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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc

About this trial

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 criteria

Qualifiers

≥ 18 years of age

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.

Adequate comprehension of the country specific or English language

Written informed consent

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Routine endoscopic anastomosis inspection

Treatment groups

No treatment groups listed

Sponsors and collaborators