Actively Recruiting
Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage
Led by Amsterdam UMC, location VUmc · Updated on 2024-07-10
150
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Underwent open or minimally invasive sphincter-preserving surgery with colorectal or coloanal anastomosis within 15 centimeters from the anorectal junction
- Adequate comprehension of the country-specific language or English
- Provided written informed consent
You will not qualify if you...
- Unable to lie on the left side for anorectal endoscopic examination
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Bordeaux Colorectal Institute Academy
Bordeaux, France
Not Yet Recruiting
2
Humanitas Research Hospital
Milan, Italy
Not Yet Recruiting
3
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
4
University Hospital Vall D'Hebron
Barcelona, Spain
Not Yet Recruiting
5
Imperial College London
London, United Kingdom
Not Yet Recruiting
Research Team
R
Roel Hompes, MD PhD
CONTACT
D
David Nijssen, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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