Clinical Trial

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

Study acronym: REAL
Unknown
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Record status
This record was last updated July 10, 2024 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06493565
Lead Sponsor Amsterdam UMC, location VUmc
Conditions Anastomotic Leak Rectum
Enrollment 150 participants
Start Date 2024-05-01
Primary Completion 2026-05 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2024-07-10