Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)

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 rectalexamination 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 rectalexamination 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 womenshould agree to use two medically validated contraceptive methods (one for thepatient 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 cancerstreated in situ (cervical carcinoma or basocellular carcinoma or spinocellularcarcinoma)

• 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 postoperativeQOL;

• Pregnancy or breast feeding;

• Persons deprived of liberty or under guardianship (curatorship or tutorship) orincapable of giving consent;

• Any psychological, familial, sociological or geographical condition potentiallyhampering compliance with the study protocol or follow-up scheduled.