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Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage
Sponsor: Amsterdam UMC, location VUmc
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.
Official title: Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage (REAL-study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2024-05-01
Completion Date
2026-05
Last Updated
2024-07-10
Healthy Volunteers
Not specified
Conditions
Interventions
Routine 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