IMARI: multi-Interventional program for prevention and early Management of Anastomotic leakage after low anterior resection in Rectal cancer patIents: rationale and study protocol

Abstract Background Anastomotic leakage (AL) is still a common and feared complication after low anterior resection (LAR) for rectal cancer. The multifactorial pathophysiology of AL and lack of standardised treatment options requires a multi-modal approach to improve long-term anastomotic integrity. The objective of the IMARI-trial is to determine whether the one-year anastomotic integrity rate in patients undergoing LAR for rectal cancer can be improved using a multi-interventional program. Methods IMARI is a multicentre prospective clinical effectiveness trial, whereby current local practice (control cohort) will be evaluated, and subsequently compared to results after implementation of the multi-interventional program (intervention cohort). Patients undergoing LAR for rectal cancer will be included. The multi-interventional program includes three preventive interventions (mechanical bowel preparation with oral antibiotics, tailored full splenic flexure mobilization and intraoperative fluorescence angiography using indocyanine green) combined with a standardised pathway for early detection and active management of AL. The primary outcome is anastomotic integrity, confirmed by CT-scan at one year postoperatively. Secondary outcomes include incidence of AL, protocol compliance and association with AL, temporary and permanent stoma rate, reintervention rate, quality of life and functional outcome. Microbiome analysis will be conducted to investigate the role of the rectal microbiome in AL. In a Dutch nationwide study, the AL rate was 20%, with anastomotic integrity of 90% after one year. Based on an expected reduction of AL due to the preventive approaches of 50%, and increase of anastomotic integrity by a standardised pathway for early detection and active management of AL, we hypothesised that the anastomotic integrity rate will increase from 90 to 97% at one year. An improvement of 7% in anastomotic integrity at one year was considered clinically relevant. A total number of 488 patients (244 per cohort) are needed to detect this difference, with 80% statistical power. Discussion The IMARI-trial is designed to evaluate whether a multi-interventional program can improve long-term anastomotic integrity after rectal cancer surgery. The uniqueness of IMARI lies in the multi-modal design that addresses the multifactorial pathophysiology for prevention, and a standardised pathway for early detection and active treatment of AL. Trial registration Trialregister.nl (NL8261), January 2020.

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High Risk of Low Anterior Resection Syndrome in Long-term Follow-up after Anastomotic Leakage in Anterior Resection for Rectal Cancer

Diseases of the Colon & Rectum ◽

10.1097/dcr.0000000000002334 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Henrik Jutesten ◽

Pamela Buchwald ◽

Eva Angenete ◽

Martin Rutegård ◽

Marie-Louise Lydrup

Keyword(s):

Rectal Cancer ◽

High Risk ◽

Anastomotic Leakage ◽

Anterior Resection ◽

Low Anterior Resection ◽

Low Anterior Resection Syndrome ◽

Anterior Resection Syndrome ◽

Long Term Follow Up

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Long term outcome of anastomotic leakage in patients undergoing low anterior resection for rectal cancer

BMC Cancer ◽

10.1186/s12885-020-07109-4 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Alice Artus ◽

Nicolas Tabchouri ◽

Othman Iskander ◽

Nicolas Michot ◽

Olivier Muller ◽

...

Keyword(s):

Rectal Cancer ◽

Anastomotic Leakage ◽

Anterior Resection ◽

Low Anterior Resection ◽

Term Outcome ◽

Long Term Outcome

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Risk factors of symptomatic anastomotic leakage and its impacts on a long-term survival after laparoscopic low anterior resection for rectal cancer: a retrospective single-center study

World Journal of Surgical Oncology ◽

10.1186/s12957-021-02303-5 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Xinyu Qi ◽

Maoxing Liu ◽

Kai Xu ◽

Pin Gao ◽

Fei Tan ◽

...

Keyword(s):

Risk Factors ◽

Rectal Cancer ◽

Anastomotic Leakage ◽

Anterior Resection ◽

Low Anterior Resection ◽

Term Survival ◽

Long Term Survival ◽

Prolonged Duration ◽

Duration Of Operation

Abstract Background Postoperative symptomatic anastomotic leakage (AL) is a serious complication after low anterior resection (LAR) for rectal cancer. AL can potentially affect short-term patient outcomes and long-term prognosis. This study aimed to explore the risk factors and long-term survival of symptomatic AL after laparoscopic LAR for rectal cancer. Methods From May 2009 to May 2015, 298 consecutive patients who underwent laparoscopic LAR for rectal cancer with or without a defunctioning stoma were included in this study. Univariate and multivariate logistic regression analyses were used to explore independent risk factors for symptomatic AL. Survival analysis was performed using Kaplan–Meier curves, and log-rank tests were used for group comparisons. Results Among the 298 patients enrolled in this study, symptomatic AL occurred in eight (2.7%) patients. The univariate analysis showed that age of ≤65 years (P = 0.048), neoadjuvant therapy (P = 0.095), distance from the anal verge (P = 0.078), duration of operation (P = 0.001), and pathological tumor (T) category (P = 0.004) were associated with symptomatic AL. The multivariate analysis demonstrated that prolonged duration of operation (P = 0.010) was an independent risk factor for symptomatic AL after laparoscopic LAR for rectal cancer. No statistically significant differences were observed in the 3-year (P = 0.785) and 5-year (P = 0.979) overall survival rates. Conclusions A prolonged duration of operation increased the risk of symptomatic AL after laparoscopic LAR for rectal cancer. An impact of symptomatic AL on a long-term survival was not observed in this study; however, further studies are required. Trial registration This study was registered in the Chinese Clinical Trial Registry (ChiCTR2000033413) on May 31, 2020.

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Risk Factors of Symptomatic Anastomotic Leakage and its Impacts on Long Term Survival after Laparoscopic Low Anterior Resection for Rectal Cancer: A Retrospective Single Center Study

10.21203/rs.3.rs-169861/v1 ◽

2021 ◽

Author(s):

Xinyu Qi ◽

Maoxing Liu ◽

Kai Xu ◽

Pin Gao ◽

Fei Tan ◽

...

Keyword(s):

Risk Factors ◽

Rectal Cancer ◽

Survival Analysis ◽

Anastomotic Leakage ◽

Anterior Resection ◽

Low Anterior Resection ◽

Term Survival ◽

Long Term Survival ◽

Duration Of Operation

Abstract Background: Postoperative symptomatic anastomotic leakage (AL) is a serious complication after low anterior resection (LAR) for rectal cancer. AL can potentially affect short-term patient outcomes and long-term prognosis. This study aimed to explore the risk factors and long-term survival of symptomatic AL after laparoscopic LAR for rectal cancer.Methods: From May 2009 to May 2015, 298 consecutive patients who underwent laparoscopic LAR for rectal cancer with or without a defunctioning stoma were included in this study. Univariate and multivariate logistic regression analyses were used to explore independent risk factors for symptomatic AL. Survival analysis was performed using Kaplan–Meier curves, and log-rank tests were used for group comparisons.Results: Among the 298 patients enrolled in this study, symptomatic AL occurred in eight patients (2.7%). The univariate analyses showed that the age≤65 (P = 0.048), neoadjuvant therapy (P = 0.095), distance from the anal verge (P = 0.078), duration of operation (P = 0.001), and pathological tumor (T) category (P = 0.004) were associated with symptomatic AL. The multivariate analysis demonstrated that only the duration of operation (P = 0.010) was an independent risk factor for symptomatic AL after laparoscopic LAR for rectal cancer. In the survival analysis, no statistically significant differences in the 3-year (P = 0.785) and 5-year (P = 0.979) overall survival rates were observed.Conclusions: A prolonged duration of operation increased the risk of symptomatic AL after laparoscopic LAR for rectal cancer. An impact of symptomatic AL on long-term survival was not observed in this study, but it needs to be studied more.Trial registration: This study was registered in the Chinese Clinical Trial Registry (ChiCTR2000033413).

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Long-term oncological outcomes of low anterior resection for rectal cancer with and without preservation of the left colic artery: a retrospective cohort study

BMC Cancer ◽

10.1186/s12885-021-07848-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Yuwen Luo ◽

Rongjiang Li ◽

Deqing Wu ◽

Jun Zeng ◽

Junjiang Wang ◽

...

Keyword(s):

Rectal Cancer ◽

Anastomotic Leakage ◽

Anterior Resection ◽

Low Anterior Resection ◽

Colic Artery ◽

Early Complications ◽

Left Colic Artery ◽

Oncological Outcomes

Abstract Background There is uncertainty in the literature about preserving the left colic artery (LCA) during low anterior resection for rectal cancer. We analyzed the effect of preserving the LCA on long-term oncological outcomes. Methods We retrospectively collected clinicopathological and follow-up details of patients who underwent low anterior resection for rectal cancer in the General Surgery Department of Guangdong Provincial People’s Hospital, from January 2014 to December 2015. Cases were divided into low ligation (LL), LCA preserved, or high ligation (HL), LCA not preserved, of the inferior mesenteric artery. The 5-year overall survival (OS) and disease-free survival (DFS) rates were compared between the two groups. Results Altogether, there were 221 and 295 cases in the LL group and HL groups, respectively. Operating time in the LL group was significantly longer than in the HL group (224.7 vs. 211.7 min, p = 0.039). Postoperative 30-day mortality, early complications including anastomotic leakage showed no significant differences between the LL and HL groups (postoperative 30-day mortality, 0.9% LL, 1.4% HL, p = 0.884; early complications, 41.2% LL, 38.3% HL, p = 0.509; anastomotic leakage 8.6% LL, 13.2% HL, p = 0.100). The median follow-up periods were 51.4 (7–61) months in the LL group and 51.2 (8–61) months in the HL group. During follow-up, the percentages of patients who died, had local recurrence, or had metastases were 39.8, 7.7, and 38.5%, respectively, in the LL group and 39, 8.5, and 40%, respectively, in the HL group; these differences were not significant (all p > 0.05). The 5-year OS and DFS were 69.6 and 59.6% in the LL group, respectively, and 69.1 and 56.2% in the HL group, respectively; these differences were not significant (all p > 0.05). After stratification by tumor-node-metastasis stage, the difference between the 5-year OS and DFS for stages I, II, and III cancer were not significant (all p > 0.05). Conclusions The long-term oncological outcomes of LL group are comparable with HL group. LL cannot be supported due to the absence of lower complication rates and the longer operating times.

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