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RECRUITINGINTERVENTIONAL

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

A Phase III Randomized Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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: blood count (hemoglobin) at least 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 weakened immune system and/or under corticotherapy; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 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.

Treatments Being Tested

PROCEDURE

Tailored use of defunctioning stoma after TME

Tailored use of defunctioning stoma after TME based on a 2-step process: i) to perform or not a defunctioning stoma according to the personalized risk of anastomotic leakage (defunctioning stoma only if Anastomotic Failure Observed Risk Score=\[2-6\]), ii) to perform an early stoma closure at day 8-12, according to clinical (fever), biological (CRP level days 2 and 4 postoperatively) and radiological postoperative assessment (CT-scan with colonic contrast retrograde enema day 7-8 postoperatively)

PROCEDURE

Systematic use of defunctioning stoma

Systematic use of defunctioning stoma for 2-3 months after TME, according to French national and international guidelines

Locations (20)

CHU Amiens-Picardie - Service de Chirurgie Digestive
Amiens, France
CHRU de Besançon - Service de Chirurgie Générale, Digestive et Cancérologique - Unité de Transplantation Hépatique
Besançon, France
CHU de Bordeaux - Service de Chirurgie Digestive et Endocrinienne - Unité Colorectale
Bordeaux, France
Clinique Tivoli Ducos - Service de Chirurgie Digestive
Bordeaux, France
CHU de Clermont-Ferrand - Service de Chirurgie Digestive et Hépato-biliaire
Clermont-Ferrand, France
APHP - Hôpital Beaujon - Service de Chirurgie Digestive
Clichy, France
CHU Grenoble Alpes - Service de Chirurgie Digestive
La Tronche, France
APHP - Hôpital Bicêtre - Service de Chirurgie Générale et Digestive
Le Kremlin-Bicêtre, France
CHU de Lille - Service de Chirurgie Générale et Digestive
Lille, France
Centre Lyonnais de Chirurgie Digestive
Lyon, France
APHM - Hôpital La Timone - Service de Chirurgie Digestive et Générale
Marseille, France
APHM - Hôpital Nord - Service de Chirurgie Digestive
Marseille, France
Hôpital Européen de Marseille - Service de Chirurgie Digestive
Marseille, France
Institut Paoli Calmette - Service de Chirurgie Digestive
Marseille, France
Institut du Cancer de Montpellier - Service de Chirurgie Digestive
Montpellier, France
APHP - HEGP- Service de Chirurgie Digestive
Paris, France
APHP - Hôpital Saint Antoine - Service de Chirurgie Digestive
Paris, France
APHP - Hôpital Saint-Louis - Service de Chirurgie Viscérale, Cancérologique et Endocrinienne
Paris, France
GH Diaconesses Croix Saint-Simon - Service de Chirurgie Digestive
Paris, France
Groupe Hospitalier Paris St. Joseph - Service de Chirurgie Digestive et Obésité
Paris, France