Status:
RECRUITING
Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Anastomotic Leak Rectum
Eligibility:
All Genders
18+ years
Brief 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 anastomoti...
Detailed Description
Anastomotic leakage (AL) following colorectal surgery may occur in up to 20% of patients. Treatment success for AL largely depends on its timely initiation. Relatedly, early diagnosis can avoid severe...
Eligibility Criteria
Inclusion
- ≥ 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
Exclusion
- 1\. Inability to adopt the required positioning for anorectal endoscopic examination (i.e. left lateral position)
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06493565
Start Date
May 1 2024
End Date
May 1 2026
Last Update
July 10 2024
Active Locations (5)
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1
Bordeaux Colorectal Institute Academy
Bordeaux, France
2
Humanitas Research Hospital
Milan, Italy
3
Amsterdam UMC
Amsterdam, Netherlands
4
University Hospital Vall D'Hebron
Barcelona, Spain