Status:
RECRUITING
Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Rectal Cancer
Ileostomy; Functional Disturbance
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 tai...
Detailed Description
The introduction of Total Mesorectal Excision (TME) as the surgical procedure of choice for low and mid rectal cancer has led to decrease local recurrence and improved oncological results. Postoperati...
Eligibility Criteria
Inclusion
- 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
- 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 cancer or preoperative pelvic sepsis;
- Patients with inflammatory bowel disease and/or bowel obstruction,
- Patients operated on in emergency;
- Patients with poor nutrition (Albumin \< 34 g/L, pre-Alb \< 0.14 g/L)
- Patients with extended-TME or pelvic exenteration (prostate);
- Patients with history of heart or vascular ischemia;
- Severe heart disease or congestive heart disease;
- Patients with immunodeficiency and/or under corticotherapy;
- Severe lung disease or respiratory failure;
- Severe kidney disease;
- Previous disease or disability expected to influence the assessment of postoperative QOL;
- Pregnancy or breast feeding;
- Persons deprived of liberty or under guardianship (curatorship or tutorship) or incapable of giving consent;
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up scheduled.
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT05233787
Start Date
March 24 2022
End Date
September 1 2025
Last Update
May 16 2024
Active Locations (28)
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1
CHU Amiens-Picardie - Service de Chirurgie Digestive
Amiens, France
2
CHRU de Besançon - Service de Chirurgie Générale, Digestive et Cancérologique - Unité de Transplantation Hépatique
Besançon, France
3
CHU de Bordeaux - Service de Chirurgie Digestive et Endocrinienne - Unité Colorectale
Bordeaux, France
4
Clinique Tivoli Ducos - Service de Chirurgie Digestive
Bordeaux, France