Multi-Interventional program for prevention and early Management of Anastomotic leakage after total mesorectal excision in Rectal cancer patIents, the IMARI-trial
- Conditions
- Anastomotic leakage after rectal cancer surgery
- Registration Number
- NL-OMON26456
- Lead Sponsor
- Prof. dr. P.J. Tanis, Surgeon, Academic Medical Center, University of Amsterdam, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 488
Inclusion Criteria
1) Patients with a diagnosis of primary rectal cancer with the lower border below the level of the sigmoid take-off on MRI, or regrowth in a watch and wait protocol, or undergoing completion/salvage surgery after local excision;
2) Age above 18;
3) Able to fill in questionnaires in Dutch and to come to out-patient-clinic visits;
4) Written informed consent.
Exclusion Criteria
1) Patients not undergoing resection with colo-rectal/anal anastomosis;
2) Local recurrent rectal cancer;
3) Locally advanced rectal cancer requiring extended or multi-visceral excision;
4) Synchronous colonic resections;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the IMARI-trial is anastomotic integrity at one year postoperative.
- Secondary Outcome Measures
Name Time Method The most important secondary aim is to determine the impact on the incidence of AL within 30 and 90 days and one year post-operation. Other outcomes include quality of life, protocol compliance, changes in rectal microbiome, FA details and other postoperative outcomes.