ArticleBMC surgery2020
IMARI: multi-Interventional program for prevention and early Management of Anastomotic leakage after low anterior resection in Rectal cancer patIents: rationale and study protocol.
Article in BMC surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed, 19 citations in OpenAlex.
- Perioperative faecal microbiome dynamics in patients undergoing rectal cancer surgery in the IMARI-trial.BJS open · 2026Article
- The perioperative microbiome of patients undergoing rectal cancer surgery: A pilot study.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2026Article
- Complete prevention of anastomotic leakage using total enteric flow diversion.World journal of gastrointestinal surgery · 2025Article
- Hospital costs of different treatment strategies for anastomotic leakage after total mesorectal excision: a multicentre cost analysis.Techniques in coloproctology · 2025Article
- Anastomotic tension "Bridging": a risk factor for anastomotic leakage following low anterior resection.Surgical endoscopy · 2024Article
- Stoma-free survival after anastomotic leak following rectal cancer resection: worldwide cohort of 2470 patients.The British journal of surgery · 2023Article
- Comparison of proactive and conventional treatment of anastomotic leakage in rectal cancer surgery: a multicentre retrospective cohort series.Techniques in coloproctology · 2023Article
- Diverting stomas reduce reoperation rates for anastomotic leak but not overall reoperation rates within 30 days after anterior rectal resection: a national cohort study.International journal of colorectal disease · 2022Article
- The impact of prolonged delay to loop ileostomy closure on postoperative morbidity and hospital stay: A retrospective cohort study.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2022Review
- Surgical Treatment of Low-Lying Rectal Cancer: Updates.Annals of coloproctology · 2021Review
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Authors and funding
16 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundAnastomotic 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.
methodsIMARI 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 registrationTrialregister.nl ( NL8261 ), January 2020.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.