RecruitingNCT06493565

Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage

Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage (REAL-study)

Sponsor

Amsterdam UMC, location VUmc

Enrollment

150 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

Anastomotic Leak Rectum

Summary

The objective of this international prospective observational study is to evaluate the implementation of a point-of-care digital rectoscope (LumenEye) into routine care to detect colorectal anastomotic leakage in the early postoperative period. The study includes patients undergoing a colorectal resection with colorectal or coloanal anastomosis ≤15 centimeters from the anorectal junction. The participating centers consist of expert colorectal units in various countries. The primary endpoint for the study is the time to diagnosis of anastomotic leakage.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether routinely using an endoscope (a flexible camera) to check the bowel connection (anastomosis) after colorectal surgery can detect leaks earlier and lead to better patient outcomes. **You may be eligible if...** - You are 18 or older - You recently had surgery to remove part of the colon or rectum, and a new bowel connection was made within 15 cm of the anal opening - You are able to understand the study language and provide written consent **You may NOT be eligible if...** - You are unable to get into the required position for the camera examination (lying on your left side) - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERoutine endoscopic anastomosis inspection

The routine care pathway for early detection of anastomotic leakage includes: * C-reactive protein guided imaging * Rectoscopy of the anastomosis three to six days after surgery * Rectoscopy of the anastomosis two to three weeks after surgery

Locations(5)

Bordeaux Colorectal Institute Academy

Bordeaux, France

Humanitas Research Hospital

Milan, Italy

Amsterdam UMC

Amsterdam, Netherlands

University Hospital Vall D'Hebron

Barcelona, Spain

Imperial College London

London, United Kingdom

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NCT06493565