Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage
NCT06493565
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
Inclusion Criteria: 1. ≥ 18 years of age 2. The participant underwent an open or minimally invasive, sphincter preserving surgery with the construction of a colorectal or coloanal anastomosis ≤15 centimetres from the anorectal junction. 3. Adequate comprehension of the country specific or English language 4. Written informed consent Exclusion Criteria: 1\. Inability to adopt the required positioning for anorectal endoscopic examination (i.e. left lateral position)
Conditions2
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NCT06493565