Actively Recruiting
Randomized Trial Comparing Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Transrectal Specimen Retrieval
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
1
Participants Needed
1
Research Sites
808 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. Most patients can be included within a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the specimen is retrieved within an endobag through the rectum. The anastomosis is created intracorporeally using a triple stapled technique. There are no trials available in the literature concerning these 2 techniques. Therefore this study will be undertaken to establish the role of the 2 surgical procedures and to compare them after short-term follow-up.
CONDITIONS
Official Title
Randomized Trial Comparing Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Transrectal Specimen Retrieval
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 90 years
- Symptomatic recurrent diverticular disease
- Benign adenomatous polyp requiring surgery
- Early non-transmural sigmoid tumor
- Signed written informed consent approved by ethical committee
You will not qualify if you...
- Patients unsuitable for laparoscopy
- Pregnancy
- ASA classification greater than III
- Coagulation disorders
- Use of anti-coagulants
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospitals Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
A
Albert M Wolthuis, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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