Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesore… (NCT05233787) | Clinical Trial Compass
UnknownNot Applicable
Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
France212 participantsStarted 2022-03-24
Plain-language summary
GRECCAR 17 will be the first prospective and randomized trial to assess a tailored policy in the use of defunctioning stoma after TME according to the personalized risk of anastomotic leakage. The tailored use of defunctioning stoma after TME for rectal cancer should improve both the quality of life of patients and the anorectal function, without any impact on anastomotic leakage. Moreover, for the healthcare system, this new approach could be a cost-effective strategy, leading to a decrease in healthcare expenses.
The main objective is to compare the impact of tailored defunctioning stoma after TME for rectal cancer versus the systematic use of defunctioning stoma on the evolution of the specific Quality Of Life (QLQC30) during the 12 months after surgery.
Who can participate
Age range
18 Years – 80 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 18-80 years;
* Rectal adenocarcinoma (histologically proven)
* No metastasis or medical history of colorectal metastasis (M0)
* Patients with rectal cancer \< 12 cm from the anal verge (determined by rectal examination or MRI)
* Patients operated on by mini-invasive TME (laparoscopic, robotic or TaTME);
* With or without neo adjuvant treatment
* Realize a stapling anastomosis \< 7 cm from the anal verge (determined by rectal examination or MRI)
* Patients with expected defunctioning ileostomy
* Appropriate hematologic function: hemoglobin ≥ 10.5 g/dL, leukocytes \> 4000/mm3, blood platelets \> 100,000/mm3);
* Appropriate renal function (serum creatinine \< 15 mg/dL);
* Effective contraception of childbearing age : Male patients and premenopausal women should agree to use two medically validated contraceptive methods (one for the patient et one for the partner) during the study
* Patient affiliated or beneficiary to a health security system;
* Patient and doctor have signed informed consent
Exclusion Criteria:
* Patients with rectal cancer requiring TME surgery with handsewn anastomosis;
* Patients operated on by open approach;
* Previous pelvic irradiation for reasons other than rectal cancer
* Concomitant cancer or medical history of cancer within 5 years other than cancers treated in situ (cervical carcinoma or basocellular carcinoma or spinocellular carcinoma)
* Patients with expected defunctioning colostomy;
* Patients with perforated rectal c…
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.