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Zhou Q, Kang JK, Zhi YF, Ma MJ, Ren XD, Gan ZN, Niu J. Synchronous triple primary colorectal cancer: a rare case report from a rural tibetan population. Discov Oncol 2025; 16:839. [PMID: 40397067 PMCID: PMC12095748 DOI: 10.1007/s12672-025-02647-4] [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: 01/14/2025] [Accepted: 05/09/2025] [Indexed: 05/22/2025] Open
Abstract
Synchronous multiple colorectal cancers (SMCRC) are rare and defined as distinct malignant tumors occurring simultaneously in the colon and rectum without evidence of metastasis from one tumor to another. This case report presents a 69 year-old Tibetan male admitted with acute abdominal pain, abdominal distension, nausea, and vomiting. Imaging studies and colonoscopy revealed synchronous cancers in the rectum, sigmoid colon, and transverse colon, all pathologically confirmed as moderately differentiated adenocarcinomas. The patient underwent a multisegment colectomy with complete resection of all tumors. Postoperative recovery was uneventful, and no recurrence was reported during follow-up. This case underscores the importance of thorough diagnostic and surgical strategies for SMCRC, particularly in emergency presentations where limited diagnostic modalities may pose challenges.
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Affiliation(s)
- Qing Zhou
- Department of Gastrointestinal Surgery, Qinghai Red Cross Hospital, Xi'ning, 810000, China
| | - Jin-Ke Kang
- Department of Gastrointestinal Surgery, Qinghai Red Cross Hospital, Xi'ning, 810000, China
| | - Yong-Fa Zhi
- Department of Gastrointestinal Surgery, Qinghai Red Cross Hospital, Xi'ning, 810000, China
| | - Ming-Jie Ma
- Department of Gastrointestinal Surgery, Qinghai Red Cross Hospital, Xi'ning, 810000, China
| | - Xiao-de Ren
- Department of Gastrointestinal Surgery, Qinghai Red Cross Hospital, Xi'ning, 810000, China
| | - Zheng-Ning Gan
- Department of Imaging, Qinghai Red Cross Hospital, Xi'ning, 810000, China
| | - Jie Niu
- Ophthalmology Department III, Xining First People's Hospital, No. 3, Huzhu Lane, Chengzhong District, Xi'ning, 810000, Qinghai Province, China.
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Gao L, Zhang T, Chen X, Dong S, Chen D, Liu N, Tang B. Bile acid in drainage fluid for early diagnosis of anastomotic leakage and safe discharge after minimally invasive rectal cancer resection: A prospective cohort study. Surgery 2025; 178:108949. [PMID: 39657328 DOI: 10.1016/j.surg.2024.10.032] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/06/2024] [Revised: 10/15/2024] [Accepted: 10/30/2024] [Indexed: 12/12/2024]
Abstract
BACKGROUND This study was designed to evaluate the diagnostic value of bile acid levels in drainage fluid for early prediction and exclusion of anastomotic leakage, and assess the performance in allowing a safe discharge. METHODS This prospective single-center study was conducted in patients diagnosed with rectal cancer who had received minimally invasive anterior resection consecutively from December 2021 to March 2024. Bile acid in drainage fluid, C-reactive protein, and procalcitonin in serum were measured on the third and fifth day after surgery. Four criteria were considered in discharging patients: a C-reactive protein level below 100 mg/L, flatus with or without defecation, a restore of liquid diet, a bile acid level less than 2 μmol/L. RESULTS A total of 419 patients were included and divided into an anastomotic leakage group (n = 37; 8.8%) and a nonanastomotic leakage group (n = 382; 91.2%). Of those patients, 384 accorded with the discharge criteria and 380 of them (99%) discharged safely. The rate of anastomotic leakage after discharge and readmission was 0.5% and 0.3%. Bile acid levels in drainage fluid in the anastomotic leakage group were significantly greater than that in the nonanastomotic leakage group on both postoperative days 3 and 5 (postoperative day 3: 3.00 [2.00-5.17] μmol/L vs 0.80 [0.40-1.30] μmol/L, P < .001; and postoperative day 5: 5.17 [3.00-9.20] μmol/L vs 2.00 [1.40-3.50] μmol/L, P < .001). The negative predictive value in ruling out an anastomotic leakage were 0.96 on postoperative day 3 and 0.97 on postoperative day 5 for bile acid alone. CONCLUSION Drainage bile acid has a high negative predictive value in the early diagnosis of anastomotic leakage and showed potential to allow for safe discharge.
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Affiliation(s)
- Linfeng Gao
- Department of General Surgery, Southwest Hospital, Army Medical University, Chongqing, China
| | - Tao Zhang
- Department of General Surgery, Southwest Hospital, Army Medical University, Chongqing, China
| | - Xicheng Chen
- Department of Health Statistics, College of Preventive Medicine, Army Medical University, Chongqing, China
| | - Sen Dong
- Department of General Surgery, Southwest Hospital, Army Medical University, Chongqing, China
| | - Donglin Chen
- Department of General Surgery, Southwest Hospital, Army Medical University, Chongqing, China
| | - Nanhui Liu
- Department of General Surgery, Southwest Hospital, Army Medical University, Chongqing, China
| | - Bo Tang
- Department of General Surgery, Southwest Hospital, Army Medical University, Chongqing, China.
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Kasalović M, Odalović B, Mihajlović L, Jakovljević S, Elek Z, Igrutinović G, Anđelković M, Pajčin M. Prospective evaluation of serum and peritoneal fluid markers as indicators of postoperative complications in patients with enteric anastomosis. Ann Saudi Med 2024; 44:422-434. [PMID: 39651922 PMCID: PMC11627050 DOI: 10.5144/0256-4947.2024.422] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/24/2024] [Accepted: 10/27/2024] [Indexed: 12/12/2024] Open
Abstract
BACKGROUND Postoperative complications of colorectal cancer surgery contribute to increased morbidity and mortality in patients. OBJECTIVES Investigate the role of biochemical markers in serum and peritoneal fluid in the development of postoperative complications in patients with enteral anastomosis. DESIGN Prospective. SETTING University hospitals. PATIENTS AND METHODS The studied population consisted of patients who underwent surgical treatment with created anastomosis or Hartmann's resection from April 2022 to April 2024, conducted at the Clinical-Hospital Center Kosovska Mitrovica and the University Clinical Center Kragujevac. Spearman's correlation coefficient (rs) was used to test associations between categorical variables. MAIN OUTCOME MEASURES Lactate, albumin, lactate dehydrogenase, and IgA antibodies were monitored as predictors of anastomotic dehiscence and general postoperative complications. SAMPLE SIZE 52. RESULTS The concentration of lactate in the drain fluid on the third postoperative day was statistically significantly higher in patients who did not develop anastomotic dehiscence (P=.006). The concentration of IgA antibodies in the drain fluid on the third and fifth days post-surgery showed a moderate negative correlation with lactate concentration (rs=-.670, P=.012; rs=-.577, P=.039), repectively. There was a significantly higher concentration of albumin in the drain fluid on the third day post-surgery in patients who developed dehiscence (P=.040), and on the seventh day post-surgery in those who did not develop dehiscence (P=.001). The concentration of LDH on the third day in the drain fluid after surgery was statistically significantly higher in patients who did not develop dehiscence (P=.020). There was a statistically significant difference in lactate concentration in the drain fluid on the third (P<.001) and fifth days (P=.041) post-surgery, as well as in albumin concentration on the third day post-surgery (P=.024) with respect to the development of general postoperative complications. CONCLUSION This study revealed significant differences in the concentrations of lactate, albumin, and LDH in the drain fluid on the third and fifth days post-surgery with respect to the development of complications. These results suggest that monitoring these markers may help in the early identification of patients at risk of complications such as dehiscence. LIMITATIONS Limited literature on specific aspects of this study, including the absence of a control group, small sample size, and two-center study.
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Affiliation(s)
- Mladen Kasalović
- From the Surgical Clinic, Clinical Hospital Center Kosovska Mitrovica, Kosovska Mitrovica, Serbia
| | - Božidar Odalović
- From the Department of Surgery, Faculty of Medicine, University of Priština, Kosovska Mitrovica, Serbia
| | - Lazar Mihajlović
- From the Surgical Clinic, University Clinical Center Kragujevac, Kragujevac, Serbia
| | - Stefan Jakovljević
- From the Surgical Clinic, University Clinical Center Kragujevac, Kragujevac, Serbia
| | - Zlatan Elek
- From the Department of Surgery, Faculty of Medicine, University of Priština, Kosovska Mitrovica, Serbia
| | - Gojko Igrutinović
- From the Department of Surgery, Faculty of Medicine, University of Priština, Kosovska Mitrovica, Serbia
| | - Milena Anđelković
- From the Laboratory Diagnostics Service, Clinical Hospital Center, Kosovska Mitrovica, Serbia
| | - Mirjana Pajčin
- From the Faculty of Medicine, University of Pristina, Medical Statistics and Informatics, Kosovska Mitrovica, Serbia
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Huang Y, Li TY, Weng JF, Liu H, Xu YJ, Zhang S, Gu WL. Peritoneal fluid indocyanine green test for diagnosis of gut leakage in anastomotic leakage rats and colorectal surgery patients. World J Gastrointest Surg 2024; 16:1825-1834. [PMID: 38983318 PMCID: PMC11230036 DOI: 10.4240/wjgs.v16.i6.1825] [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: 01/13/2024] [Revised: 04/22/2024] [Accepted: 05/06/2024] [Indexed: 06/27/2024] Open
Abstract
BACKGROUND Application of indocyanine green (ICG) fluorescence has led to new developments in gastrointestinal surgery. However, little is known about the use of ICG for the diagnosis of postoperative gut leakage (GL). In addition, there is a lack of rapid and intuitive methods to definitively diagnose postoperative GL. AIM To investigate the effect of ICG in the diagnosis of anastomotic leakage in a surgical rat GL model and evaluate its diagnostic value in colorectal surgery patients. METHODS Sixteen rats were divided into two groups: GL group (n = 8) and sham group (n = 8). Approximately 0.5 mL of ICG (2.5 mg/mL) was intravenously injected postoperatively. The peritoneal fluid was collected for the fluorescence test at 24 and 48 h. Six patients with rectal cancer who had undergone laparoscopic rectal cancer resection plus enterostomies were injected with 10 mL of ICG (2.5 mg/mL) on postoperative day 1. Their ostomy fluids were collected 24 h after ICG injection to identify the possibility of the ICG excreting from the peripheral veins to the enterostomy stoma. Participants who had undergone colectomy or rectal cancer resection were enrolled in the diagnostic test. The peritoneal fluids from drainage were collected 24 h after ICG injection. The ICG fluorescence test was conducted using OptoMedic endoscopy along with a near-infrared fluorescent imaging system. RESULTS The peritoneal fluids from the GL group showed ICG-dependent green fluorescence in contrast to the sham group. Six samples of ostomy fluids showed green fluorescence, indicating the possibility of ICG excreting from the peripheral veins to the enterostomy stoma in patients. The peritoneal fluid ICG test exhibited a sensitivity of 100% and a specificity of 83.3% for the diagnosis of GL. The positive predictive value was 71.4%, while the negative predictive value was 100%. The likelihood ratios were 6.0 for a positive test result and 0 for a negative result. CONCLUSION The postoperative ICG test in a drainage tube is a valuable and simple technique for the diagnosis of GL. Hence, it should be employed in clinical settings in patients with suspected GL.
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Affiliation(s)
- Yu Huang
- Department of Surgery, Guangzhou First People's Hospital, Guangzhou 510180, Guangdong Province, China
| | - Tian-Yang Li
- Department of Surgery, Guangzhou First People's Hospital, Guangzhou 510180, Guangdong Province, China
| | - Jie-Feng Weng
- Department of Surgery, Guangzhou First People's Hospital, Guangzhou 510180, Guangdong Province, China
| | - Hui Liu
- Department of Surgery, Guangzhou First People's Hospital, Guangzhou 510180, Guangdong Province, China
| | - Yu-Jie Xu
- Department of Surgery, Guangzhou First People's Hospital, Guangzhou 510180, Guangdong Province, China
| | - Shuai Zhang
- Department of Surgery, Guangzhou First People's Hospital, Guangzhou 510180, Guangdong Province, China
| | - Wei-Li Gu
- Department of Surgery, Guangzhou First People's Hospital, Guangzhou 510180, Guangdong Province, China
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Jørgensen AB, Jonsson I, Friis-Hansen L, Brandstrup B. Collagenase-producing bacteria are common in anastomotic leakage after colorectal surgery: a systematic review. Int J Colorectal Dis 2023; 38:275. [PMID: 38038731 PMCID: PMC10692267 DOI: 10.1007/s00384-023-04562-y] [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] [Accepted: 11/08/2023] [Indexed: 12/02/2023]
Abstract
PURPOSE Some gut bacteria can produce enzymes (collagenases) that can break down collagen in the intestinal wall. This could be a part of the pathophysiology of anastomotic leakage (AL). This systematic review aimed to investigate if such bacteria were present more frequently in AL patients versus non-AL patients following colorectal surgery. METHODS This systematic review was reported according to the PRISMA and AMSTAR guidelines. Before the literature search, a study protocol was registered at PROSPERO (CRD42022363454). We searched PubMed, EMBASE, Google Scholar, and Cochrane CENTRAL on April 9th, 2023, for randomized and observational human studies of AL following colorectal surgery with information on gastrointestinal bacteria. The primary outcome was bacteria with the potential to produce collagenase. The risk of bias was assessed with the Newcastle-Ottawa Scale, as all studies were observational. RESULTS We included 15 studies, with a total of 52,945 patients, of which 1,747 had AL, and bacteriological information from feces, mucosa, the resected specimen, or drain fluid was presented. In 10 of the 15 studies, one or more collagenase-producing bacteria were identified in the patients with AL. Neither the bacteria nor the collagenase production were quantified in any of the studies. The studies varied greatly in terms of sample material, analytical method, and time of collection. Studies using DNA sequencing methods did not report findings of collagenase-producing bacteria. CONCLUSION Collagenase-producing bacteria are more common in patients with AL following colorectal surgery than in patients without AL, but the significance is unclear. From the current studies, it is not possible to determine the pathogenicity of the individual gut bacteria.
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Affiliation(s)
- Anders Bech Jørgensen
- Department of Surgery, Holbæk Hospital, Part of Copenhagen University Hospitals, Region Zealand, Denmark.
- Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
| | - Isabella Jonsson
- Department of Surgery, Holbæk Hospital, Part of Copenhagen University Hospitals, Region Zealand, Denmark
| | - Lennart Friis-Hansen
- Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
- Department of Clinical Biochemistry, Bispebjerg and Frederiksberg University Hospital, Capital Region, Frederiksberg, Denmark
- Department of Microbiology, Rigshospitalet, Capital Region, Denmark
| | - Birgitte Brandstrup
- Department of Surgery, Holbæk Hospital, Part of Copenhagen University Hospitals, Region Zealand, Denmark
- Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Villegas-Coronado L, Villegas-Coronado K, Villegas Coronado D. Peritoneal and Systemic Interleukin-10 as Early Biomarkers for Colorectal Anastomotic Leakage Following Surgery in Colorectal Cancer Patients: A Systematic Review and Meta-Analysis. POLISH JOURNAL OF SURGERY 2023; 96:135-142. [PMID: 38348991 DOI: 10.5604/01.3001.0053.9836] [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] [Indexed: 02/15/2024]
Abstract
<b><br>Introduction:</b> Despite advancements in diagnostic methods, the early detection of colorectal anastomotic leakage (CAL) continues to pose challenges. The identification of reliable markers is crucial to reduce patient morbidity and mortality. Cytokines present in drain fluid and systemic cytokine levels have shown promise as predictive markers for CAL; however, additional high-quality evidence is warranted to enhance the reliability and validity of the findings in this field.</br> <b><br>Aim:</b> This systematic review and meta-analysis aimed to assess the significance of peritoneal and serum/plasma interleukin-10 (IL-10) levels in the early detection of CAL in patients undergoing colorectal surgery for colorectal cancer.</br> <b><br>Methods:</b> A comprehensive literature search was conducted in PubMed, Scopus, and Web of Science databases, covering studies published until July 2023. The search aimed to identify relevant studies investigating the levels of plasma/serum and peritoneal IL-10 (or both) in colorectal cancer patients undergoing colorectal surgery, specifically focusing on the presence of CAL. Data on the mean and standard deviation of IL-10 levels in both CAL and non-CAL patients were extracted from the selected studies. Mean differences in IL-10 levels were analyzed for each postoperative day (POD) using the OpenMeta [analyst] software.</br> <b><br>Results:</b> 11 articles were selected for inclusion in this systematic review. Among them, nine articles reported data on peritoneal IL-10 levels, while four articles focused on circulating IL-10 levels. The statistical analysis included four eligible articles that assessed peritoneal IL-10 levels, and the results indicated no significant increase in CAL patients compared to non-CAL patients on any postoperative day (POD). Meta-analysis for circulating IL-10 levels was not feasible.</br> <b><br>Conclusions:</b> Up to now, peritoneal and systemic IL-10 levels cannot be considered as early markers for CAL after colorectal surgery in colorectal cancer patients. More high-quality studies are needed to establish the potential of IL-10 as a reliable marker for detecting anastomotic leakage after colorectal surgery.</br>.
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Affiliation(s)
- Lucía Villegas-Coronado
- Programa de Especialización en Cirugía General, Unidad de Cirugía, Hospital General de Zona No. 5, Instituto Mexicano del Seguro Social, Nogales, México
| | - Karla Villegas-Coronado
- Programa de Especialización en Geriatría, Hospital General de Zona No. 89, Instituto Mexicano del Seguro Social, Guadalajara, México
| | - Diana Villegas Coronado
- Departamento de Investigaciones en Polímeros y Materiales, Universidad de Sonora, Hermosillo, México
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Carbone F, Petz W, Borin S, Bertani E, de Pascale S, Zampino MG, Fumagalli Romario U. Tumour-specific mesorectal excision for rectal cancer: Systematic review and meta-analysis of oncological and functional outcomes. EUROPEAN JOURNAL OF SURGICAL ONCOLOGY 2023; 49:107069. [PMID: 37708660 DOI: 10.1016/j.ejso.2023.107069] [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: 05/30/2023] [Revised: 08/11/2023] [Accepted: 09/08/2023] [Indexed: 09/16/2023]
Abstract
BACKGROUND Tumour-specific mesorectal excision (TSME) practice for rectal cancer only relies on small retrospective studies. This study aimed to perform a systematic review and meta-analysis to assess the oncological and functional outcomes of TSME practice. METHODS A systematic review protocol was drawn to include all the studies that compared partial versus total mesorectal excision (PME vs TME) practised for rectal adenocarcinoma up to 16 cm from the anal verge. A systematic literature search was conducted on EMBASE-Medline, Pubmed and Cochrane Library. Reports were screened for the study's outcomes: oncological radicality, postoperative anastomotic leak risk and functional outcomes. Included studies were appraised for risk-of-bias and meta-analysed. Evidence was rated with the GRADE approach. RESULTS Twenty-seven studies were included, consisting of 12325 patients (PME n = 4460, 36.2%; TME n = 7865, 63.8%). PME was performed for tumours higher than 10 cm from the anal verge in 54.5% of patients. There was no difference between PME and TME in circumferential resection margin positivity (OR 1.31, 95%CI 0.43-3.95, p = 0.64; I2 = 38%), and local recurrence risk (HR 1.05, 95%CI 0.52-2.10, p = 0.90; I2 = 40%). The postoperative leak risk (OR 0.42, 95%CI 0.27-0.67, p < 0.001; I2 = 60%) and the major low anterior resection syndrome risk (OR 0.34, 95%CI 0.28-0.40, p < 0.001; I2 = 0%) were lower after PME surgery. No difference was found in urinary incontinence (OR 0.68, 95%CI 0.13-3.67, p = 0.66) and urinary retention after early catheter removal (OR 2.00, 95%CI 0.24-16.51, p = 0.52). CONCLUSIONS Evidence from this meta-analysis shows that TSME for rectal cancer has good oncological results and leads to the best-fitted functional results possible for the patient's condition.
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Affiliation(s)
- Fabio Carbone
- Digestive Surgery, European Institute of Oncology IRCCS, Milan, Italy.
| | - Wanda Petz
- Digestive Surgery, European Institute of Oncology IRCCS, Milan, Italy.
| | - Simona Borin
- Digestive Surgery, European Institute of Oncology IRCCS, Milan, Italy.
| | - Emilio Bertani
- Digestive Surgery, European Institute of Oncology IRCCS, Milan, Italy.
| | | | - Maria Giulia Zampino
- Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology IRCCS, Milan, Italy.
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Ozata IH, Bozkurt E, Sucu S, Karahan SN, Camci F, Cetin F, Ozoran E, Agcaoglu O, Balik E, Bugra D. A novel scoring system for the early detection of anastomotic leakage: bedside leak score-a pilot study. Front Surg 2023; 10:1204785. [PMID: 37601530 PMCID: PMC10434221 DOI: 10.3389/fsurg.2023.1204785] [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: 04/12/2023] [Accepted: 07/12/2023] [Indexed: 08/22/2023] Open
Abstract
Background Anastomotic leakage is a major complication in colorectal surgery, resulting in significant morbidity and mortality rates. Despite substantial progress in surgical technique, anastomotic leakage rates remain stable. An early diagnosis of anastomotic leaks was proven to reduce adverse outcomes and improve survival. Objective This study aims to find a novel scoring system for detecting anastomotic leaks using inflammatory and nutritional indicators after colorectal surgery. Our purpose was to analyze the diagnostic accuracy of leak scores ( ( CRP POD 3 ) ( CRP POD 1 ) ∗ preoperative albumin level ) in predicting postoperative complications. Design The study included colorectal cancer patients who underwent curative surgery at Koc University Hospital between 2014 and 2018. Patients were categorized into two groups depending on the presence of anastomotic leaks and compared in terms of preoperative albumin levels, CRP levels in postoperative days 1 and 3, anastomotic leakage rates, length of hospital stay, and CRP quotient, which was calculated by dividing POD 3 CRP level to POD 1 CRP level. The bedside leak score is calculated by dividing the CRP quotient by the preoperative albumin level. The predictive value of bedside leak score, CRP quotient, and preoperative albumin levels in estimating anastomotic leakage was analyzed, and a cutoff value for the leak score was calculated. Results A total of 184 patients were included in the study. The leak score, CRP POD 3-1 ratio, and preoperative albumin levels were found to successfully detect anastomotic leakage. The area under the curve for the leak score was calculated as 0.78. The optimal cutoff value was found to be 50.3 for the bedside leak score, which shows 90.9% sensitivity and 59.3% specificity. Conclusion The leak score may represent a valuable diagnostic tool for detecting patients at risk for anastomotic leakage after colorectal surgery and planning a better strategy to reduce morbidity and mortality rates and associated costs. However, further multicenter studies with large cohorts are necessary to confirm these results.
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Affiliation(s)
- Ibrahim H. Ozata
- Department of General Surgery, Koç University School of Medicine, Istanbul, Turkey
| | - Emre Bozkurt
- Department of General Surgery, Koç University School of Medicine, Istanbul, Turkey
| | - Serkan Sucu
- Department of General Surgery, Koç University School of Medicine, Istanbul, Turkey
| | - Salih N. Karahan
- Department of General Surgery, Koç University School of Medicine, Istanbul, Turkey
| | - Furkan Camci
- Koc University School of Medicine, Istanbul, Turkey
| | - Feyza Cetin
- Department of General Surgery, Koç University School of Medicine, Istanbul, Turkey
| | - Emre Ozoran
- Department of General Surgery, Koç University School of Medicine, Istanbul, Turkey
| | - Orhan Agcaoglu
- Department of General Surgery, Koç University School of Medicine, Istanbul, Turkey
| | - Emre Balik
- Department of General Surgery, Koç University School of Medicine, Istanbul, Turkey
| | - Dursun Bugra
- Department of General Surgery, Koç University School of Medicine, Istanbul, Turkey
- Department of General Surgery, VKV American Hospital, Istanbul, Turkey
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Axman E, Holmberg H, Rutegård M, de la Croix H. Association between previous inguinal hernia surgery and the risk of anastomotic leakage after colorectal surgery: nationwide registry-based study. BJS Open 2023; 7:zrad076. [PMID: 37650245 PMCID: PMC10469297 DOI: 10.1093/bjsopen/zrad076] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2023] [Revised: 06/27/2023] [Accepted: 06/29/2023] [Indexed: 09/01/2023] Open
Affiliation(s)
- Erik Axman
- The Queen Silvia Children´s Hospital, Department of Pediatric Surgery, Gothenburg, Sweden
- Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Henrik Holmberg
- Department of Epidemiology and Global Health, Umeå University, Umeå, Sweden
| | - Martin Rutegård
- Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden
- Wallenberg Centre for Molecular Medicine, Umeå University, Umeå, Sweden
| | - Hanna de la Croix
- Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Sahlgrenska University Hospital/Östra Hospital, Department of Surgery, Gothenburg, Sweden
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Witte MB, Saupe J, Reiner J, Bannert K, Schafmayer C, Lamprecht G, Berlin P. Ileocolonic Healing after Small Ileocecal Resection in Mice: NOD2 Deficiency Impairs Anastomotic Healing by Local Mechanisms. J Clin Med 2023; 12:3601. [PMID: 37240707 PMCID: PMC10219437 DOI: 10.3390/jcm12103601] [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: 04/03/2023] [Revised: 05/12/2023] [Accepted: 05/18/2023] [Indexed: 05/28/2023] Open
Abstract
Ileocecal resection (ICR) is frequently performed in Crohn's disease (CD). NOD2 mutations are risk factors for CD. Nod2 knockout (ko) mice show impaired anastomotic healing after extended ICR. We further investigated the role of NOD2 after limited ICR. C57B16/J (wt) and Nod2 ko littermates underwent limited ICR including 1-2 cm terminal ileum and were randomly assigned to vehicle or MDP treatment. Bursting pressure was measured on POD 5, and the anastomosis was analyzed for matrix turn-over and granulation tissue. Wound fibroblasts from subcutaneously implanted sponges were used for comparison. The M1/M2 macrophage plasma cytokines were analyzed. Mortality was not different between groups. Bursting pressure was significantly decreased in ko mice. This was associated with less granulation tissue but was not affected by MDP. However, anastomotic leak (AL) rate tended to be lower in MDP-treated ko mice (29% vs. 11%, p = 0.07). mRNA expression of collagen-1α (col1 α), collagen-3α (col3 α), matrix metalloproteinase (mmp)2 and mmp9 was increased in ko mice, indicating increased matrix turn-over, specifically in the anastomosis. Systemic TNF-α expression was significantly lower in ko mice. Ileocolonic healing is impaired in Nod2 ko mice after limited ICR by local mechanisms maybe including local dysbiosis.
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Affiliation(s)
- Maria B. Witte
- Department of General, Visceral, Thoracic, Vascular and Transplant Surgery, Rostock University Medical Center, Schillingallee 35, 18057 Rostock, Germany
| | - Johannes Saupe
- Division of Gastroenterology and Endocrinology, Department of Medicine II, Rostock University Medical Center, Ernst-Heydemann-Strasse 6, 18057 Rostock, Germany
| | - Johannes Reiner
- Division of Gastroenterology and Endocrinology, Department of Medicine II, Rostock University Medical Center, Ernst-Heydemann-Strasse 6, 18057 Rostock, Germany
| | - Karen Bannert
- Division of Gastroenterology and Endocrinology, Department of Medicine II, Rostock University Medical Center, Ernst-Heydemann-Strasse 6, 18057 Rostock, Germany
| | - Clemens Schafmayer
- Department of General, Visceral, Thoracic, Vascular and Transplant Surgery, Rostock University Medical Center, Schillingallee 35, 18057 Rostock, Germany
| | - Georg Lamprecht
- Division of Gastroenterology and Endocrinology, Department of Medicine II, Rostock University Medical Center, Ernst-Heydemann-Strasse 6, 18057 Rostock, Germany
| | - Peggy Berlin
- Division of Gastroenterology and Endocrinology, Department of Medicine II, Rostock University Medical Center, Ernst-Heydemann-Strasse 6, 18057 Rostock, Germany
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Qi XY, Tan F, Liu MX, Xu K, Gao P, Yao ZD, Zhang N, Yang H, Zhang CH, Xing JD, Cui M, Su XQ. Serum and peritoneal biomarkers for the early prediction of symptomatic anastomotic leakage in patients following laparoscopic low anterior resection: A single-center prospective cohort study. Cancer Rep (Hoboken) 2023; 6:e1781. [PMID: 36718787 PMCID: PMC10075299 DOI: 10.1002/cnr2.1781] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/09/2022] [Revised: 12/14/2022] [Accepted: 01/02/2023] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Anastomotic leakage (AL) is one of the common complications after rectal cancer surgery. This study aimed to evaluate the combination of biomarkers for the early prediction of symptomatic AL after surgery. METHODS A prospective cohort study evaluated the serum and peritoneal biomarkers of patients who underwent laparoscopic low anterior resection (Lap LAR) from November 1, 2021, to May 1, 2022. Multivariate-penalized logistic regression was performed to explore the independent biomarker with a P-value <.1, and receiver operating characteristic (ROC) curve was used to analyze the area under the curve (AUC), sensitivity, and specificity of the independent biomarkers. A predictive model for symptomatic AL was built based on the independent biomarkers and was visualized with a nomogram. The calibration curve with the concordance index (c-index) was further applied to evaluate the efficacy of the predictive model. RESULTS A total of 157 patients were included in this study, and 7 (4.5%) were diagnosed with symptomatic AL. C-reactive protein/album ratio (CAR) on postoperative day 1 and systemic immune-inflammation index (SII) and peritoneal interleukin-6 (IL-6) on postoperative day 3 were proven to be independent predictors for the early prediction of symptomatic AL. The optimal cutoff values of CAR, SII, and peritoneal IL-6 were 1.04, 916.99, and 26430.09 pg/ml, respectively. Finally, the nomogram, including these predictors, was established, and the c-index of this nomogram was 0.812, indicating that the nomogram could be used for potential clinical reference. CONCLUSION The combination of CAR, SII, and peritoneal IL-6 might contribute to the early prediction of symptomatic AL in patients following Lap LAR. Given the limitations of this study and the emergence of other novel biomarkers, multicenter prospective studies are worthy of further exploration.
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Affiliation(s)
- Xin-Yu Qi
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Fei Tan
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Mao-Xing Liu
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Kai Xu
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Pin Gao
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Zhen-Dan Yao
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Nan Zhang
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Hong Yang
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Cheng-Hai Zhang
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Jia-Di Xing
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Ming Cui
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
| | - Xiang-Qian Su
- Department of Gastrointestinal Surgery IV, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China
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12
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Bona D, Danelli P, Sozzi A, Sanzi M, Cayre L, Lombardo F, Bonitta G, Cavalli M, Campanelli G, Aiolfi A. C-reactive Protein and Procalcitonin Levels to Predict Anastomotic Leak After Colorectal Surgery: Systematic Review and Meta-analysis. J Gastrointest Surg 2023; 27:166-179. [PMID: 36175720 DOI: 10.1007/s11605-022-05473-z] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/04/2022] [Accepted: 09/16/2022] [Indexed: 02/01/2023]
Abstract
BACKGROUND Anastomotic leak (AL) is a feared complication after colorectal surgery. Prompt diagnosis and treatment are crucial. C-reactive protein (CRP) and procalcitonin (PCT) have been proposed as early AL indicators. The aim of this systematic review was to evaluate the CRP and CPT predictive values for early AL diagnosis after colorectal surgery. METHODS Systematic literature search to identify studies evaluating the diagnostic accuracy of postoperative CRP and CPT for AL. A Bayesian meta-analysis was carried out using a random-effects model and pooled predictive parameters to determine postoperative CRP and PCT cut-off values at different postoperative days (POD). RESULTS Twenty-five studies (11,144 patients) were included. The pooled prevalence of AL was 8% (95 CI 7-9%), and the median time to diagnosis was 6.9 days (range 3-10). The derived POD3, POD4 and POD5 CRP cut-off were 15.9 mg/dl, 11.4 mg/dl and 10.9 mg/dl respectively. The diagnostic accuracy was comparable with a pooled area under the curve (AUC) of 0.80 (95% CIs 0.23-0.85), 0.84 (95% CIs 0.18-0.86) and 0.84 (95% CIs 0.18-0.89) respectively. Negative likelihood ratios (LR-) showed moderate evidence to rule out AL on POD 3 (LR- 0.29), POD4 (LR- 0.24) and POD5 (LR- 0.26). The derived POD3 and POD5 CPT cut-off were 0.75 ng/ml (AUC = 0.84) and 0.9 ng/ml (AUC = 0.92) respectively. The pooled POD5 negative LR (-0.18) showed moderate evidence to rule out AL. CONCLUSIONS In the setting of colorectal surgery, CRP and CPT serum concentrations lower than the derived cut-offs on POD3-POD5, may be useful to rule out AL thus possibly identifying patients at low risk for AL development.
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Affiliation(s)
- Davide Bona
- Department of Biomedical Science for Health, Division of General Surgery, University of Milan, IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy
| | - Piergiorgio Danelli
- Department of Biomedical and Clinical Sciences, "Luigi Sacco" Hospital, University of Milan, Via Luigi Giuseppe Faravelli, n.16, 20149, Milan, Italy
| | - Andrea Sozzi
- Department of Biomedical Science for Health, Division of General Surgery, University of Milan, IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy
| | - Marcello Sanzi
- Department of Biomedical Science for Health, Division of General Surgery, University of Milan, IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy
| | - Luigi Cayre
- Department of Biomedical Science for Health, Division of General Surgery, University of Milan, IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy
| | - Francesca Lombardo
- Department of Biomedical Science for Health, Division of General Surgery, University of Milan, IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy
| | - Gianluca Bonitta
- Department of Biomedical Science for Health, Division of General Surgery, University of Milan, IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy
| | - Marta Cavalli
- Department of Surgery, University of Insubria, IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy
| | - Giampiero Campanelli
- Department of Surgery, University of Insubria, IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy
| | - Alberto Aiolfi
- Department of Biomedical Science for Health, Division of General Surgery, University of Milan, IRCCS Ospedale Galeazzi - Sant'Ambrogio, Milan, Italy.
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13
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The Significance of Blood and Peritoneal Fluid Biochemical Markers in Identifying Early Anastomotic Leak following Colorectal Resection-Findings from a Single-Center Study. MEDICINA (KAUNAS, LITHUANIA) 2022; 58:medicina58091253. [PMID: 36143930 PMCID: PMC9502513 DOI: 10.3390/medicina58091253] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/06/2022] [Revised: 09/01/2022] [Accepted: 09/08/2022] [Indexed: 11/18/2022]
Abstract
Background and Objectives: The aim of our study was to evaluate the value of leukocyte, C reactive protein (CRP), procalcitonin, lactate, and carcinoembryonic antigen (CEA) in blood and peritoneal fluid in early recognition of anastomotic leak (AL) after colorectal resections. Materials and Methods: Our pilot prospective cohort study was conducted at the abdominal surgery department at University Medical Center Ljubljana. A total of 43 patients who underwent open or laparoscopic colorectal resection because of benign or malignant etiology were enrolled. All of the patients had primary anastomosis without stoma formation. Results: Three patients in our patient group developed AL (7%). We found a statistically significant elevation of serum lactate levels in patients that developed AL compared to those who did not but noted no statistically relevant difference in the blood or peritoneal fluid levels of other biochemical markers. Conclusions: Elevated lactate levels may be considered a promising biomarker for the early diagnosis of AL, but more research on bigger patient groups is warranted.
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14
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Wang K, Li M, Liu R, Ji Y, Yan J. Analysis of Risk Factors for Anastomotic Leakage After Laparoscopic Anterior Resection of Rectal Cancer and Construction of a Nomogram Prediction Model. Cancer Manag Res 2022; 14:2243-2252. [PMID: 35928989 PMCID: PMC9343466 DOI: 10.2147/cmar.s364875] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/24/2022] [Accepted: 07/18/2022] [Indexed: 11/24/2022] Open
Abstract
Objective To explore the risk factors of anastomotic leakage (AL) after laparoscopic anterior resection (AR) of rectal cancer and establish a nomogram prediction model. Methods Clinical and surgical data of patients who underwent AR of rectal cancer at Sichuan Cancer Hospital from January 2017 to December 2020 were retrospectively collected. Univariate and multivariate logistic regression analyses were used to screen the independent risk factors of AL after AR. A nomogram risk prediction model was established based on the selected independent risk factors and the predictive performance of nomogram was evaluated. Results A 1013 patients undergoing laparoscopic AR were included, of which 67 had AL, with an incidence of 6.6%. Univariate and multivariate logistic regression analyses showed that male gender, tumors distance from the anus verge of ≤ 5cm, tumors distance from the anus verge of 5–10cm, circumferential tumor growth, operation time ≥ 240min, and no diverting stoma were independent risk factors for AL after AR. A nomogram prediction model was established based on these results. The calibration curve showed that the predicted occurrence probability of the nomogram model was in good agreement with the actual occurrence probability. The area under the receiver operating characteristic (ROC) curve was 0.749. Conclusion The nomogram prediction model based on the independent risk factors of patients undergoing AL after AR can effectively predict the probability of AL.
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Affiliation(s)
- Keli Wang
- Department of Clinical Medicine, Southwest Medical University, Luzhou, People’s Republic of China
| | - Meijiao Li
- Department of Clinical Medicine, Southwest Medical University, Luzhou, People’s Republic of China
| | - Rui Liu
- Department of Clinical Medicine, Southwest Medical University, Luzhou, People’s Republic of China
| | - Yang Ji
- Department of Clinical Medicine, University of Electronic Science and Technology of China, Chengdu, People’s Republic of China
| | - Jin Yan
- Department of Clinical Medicine, Southwest Medical University, Luzhou, People’s Republic of China
- Department of Gastrointestinal Surgery, Sichuan Cancer Hospital & Institute, Affiliated Cancer Hospital, School of Medicine, University of Electronic Science and Technology, Chengdu, People’s Republic of China
- Correspondence: Jin Yan, Email
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15
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The science of anastomotic healing. SEMINARS IN COLON AND RECTAL SURGERY 2022; 33. [DOI: 10.1016/j.scrs.2022.100879] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022]
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16
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Qi XY, Liu MX, Xu K, Gao P, Tan F, Yao ZD, Zhang N, Yang H, Zhang CH, Xing JD, Cui M, Su XQ. Peritoneal Cytokines as Early Biomarkers of Colorectal Anastomotic Leakage Following Surgery for Colorectal Cancer: A Meta-Analysis. Front Oncol 2022; 11:791462. [PMID: 35127496 PMCID: PMC8815457 DOI: 10.3389/fonc.2021.791462] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/08/2021] [Accepted: 12/28/2021] [Indexed: 11/26/2022] Open
Abstract
Background Postoperative colorectal anastomotic leakage (CAL) is a devastating complication following colorectal resection. However, the diagnosis of anastomotic leakage is often delayed because the current methods of identification are unable to achieve 100% clinical sensitivity and specificity. This meta-analysis aimed to evaluate the predictive value of peritoneal fluid cytokines in the detection of CAL following colorectal surgery. Methods A comprehensive search was conducted on PubMed, Embase, Cochrane Library, and Web of Science before June 2021 to retrieve studies regarding peritoneal fluid cytokines as early markers of CAL. Pooled analyses of interleukin (IL)-1β, IL-6, IL-10, and tumor necrosis factor (TNF) were performed. The means (MD) and standard deviations (SD) of the peritoneal fluid cytokines were extracted from the included studies. Review Manager Software 5.3 was used for data analysis. Results We included eight studies with 580 patients, among which 85 (14.7%) and 522 (44.5%) were evaluated as the CAL and non-CAL groups, respectively. Compared to the non-CAL group, the CAL group had significantly higher peritoneal IL-6 levels on postoperative day (POD) 1–3 (P = 0.0006, 0.0002, and 0.002, respectively) and slightly higher TNF levels on POD 4 (P = 0.0002). Peritoneal levels of IL-1β and IL-10 were not significantly different between the two groups in this study. Conclusion Peritoneal IL-6 levels can be a diagnostic marker for CAL following colorectal surgery, whereas the value of TNF needs further exploration in the future. Systematic Review Registration [https://www.crd.york.ac.uk/prospero/#myprospero], PROSPERO (CRD42021274973)
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Affiliation(s)
| | | | | | | | | | | | | | | | | | | | - Ming Cui
- *Correspondence: Xiang-Qian Su, ; Ming Cui,
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17
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Clark DA, Edmundson A, Steffens D, Harris C, Stevenson A, Solomon M. Drain fluid amylase as a biomarker for the detection of anastomotic leakage after rectal resection without a diverting ileostomy. ANZ J Surg 2022; 92:813-818. [PMID: 34994080 DOI: 10.1111/ans.17461] [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: 12/11/2021] [Accepted: 12/26/2021] [Indexed: 11/29/2022]
Abstract
BACKGROUND Anastomotic leak (AL) is the anathema of colorectal surgery. Early diagnosis is an essential segue to early intervention. A temporary diverting ileostomy (TDI) does not prevent an AL and presents inherent complications of its own. Numerous drain fluid biomarkers (BM) have been studied in colorectal surgery and extravasated intraluminal substances (EILS) such as amylase have shown promise. The aim of this study was to assess drain fluid amylase (DFA) as a BM of AL after minimally invasive rectal resection without a TDI. METHODS A single centre prospective cohort study performed from 2018 to 2021. The primary outcome was DFA measured daily whilst the drain was in situ. Rectal tube amylase was also measured for the first two post-operative days to quantitate the intra-luminal levels of the enzyme. DFA was compared between patients who experienced AL and those who did not. RESULTS Of the 62 patients studied, six (9.7%) experienced AL. There was a statistically significant difference in DFA between patients who experienced AL (Median:1373.5 U/L; IQR: 306-7953) and patients who did not experience an AL (Median: 27.0 U/L; IQR: 16-38); p < 0.0001. CONCLUSIONS The measurement of drain fluid amylase is a highly sensitive BM of early clinical anastomotic leak in patients undergoing a rectal resection with an extraperitoneal anastomosis and when a TDI is not incorporated. This simple, inexpensive and non-invasive test should be considered in all patients as an adjunct to the clinical diagnosis and differentiation of AL from other postoperative complications.
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Affiliation(s)
- David A Clark
- Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, New South Wales, Australia.,Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.,Department of Surgery, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.,Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.,Department of Surgery, St Vincent's Private Hospital Northside, Brisbane, Queensland, Australia
| | - Aleksandra Edmundson
- Department of Surgery, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.,Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia
| | - Daniel Steffens
- Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, New South Wales, Australia.,Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
| | - Craig Harris
- Department of Surgery, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.,Department of Surgery, St Vincent's Private Hospital Northside, Brisbane, Queensland, Australia
| | - Andrew Stevenson
- Department of Surgery, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.,Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.,Department of Surgery, St Vincent's Private Hospital Northside, Brisbane, Queensland, Australia
| | - Michael Solomon
- Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, New South Wales, Australia.,Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
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18
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Zhao Y, Li B, Sun Y, Liu Q, Cao Q, Li T, Li J. Risk Factors and Preventive Measures for Anastomotic Leak in Colorectal Cancer. Technol Cancer Res Treat 2022; 21:15330338221118983. [PMID: 36172641 PMCID: PMC9523838 DOI: 10.1177/15330338221118983] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022] Open
Abstract
Anastomotic leak (AL) represents one of the most detrimental complications after colorectal surgery. The patient-related factors and surgery-related factors leading to AL have been identified in previous studies. Through early identification and timely adjustment of risk factors, preventive measures can be taken to reduce potential AL. However, there are still many problems associated with AL. The debate about preventive measures such as preoperative mechanical bowel preparation (MBP), intraoperative drainage, and surgical scope also continues. Recently, the gut microbiota has received more attention due to its important role in various diseases. Although the underlying mechanisms of gut microbiota on AL have not been validated completely, new strategies that manipulate intrinsic mechanisms are expected to prevent and treat AL. Moreover, laboratory examinations for AL prediction and methods for blood perfusion assessment are likely to be promoted in clinical practice. This review outlines possible risk factors for AL and suggests some preventive measures in terms of patient, surgery, and gut microbiota.
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Affiliation(s)
- Yongqing Zhao
- 154454Department of General Surgery, The Second Hospital of Jilin University, Changchun, Jilin, China
| | - Bo Li
- 74569Department of Rehabilitation Medicine, China-Japan Union Hospital of Jilin University, Changchun, China
| | - Yao Sun
- 154454Department of General Surgery, The Second Hospital of Jilin University, Changchun, Jilin, China
| | - Qi Liu
- 154454Department of General Surgery, The Second Hospital of Jilin University, Changchun, Jilin, China
| | - Qian Cao
- 154454Department of Education, The Second Hospital of Jilin University, Changchun, Jilin, China
| | - Tao Li
- 154454Department of General Surgery, The Second Hospital of Jilin University, Changchun, Jilin, China
| | - Jiannan Li
- 154454Department of General Surgery, The Second Hospital of Jilin University, Changchun, Jilin, China
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19
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Shi J, Wu Z, Wu X, Shan F, Zhang Y, Ying X, Li Z, Ji J. OUP accepted manuscript. BJS Open 2022; 6:6601284. [PMID: 35657137 PMCID: PMC9165091 DOI: 10.1093/bjsopen/zrac069] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2021] [Revised: 04/13/2022] [Accepted: 04/13/2022] [Indexed: 12/03/2022] Open
Abstract
Background Anastomotic leakage (AL) is a severe complication after colorectal surgery. This study aimed to investigate a method for the early diagnosis of AL after surgical resection by analysing inflammatory factors (IFs) in peritoneal drainage fluid. Methods Abdominal drainage fluid of patients with colorectal cancer who underwent resection between April 2017 and April 2018, were prospectively collected in the postoperative interval. Six IFs, including interleukin (IL)-1β, IL-6, IL-10, tumour necrosis factor (TNF)-α, matrix metalloproteinase (MMP)2, and MMP9, in drainage were determined by multiplex immunoassay to investigate AL (in patients undergoing resection and anastomosis) and pelvic collection (in patients undergoing abdominoperineal resection). Sparreboom and colleagues’ prediction model was first evaluated for AL/pelvic collection, followed by a new IF-based score system (AScore) that was developed by a least absolute shrinkage and selection operator (LASSO) regression, for the same outcomes. The model performance was tested for the area under the curve (AUC), sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV). Results Out of 123 patients eligible, 119 patients were selected, including 12 patients with AL/pelvic collection. Sparreboom and colleagues’ prediction model was documented with the best diagnostic efficacy on postoperative day 3 (POD3), with an AUC of 0.77. After optimization, AScore on POD3 increased the AUC to 0.83 and on POD1 showed the best diagnostic efficiency, with an AUC of 0.88. Based on the Youden index, the cut-off value of AScore on POD1 was set as −2.46 to stratify patients into low-risk and high-risk groups for AL/pelvic collection. The model showed 90.0 per cent sensitivity, 69.7 per cent specificity, 98.4 per cent NPV, and 25.0 per cent PPV. Conclusions The early determination of IFs in abdominal drainage fluid of patients undergoing colorectal surgery could be useful to predict AL or pelvic collection.
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Affiliation(s)
- Jinyao Shi
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, P.R. China
| | - Zhouqiao Wu
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, P.R. China
| | - Xiaolong Wu
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, P.R. China
| | - Fei Shan
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, P.R. China
| | - Yan Zhang
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, P.R. China
| | - Xiangji Ying
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, P.R. China
| | - Ziyu Li
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, P.R. China
- Correspondence to: Ziyu Li, Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, No. 52 Fu-Cheng Road, Hai-Dian District, Beijing 100142, P.R. China (e-mail: ); Jiafu Ji, Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, No. 52 Fu-Cheng Road, Hai-Dian District, Beijing 100142, P.R. China (e-mail: )
| | - Jiafu Ji
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, P.R. China
- Correspondence to: Ziyu Li, Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, No. 52 Fu-Cheng Road, Hai-Dian District, Beijing 100142, P.R. China (e-mail: ); Jiafu Ji, Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, No. 52 Fu-Cheng Road, Hai-Dian District, Beijing 100142, P.R. China (e-mail: )
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20
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Reeves N, Vogel I, Ghoroghi A, Ansell J, Cornish J, Torkington J. Peritoneal cytokines as a predictor of colorectal anastomotic leaks on postoperative day 1: a systematic review and meta-analysis. Tech Coloproctol 2021; 26:117-125. [PMID: 34817744 DOI: 10.1007/s10151-021-02548-y] [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: 07/09/2021] [Accepted: 11/11/2021] [Indexed: 12/22/2022]
Abstract
BACKGROUND Anastomotic leakage (AL) is a major complication of colorectal surgery resulting in morbidity, mortality and poorer quality of life. The early diagnosis of AL is challenging due to the poor positive predictive value of tests available and reliance on clinical presentation which may be delayed. The aim of this systematic review was to assess the applicability of peritoneal cytokine levels as an early predictive test of AL in postoperative colorectal cancer patients. METHODS A comprehensive literature search was performed from inception to January 2021, in MEDLINE and EMBASE databases using MeSH and non-MeSH terms in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All studies evaluating peritoneal cytokines in the context of AL were included in this review. RESULTS Two hundred ninety-two abstracts were screened, 30 full manuscripts evaluated, and 12 prospective studies were included. There were 8 peritoneal cytokines evaluated (interleukin [IL]-1β, IL-6, IL-8, IL-10, vascular endothelial growth factor [VEGF], tumour necrosis factor alpha [TNF alpha] and matrix metalloproteinase [MMP]2 and MMP9) between AL and non-AL groups on postoperative day 1. Those that included IL-6 (7 studies), IL-10 (4 studies), TNF alpha (6 studies) and MMP9 (2 studies) were included in the meta-analysis. IL-10 was the only cytokine in the meta-analysis that was significantly (p < 0.05) raised in drain fluid on postoperative day 1 in AL patients. CONCLUSIONS Peritoneal IL-10 was significantly raised on postoperative day 1 in patients who subsequently developed AL. This may be a useful early predictor of AL and aid in an earlier diagnosis for postoperative colorectal patients. The range of cytokines investigated within the literature is limited and from heterogeneous studies which suggests more research is needed.
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21
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Clark DA, Steffens D, Solomon M. An umbrella systematic review of drain fluid analysis in colorectal surgery for the detection of anastomotic leak: Not yet ready to translate research studies into clinical practice. Colorectal Dis 2021; 23:2795-2805. [PMID: 34314559 DOI: 10.1111/codi.15844] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/21/2021] [Revised: 05/13/2021] [Accepted: 06/28/2021] [Indexed: 02/08/2023]
Abstract
AIM Anastomotic leak (AL) is the most important complication of intestinal surgery with an anastomosis. Whilst a number of studies have defined risk factors for AL, frustratingly, low-risk patients still develop AL. Studies have looked at drain fluid analysis for detection of AL, but these findings have failed to translate into routine clinical practice. This umbrella systematic review aims to provide an overview of the promising candidate biomarkers (BMs) that show potential to translate into clinical practice. METHODS A systematic literature search was conducted in MEDLINE, EMBASE, and the Cochrane, KSR Evidence and the Epistemonikos databases on the 14 April 2021. Only systematic reviews of cohort or controlled studies measuring drain fluid biomarkers in humans were included. The methodological quality of the reviews was assessed using the AMSTAR 2 instrument. Clinical trial registries were searched for trials actively investigating drain fluid BMs. Candidate BMs were classified, and threshold values investigated. RESULTS Nine systematic reviews, published between 2007 and 2020, met the inclusion criteria, and contained a total of 36 cohort studies. A total of 38 different BMs were studied. The most promising category of drain fluid BM was the extravasated intra-luminal substances (EILS) and five registered trials of these BMs were found. Two of nine reviews were of moderate quality. CONCLUSIONS The majority of BMs show inconsistent threshold values and are in the experimental stage. A number are not readily available for adoption into routine clinical practice. Most do not state a cut-off value to be considered as diagnostic.
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Affiliation(s)
- David A Clark
- Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, NSW, Australia.,Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, NSW, Australia.,Royal Brisbane and Women's Hospital, Brisbane, Qld, Australia.,University of Qld, St Lucia, Qld, Australia.,St Vincent's Private Hospital Northside, Brisbane, Qld, Australia
| | - Daniel Steffens
- Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, NSW, Australia.,Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, NSW, Australia
| | - Michael Solomon
- Faculty of Medicine and Health, Central Clinical School, The University of Sydney, Sydney, NSW, Australia.,Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, NSW, Australia
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22
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Galema HA, Meijer RPJ, Lauwerends LJ, Verhoef C, Burggraaf J, Vahrmeijer AL, Hutteman M, Keereweer S, Hilling DE. Fluorescence-guided surgery in colorectal cancer; A review on clinical results and future perspectives. Eur J Surg Oncol 2021; 48:810-821. [PMID: 34657780 DOI: 10.1016/j.ejso.2021.10.005] [Citation(s) in RCA: 43] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2021] [Accepted: 10/07/2021] [Indexed: 02/07/2023] Open
Abstract
BACKGROUND Colorectal cancer is the fourth most diagnosed malignancy worldwide and surgery is one of the cornerstones of the treatment strategy. Near-infrared (NIR) fluorescence imaging is a new and upcoming technique, which uses an NIR fluorescent agent combined with a specialised camera that can detect light in the NIR range. It aims for more precise surgery with improved oncological outcomes and a reduction in complications by improving discrimination between different structures. METHODS A systematic search was conducted in the Embase, Medline and Cochrane databases with search terms corresponding to 'fluorescence-guided surgery', 'colorectal surgery', and 'colorectal cancer' to identify all relevant trials. RESULTS The following clinical applications of fluorescence guided surgery for colorectal cancer were identified and discussed: (1) tumour imaging, (2) sentinel lymph node imaging, (3) imaging of distant metastases, (4) imaging of vital structures, (5) imaging of perfusion. Both experimental and FDA/EMA approved fluorescent agents are debated. Furthermore, promising future modalities are discussed. CONCLUSION Fluorescence-guided surgery for colorectal cancer is a rapidly evolving field. The first studies show additional value of this technique regarding change in surgical management. Future trials should focus on patient related outcomes such as complication rates, disease free survival, and overall survival.
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Affiliation(s)
- Hidde A Galema
- Department of Surgical Oncology and Gastrointestinal Surgery, Erasmus MC Cancer Institute, Doctor Molewaterplein 40, 3015, GD, Rotterdam, the Netherlands; Department of Otorhinolaryngology, Head and Neck Surgery, Erasmus MC Cancer Institute, Doctor Molewaterplein 40, 3015, GD, Rotterdam, the Netherlands
| | - Ruben P J Meijer
- Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, the Netherlands; Centre for Human Drug Research, Zernikedreef 8, 2333, CL, Leiden, the Netherlands
| | - Lorraine J Lauwerends
- Department of Otorhinolaryngology, Head and Neck Surgery, Erasmus MC Cancer Institute, Doctor Molewaterplein 40, 3015, GD, Rotterdam, the Netherlands
| | - Cornelis Verhoef
- Department of Surgical Oncology and Gastrointestinal Surgery, Erasmus MC Cancer Institute, Doctor Molewaterplein 40, 3015, GD, Rotterdam, the Netherlands
| | - Jacobus Burggraaf
- Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, the Netherlands; Centre for Human Drug Research, Zernikedreef 8, 2333, CL, Leiden, the Netherlands
| | - Alexander L Vahrmeijer
- Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, the Netherlands
| | - Merlijn Hutteman
- Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, the Netherlands
| | - Stijn Keereweer
- Department of Otorhinolaryngology, Head and Neck Surgery, Erasmus MC Cancer Institute, Doctor Molewaterplein 40, 3015, GD, Rotterdam, the Netherlands
| | - Denise E Hilling
- Department of Surgical Oncology and Gastrointestinal Surgery, Erasmus MC Cancer Institute, Doctor Molewaterplein 40, 3015, GD, Rotterdam, the Netherlands; Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, the Netherlands.
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23
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Shi J, Wu Z, Wu X, Shan F, Zhang Y, Ying X, Li Z, Ji J. Early Diagnosis of Anastomotic Leakage After Gastric Cancer Surgery Via Analysis of Inflammatory Factors in Abdominal Drainage. Ann Surg Oncol 2021; 29:1230-1241. [PMID: 34550478 DOI: 10.1245/s10434-021-10763-y] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2021] [Accepted: 08/21/2021] [Indexed: 12/14/2022]
Abstract
BACKGROUND Anastomotic leakage (AL) is the most serious postoperative complication for patients with gastric cancer. We aim to develop clinically tools to detect AL in the early phase by analysis of the inflammatory factors (IFs) in abdominal drainage. METHODS We prospectively included 326 patients to establish two independent cohorts, and the concentration of IFs within abdominal drainage was detected. In the primary cohort, an IF-based AL prediction model was constructed using the least absolute shrinkage and selection operator (LASSO) regression. The predictive value of the model was later validated via the validation cohort. RESULTS Analyzing the IFs with LASSO regression, we developed an Anastomotic Score system on postoperative Day 3 (AScore-POD3), which yielded high diagnostic efficacy in the primary cohort (the area under the curve (AUC) = 0.87). The predictive value of AScore-POD3 was validated in the validation cohort, and its AUC was 0.83. We further built an AScore-POD3 based nomogram by combining the AScore-POD3 system with other clinical risk factors of AL. The C-index of the nomogram was 0.93 in the primary cohort and 0.82 in the validation cohort. CONCLUSIONS Our study suggests that AL can be early diagnosed after gastric cancer surgery by measuring drainage IFs.
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Affiliation(s)
- Jinyao Shi
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, People's Republic of China
| | - Zhouqiao Wu
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, People's Republic of China
| | - Xiaolong Wu
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, People's Republic of China
| | - Fei Shan
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, People's Republic of China
| | - Yan Zhang
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, People's Republic of China
| | - Xiangji Ying
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, People's Republic of China
| | - Ziyu Li
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, People's Republic of China.
| | - Jiafu Ji
- Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, People's Republic of China.
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24
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Schwartz-Lasfargues C, Roux-Gendron C, Edomskis P, Marque I, Bayon Y, Lange JF, Faucheron JL, Trilling B. Early User Centred Design during development of an innovative medical device: case study of a connected Sensor System in colorectal surgery (Preprint). JMIR Hum Factors 2021; 9:e31529. [PMID: 35802406 PMCID: PMC9308077 DOI: 10.2196/31529] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/24/2021] [Revised: 02/23/2022] [Accepted: 03/21/2022] [Indexed: 11/13/2022] Open
Abstract
Background A successful innovative medical device is not only technically challenging to develop but must also be readily usable to be integrated into health care professionals’ daily practice. Through a user-centered design (UCD) approach, usability can be improved. However, this type of approach is not widely implemented from the early stages of medical device development. Objective The case study presented here shows how UCD may be applied at the very early stage of the design of a disruptive medical device used in a complex hospital environment, while no functional device is available yet. The device under study is a connected sensor system to detect colorectal anastomotic leakage, the most detrimental complication following colorectal surgery, which has a high medical cost. We also aimed to provide usability guidelines for the initial design of other innovative medical devices. Methods UCD was implemented by actively involving health care professionals and all the industrial partners of the project. The methodology was conducted in 2 European hospitals: Grenoble-Alpes University Hospital (France) and Erasmus Medical Center Rotterdam (the Netherlands). A total of 6 elective colorectal procedures and 5 ward shifts were observed. In total, 4 workshops were conducted with project partners and clinicians. A formative evaluation was performed based on 5 usability tests using nonfunctional prototype systems. The case study was completed within 12 months. Results Functional specifications were defined for the various components of the medical device: device weight, size, design, device attachment, and display module. These specifications consider the future integration of the medical device into current clinical practice (for use in an operating room and patient follow-up inside the hospital) and interactions between surgeons, nurses, nurse assistants, and patients. By avoiding irrelevant technical development, this approach helps to promote cost-effective design. Conclusions This paper presents the successful deployment over 12 months of a UCD methodology for the design of an innovative medical device during its early development phase. To help in reusing this methodology to design other innovative medical devices, we suggested best practices based on this case.
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Affiliation(s)
- Christel Schwartz-Lasfargues
- Public Health Department, CHU Grenoble Alpes, Grenoble, France
- Inserm CIC 1406, Université Grenoble Alpes, Grenoble, France
| | | | - Pim Edomskis
- Department of Surgery, Erasmus Medical Centre, Rotterdam, Netherlands
| | - Isabelle Marque
- Public Health Department, CHU Grenoble Alpes, Grenoble, France
- Inserm CIC 1406, Université Grenoble Alpes, Grenoble, France
| | - Yves Bayon
- Medtronic - Sofradim Production, Trevoux, France
| | - Johan F Lange
- Department of Surgery, Erasmus Medical Centre, Rotterdam, Netherlands
| | - Jean Luc Faucheron
- Colorectal Surgery Unit, Visceral Surgery and Acute Care Surgery Department, CHU Grenoble Alpes, Grenoble, France
- TIMC, Université Grenoble Alpes, Centre National de Recherche Scientifique, Grenoble INP, Grenoble, France
| | - Bertrand Trilling
- Colorectal Surgery Unit, Visceral Surgery and Acute Care Surgery Department, CHU Grenoble Alpes, Grenoble, France
- TIMC, Université Grenoble Alpes, Centre National de Recherche Scientifique, Grenoble INP, Grenoble, France
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25
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C-reactive protein can predict anastomotic leak in colorectal surgery: a systematic review and meta-analysis. Int J Colorectal Dis 2021; 36:1147-1162. [PMID: 33555423 DOI: 10.1007/s00384-021-03854-5] [Citation(s) in RCA: 33] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 01/21/2021] [Indexed: 02/04/2023]
Abstract
BACKGROUND Anastomotic leakage (AL) is one of the most significant complications after colorectal surgery, affecting length of stay, patient morbidity, mortality, and long-term oncological outcome. Serum C-reactive protein (CRP) level rises in infective and inflammatory states. Elevated CRP has been shown to be associated with anastomotic leak. OBJECTIVE Perform a meta-analysis of current CRP data in AL after colorectal surgery. DATA SOURCES MEDLINE, EMBASE, CINAHL, CENTRAL databases STUDY SELECTION: Comparative studies studying serum CRP levels in adult patients with and without AL after colorectal surgery. INTERVENTION(S) Elective and emergency open, laparoscopic or robotic colorectal excisions for cancer and benign pathology. MAIN OUTCOME MEASURES Mean serum CRP measurements between post-operative days (POD) 1 through 7 in patients with and without AL. Perform ROC analysis to determine cut-off CRP values to indicate AL. RESULTS Twenty-three studies with 6647 patients (482 AL). Pooled mean time to diagnosis of AL was 7.70 days. AL associated with higher CRP on POD1 (mean difference (MD) 15.19, 95% CI 5.88-24.50, p = 0.001), POD2 (MD 51.98, 05% CI 37.36-66.60, p < 0.00001), POD3 (MD 96.92, 95% CI 67.96-125.89, p < 0.00001), POD4 (MD 93.15, 95% CI 69.47-116.84, p < 0.00001), POD5 (MD 112.10, 95% CI 89.74-134.45, p < 0.00001), POD6 (MD 98.38, 95% CI 80.29-116.46, p < 0.00001), and POD7 (MD 106.41, 95% CI 75.48-137.35, p < 0.00001) compared with no AL. ROC analysis identified a cut-off CRP of 148 mg/l on POD3 with sensitivity and specificity of 95%. On POD4 through POD7, cut-off levels were 123 mg/l, 115 mg/l, 105 mg/l, and 96 mg/l, respectively, with sensitivity and specificity of 100%. LIMITATIONS Study heterogeneity, some characteristics unreported, no RCT CONCLUSIONS: AL is associated with higher CRP levels on each post-operative day compared to no AL after colorectal surgery. The cut-off CRP values can be used to predict AL to expedite investigation and treatment.
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26
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Edomskis P, Goudberg MR, Sparreboom CL, Menon AG, Wolthuis AM, D'Hoore A, Lange JF. Matrix metalloproteinase-9 in relation to patients with complications after colorectal surgery: a systematic review. Int J Colorectal Dis 2021; 36:1-10. [PMID: 32865714 PMCID: PMC7782374 DOI: 10.1007/s00384-020-03724-6] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/21/2020] [Indexed: 02/04/2023]
Abstract
PURPOSE Anastomotic leakage (AL) is the most severe complication following colorectal resection and is associated with increased mortality. The main group of enzymes responsible for collagen and protein degradation in the extracellular matrix is matrix metalloproteinases. The literature is conflicting regarding anastomotic leakage and the degradation of extracellular collagen by matrix metalloproteinase-9 (MMP-9). In this systematic review, the possible correlation between anastomotic leakage after colorectal surgery and MMP-9 activity is investigated. METHODS Embase, MEDLINE, Cochrane, and Web of Science databases were searched up to 3 February 2020. All published articles that reported on the relationship between MMP-9 and anastomotic leakage were selected. Both human and animal studies were found eligible. The correlation between MMP-9 expression and anastomotic leakage after colorectal surgery. RESULTS Seven human studies and five animal studies were included for analysis. The human studies were subdivided into those assessing MMP-9 in peritoneal drain fluid, intestinal biopsies, and blood samples. Five out of seven human studies reported elevated levels of MMP-9 in patients with anastomotic leakage on different postoperative moments. The animal studies demonstrated that MMP-9 activity was highest in the direct vicinity of an anastomosis. Moreover, MMP-9 activity was significantly reduced in areas further proximally and distally from the anastomosis and was nearly or completely absent in uninjured tissue. CONCLUSION Current literature shows some relation between MMP-9 activity and colorectal AL, but the evidence is inconsistent. Innovative techniques should further investigate the value of MMP-9 as a clinical biomarker for early detection, prevention, or treatment of AL.
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Affiliation(s)
- Pim Edomskis
- Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.
| | - Max R Goudberg
- Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands
| | - Cloë L Sparreboom
- Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands
| | - Anand G Menon
- Department of Surgery, IJsselland Ziekenhuis, Capelle aan den IJssel, The Netherlands
| | - Albert M Wolthuis
- Departmenf of Abdominal Surgery, University Hospital Leuven, Leuven, Belgium
| | - Andre D'Hoore
- Departmenf of Abdominal Surgery, University Hospital Leuven, Leuven, Belgium
| | - Johan F Lange
- Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands
- Department of Surgery, IJsselland Ziekenhuis, Capelle aan den IJssel, The Netherlands
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