Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)
- Sponsor
- Bordeaux Colorectal Institute
- Study ID
- NCT07146334
- Status
- Not Yet Recruiting
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Conditions
- Rectal Cancer
- Surgery Indication
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
The objectiive of this prospective, international cohort is to compare two anastomotic techniques (DS vs TTSS) by collecting data during the surgery, and postoperatively (morbidity and functional outcomes). The choice of technique is left to the discretion of the surgeon based on her/his practices.
Key Dates
- First listed
- Aug 28, 2025
- Start date
- Sep 30, 2025
- Status verified
- Jul 2025
- Primary completion
- Sep 30, 2029
- Completion
- Sep 30, 2029
Study Design
- Enrollment
- 400 participants (estimated)
Arms
- Arm: Rectal surgery with powered mechanical anastomosis performed with DS or TTSS techniquesThis is an international cohort (France and other international centers) which consists of including patients undergoing rectal surgery with powered mechanical anastomosis performed with DS or TTSS techniques. Surgeons at each center perform one or both techniques. When both types of stapling are possible, the choice of technique is made by the surgeon during the preoperative consultation, in the best interest of the patients, after a case-by-case assessment.
Primary Outcome Measure
To assess and compare the rate of anastomotic leakage at 1 month after rectal excision between double and single-stapling low colorectal anastomosis using advanced powered stapler [ Time Frame: From the surgery to one month ]
Central Contacts
- Quentin QD DENOST, Prof+ 33 (0)5 47 50 15 75
- Hélène HMM MAILLOU-MARTINAUD, CRA+33 6 68 68 68 05
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