IMARI: multi-Interventional program for prevention and early Management of Anastomotic leakage after low anterior resect
- PDF / 1,196,268 Bytes
- 10 Pages / 595.276 x 790.866 pts Page_size
- 3 Downloads / 192 Views
STUDY PROTOCOL
Open Access
IMARI: multi-Interventional program for prevention and early Management of Anastomotic leakage after low anterior resection in Rectal cancer patIents: rationale and study protocol M. D. Slooter1†, K. Talboom1*† , S. Sharabiany1, C. P. M. van Helsdingen1, S. van Dieren1, C. Y. Ponsioen2, C. Y. Nio3, E. C. J. Consten4, J. H. Wijsman5, M. A. Boermeester1, J. P. M. Derikx6, G. D. Musters1, W. A. Bemelman1, P. J. Tanis1, R. Hompes1* and on behalf of the IMARI-study group
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 (Continued on next page)
* Correspondence: [email protected]; [email protected] † M. D. Slooter and K. Talboom contributed equally to this work. 1 Department of Surgery, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third part
Data Loading...
