention to reuse, and satisfaction were evaluated using a questionnaire. RESULTS A total of 187 participants were randomized to receive either OSS (n=93) or 2L-PEG/Asc (n=94). Successful bowel cleansing was achieved in 86.0% (80/93) of the OSS group, which was noninferior to the 2L-PEG/Asc group (88.3%, 83/94), with a difference of -2.3% by ITT analysis [95% confidence interval (CI) -12.0 to +7.4]. The withdrawal time of the OSS group was significantly shorter than that of the 2L-PEG/Asc group (11.8±5.2 vs. 14.3±8.5; P=0.016). Ease of use, palatability, intention to reuse, and satisfaction were similar between the 2 groups. Adverse events were also similar between the 2 groups. Mucosal erythema (4.3%) and aphthous lesions (2.1%) were found only in the 2L-PEG/Asc group. CONCLUSIONS OSS was as effective as 2L-PEG/Asc for successful bowel cleansing and had acceptable tolerability. OSS is a promising and safe low-volume preparation alternative for colonoscopy. (Clinical trial registration number: NCT02761213.).
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Yang HJ, Park DI, Park SK, Kim S, Lee T, Jung Y, Eun CS, Han DS. A Randomized Controlled Trial Comparing Colonoscopic Enema With Additional Oral Preparation as a Salvage for Inadequate Bowel Cleansing Before Colonoscopy. J Clin Gastroenterol 2019; 53:e308-e315. [PMID: 30001288 DOI: 10.1097/mcg.0000000000001087] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
GOALS The goal of this study was to evaluate the noninferiority of colonoscopic enema to additional oral preparation in salvage bowel cleansing for inadequate preparation for a morning colonoscopy. BACKGROUND Colonoscopic enema, administering additional cathartics into the right colon through the colonoscope accessory channel, is suggested to rescue poor bowel preparation for a colonoscopy but lacking comparative study. STUDY In this prospective, randomized, actively-controlled, parallel group, noninferiority trial, consecutive outpatients and health checkup recipients aged from 19 to 70 years with inappropriate bowel preparation during an elective colonoscopy were enrolled to receive either a colonoscopic enema of 1 L polyethylene glycol (PEG) (enema group) or additional oral intake of 2 L PEG (oral group). The primary endpoint was the proportion of adequate bowel preparation evaluated using the Boston Bowel Preparation Scale. RESULTS Overall, 131 participants were randomized. Adequate bowel preparation was achieved in 53% (35/66) of the enema group, which was significantly inferior to the oral group (81.5%; 53/67) with a difference of -28.5% (95% confidence interval, -44.1, -12.9; P=0.001). The largest difference in the proportion of adequate bowel preparation was observed in the right colon (57.8% in the enema group vs. 86.9% in the oral group; P<0.001), followed by the transverse colon (85.9% vs. 98.4%; P=0.017) and the left colon (90.6% vs. 96.7%; P=0.274). CONCLUSIONS The colonoscopic enema of 1 L PEG was inferior to the additional oral ingestion of 2 L PEG regarding efficacy as a salvage bowel preparation in adults with inadequate bowel cleansing for colonoscopy.
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Affiliation(s)
- Hyo-Joon Yang
- Department of Internal Medicine and Gastrointestinal Cancer Center, Division of Gastroenterology
| | - Dong Il Park
- Department of Internal Medicine and Gastrointestinal Cancer Center, Division of Gastroenterology
| | - Soo-Kyung Park
- Department of Internal Medicine and Gastrointestinal Cancer Center, Division of Gastroenterology
| | - Sunyong Kim
- Total Healthcare Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul
| | - Taeheon Lee
- Total Healthcare Center, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul
| | - Yunho Jung
- Department of Internal Medicine, Division of Gastroenterology, Soonchunhyang University College of Medicine, Cheonan
| | - Chang Soo Eun
- Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Republic of Korea
| | - Dong Soo Han
- Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Republic of Korea
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The Efficacy of Split-Dose Bowel Preparations for Polyp Detection: A Systematic Review and Meta-Analysis. Am J Gastroenterol 2019; 114:884-892. [PMID: 30865011 DOI: 10.14309/ajg.0000000000000155] [Citation(s) in RCA: 25] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
INTRODUCTION Split-dose bowel preparation leads to superior colon cleansing for colonoscopy. However, the magnitude of benefit in detecting colonic polyps is uncertain. We performed a systematic review to synthesize the data on whether using a split-dose bowel preparation regimen improves the detection of polyps when compared with other dosing methods or regimen products. METHODS We searched MEDLINE, EMBASE, and CENTRAL databases (from the inception to June 2017) for randomized controlled trials that assessed the following: split-dose vs day-before, split-dose vs same-day (as colonoscopy), or different types of split-dose regimens for patients undergoing colonoscopy. We excluded studies limited to inpatients, children, or individuals with inflammatory bowel disease. We compared the number of patients undergoing colonoscopy with recorded detection of polyps, adenomas, advanced adenomas, sessile serrated polyps (SSPs), right colonic adenomas, right colonic polyps, or right colonic SSPs. RESULTS Twenty-eight trials fulfilled the inclusion criteria (8,842 participants). Of the seven trials comparing split-dose vs day-before bowel preparation regimens, there was an increased detection rate of adenomas (risk ratio (RR) 1.26, 95% confidence intervals (CIs): 1.10-1.44; 4 trials; 1,258 participants), advanced adenomas (RR 1.53, 95% CI: 1.22-1.92; 3 trials; 1,155 participants), and SSPs (RR 2.48, 95% CI: 1.21-5.09; 2 trials; 1,045 participants). Pooled estimates from 8 trials (1,587 participants) evaluating split-dose vs same-day bowel preparations yielded no evidence of statistical difference. For various split-dose vs split-dose trials, 14 fulfilled the criteria (5,496 participants) and no superior split-regimen was identified. CONCLUSIONS Compared with day-before bowel preparation regimens, split-dose bowel preparations regimens increase the detection of adenomas, advanced adenomas, and have the greatest benefit in SSP detection.
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Comparison of asymmetric (low morning-dose) and standard split-dose regimen of PEG plus bisacodyl for bowel preparation: A randomized controlled trial. Dig Liver Dis 2019; 51:837-842. [PMID: 30658942 DOI: 10.1016/j.dld.2018.12.012] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/11/2018] [Revised: 11/25/2018] [Accepted: 12/16/2018] [Indexed: 12/11/2022]
Abstract
BACKGROUND Reducing the morning dose of PEG solution may be a reliable strategy to improve the patient compliance of split-dose regimens without affecting efficacy of bowel cleansing. AIMS to compare the efficacy for bowel cleansing of an asymmetric split-dose regimen (25% of the dose on the day of colonoscopy and 75% on the day before) with the standard split-dose regimen. METHODS Outpatients were enrolled in a randomized, single-blind, non-inferiority clinical trial. All subjects received a split-dose preparation with a 2L PEG-citrate-simethicone plus Bisacodyl. Patients were randomly assigned to: group A, asymmetric split-dose regimen; group B, symmetric split-dose regimen. Primary endpoint was the proportion of adequate bowel cleansing. RESULTS Split-dose was taken by 81 and 80 patients in group A and B. Adequate bowel cleansing was achieved in 92.6% and 92.5% patients in group A and B (p = 1.000). No differences were observed regarding Boston Bowel Preparation Scale total score, adenoma detection rate and scores of each colon segment. CONCLUSIONS The reduction of morning dose of PEG in a split-dose regimen is not inferior to the standard split-dose regimen in achieving an adequate bowel cleansing. However, further studies are needed to evaluate whether asymmetric preparation is associated to a higher tolerability compared to symmetric split-dose regimen. (NCT03146052).
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Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided colon cleansing: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc 2018; 87:677-687.e3. [PMID: 28803744 DOI: 10.1016/j.gie.2017.07.047] [Citation(s) in RCA: 57] [Impact Index Per Article: 8.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/26/2017] [Accepted: 07/30/2017] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS NER1006 is the first 32 fluid ounce (1 L) polyethylene glycol-based bowel preparation. This randomized, multicenter, colonoscopist/central reader-blinded phase 3 non-inferiority trial assessed the efficacy, safety, and tolerability of NER1006 versus trisulfate for bowel cleansing. METHODS Patients undergoing colonoscopy were randomized (1:1) to receive NER1006 or trisulfate, using evening/morning split-dosing administration. Blinded central readers used the validated Harefield Cleansing Scale to evaluate 2 alternative primary endpoints: overall bowel-cleansing success and high-quality cleansing of the ascending colon/cecum. Secondary endpoints included lesion detection, Boston Bowel Preparation Scale (BBPS) assessment, and adherence. The non-inferiority margin was 10% and the significance threshold was P < .025. RESULTS Of 621 patients randomized (NER1006, n=310; trisulfate, n=311), 556 were evaluated for efficacy (NER1006, n=276; trisulfate, n=280). NER1006 achieved non-inferiority versus trisulfate for both primary endpoints of overall bowel-cleansing success (85.1% vs 85.0%; difference, 0.14%; one-sided 97.5% lower confidence limit [LCL], -8.15%; P = .528) and high-quality cleansing of the ascending colon/cecum (35.9% versus 29.3%; difference, 6.58%; LCL, -1.69%; P = .059). BBPS assessments supported overall bowel-cleansing success rates. Lesion detection rates were similar between the groups. The percentage of patients with treatment-related adverse events was 14.9% with NER1006 and 9.4% with trisulfate. Both bowel preparations showed similar overall tolerability and safety profiles. Adherence was very high in both arms. CONCLUSIONS With evening/morning split dosing, NER1006 was as effective as trisulfate for overall bowel and right-sided colon cleansing. Adverse event rates were slightly higher with NER1006 than trisulfate, but did not compromise tolerability, adherence, or efficacy. (Clinical trial registration number: NCT02254486.).
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Predicting Suboptimal Bowel Preparation: Taking It Up a PEG. Dig Dis Sci 2017; 62:289-291. [PMID: 27878647 DOI: 10.1007/s10620-016-4385-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2016] [Accepted: 11/15/2016] [Indexed: 12/09/2022]
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