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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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