Status:
NOT_YET_RECRUITING
Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)
Lead Sponsor:
Bordeaux Colorectal Institute
Conditions:
Rectal Cancer
Surgery Indication
Eligibility:
All Genders
18+ years
Brief Summary
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 outc...
Detailed Description
There are a variety of available anastomotic techniques to facilitate restorative surgery following total mesorectal excision (TME) for rectal cancer. However, there is no good quality evidence demons...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Patients with rectal cancer lower than 12 cm from the anal verge requiring either a stapling anastomosis below 7 cm from the anal verge,
- Patients with powered mechanical anastomosis (INTOCARE devices)
- Patients with no metastasis
- Patients operated on by mini-invasive rectal excision (laparoscopic, robotic or TaTME);
- Patients with or without defunctioning ileostomy;
- Patients with or without neoadjuvant treatment;
- Patient who benefits by medicare system;
- Signed and dated informed consent
Exclusion
- Patients with handsewn anastomosis
- Patients with perforated rectal cancer or preoperative pelvic sepsis ;
- Patients with inflammatory bowel disease;
- Patients operated on in emergency ;
- Patients with extended-TME or pelvic exenteration;
- Pregnancy or breast feeding period
- Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study
- Persons deprived of liberty or under guardianship
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07146334
Start Date
September 1 2025
End Date
September 1 2029
Last Update
August 28 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Universitaire de Belgique
Leuven, Belgium
2
Hôpital Universitaire McGill
Montreal, Canada
3
CHU de Quebec
Québec, Canada
4
Hôpital Universitaire de Shanghai
Shanghai, China