Informations générales (source: ClinicalTrials.gov)
A Phase III Randomized Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
Interventional
N/A
University Hospital, Bordeaux (Voir sur ClinicalTrials)
mars 2022
septembre 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | L�onor BENHAIM | 16/02/2024 12:43:31 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Beaujon | Yves PANIS | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Jérémie LEFEVRE | Contact (sur clinicalTrials) | |||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Thierry BENSIGNOR | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Nancy - Service de Chirugie Digestive, Hépatobiliaire, endocrinienne et Cancérologique - Vandœuvre-lès-Nancy - France | Adeline GERMAIN | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM - Hôpital La Timone - Service de Chirurgie Digestive et Générale - Marseille - France | Diane MEGE | Contact (sur clinicalTrials) | |||
| APHM - Hôpital Nord - Service de Chirurgie Digestive - Marseille - France | Laura BEYER-BERJOT | Contact (sur clinicalTrials) | |||
| APHP - HEGP- Service de Chirurgie Digestive - Paris - France | Mehdi KAROUI | Contact (sur clinicalTrials) | |||
| APHP - Hôpital Bicêtre - Service de Chirurgie Générale et Digestive - Le Kremlin-Bicêtre - France | Antoine BROUQUET | Contact (sur clinicalTrials) | |||
| APHP - Hôpital Saint-Louis - Service de Chirurgie Viscérale, Cancérologique et Endocrinienne - Paris - France | Léon MAGGIORI | Contact (sur clinicalTrials) | |||
| Centre Lyonnais de Chirurgie Digestive - Lyon - France | Benoît GIGNOUX | Contact (sur clinicalTrials) | |||
| CHRU de Besançon - Service de Chirurgie Générale, Digestive et Cancérologique - Unité de Transplantation Hépatique - Besançon - France | Zaher LAKKIS | Contact (sur clinicalTrials) | |||
| CHRU de Strasbourg - Service de Chirurgie Générale et - Strasbourg - France | Benoît ROMAIN | Contact (sur clinicalTrials) | |||
| CHRU de Tours - Service de Chirurgie Digestive Oncologique et Colorectale - Tours - France | Mehdi OUAISSI | Contact (sur clinicalTrials) | |||
| CHU Amiens-Picardie - Service de Chirurgie Digestive - Amiens - France | Jean-Marc REGIMBEAU | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux - Service de Chirurgie Digestive et Endocrinienne - Unité Colorectale - Bordeaux - France | Christophe LAURENT | Contact (sur clinicalTrials) | |||
| CHU de Clermont-Ferrand - Service de Chirurgie Digestive et Hépato-biliaire - Clermont-Ferrand - France | Anne DUBOIS | Contact (sur clinicalTrials) | |||
| CHU de Lille - Service de Chirurgie Générale et Digestive - Lille - France | Guillaume PIESSEN | Contact (sur clinicalTrials) | |||
| CHU de Rennes - Service de Chirurgie Hépatobiliaire et Digestive - Rennes - France | Véronique DESFOURNEAUX | Contact (sur clinicalTrials) | |||
| CHU de Rouen - Service de Chirugie Digestive - Rouen - France | Jean-Jacques TUECH | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - Service de Chirurgie Digestive - Toulouse - France | Laurent GHOUTI | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - Service de Chirurgie Digestive - La Tronche - France | Jean-Luc FAUCHERON | Contact (sur clinicalTrials) | |||
| Clinique Tivoli Ducos - Service de Chirurgie Digestive - Bordeaux - France | Marc-Olivier FRANCOIS | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier Paris St. Joseph - Service de Chirurgie Digestive et Obésité - Paris - France | Jérôme LORIAU | Contact (sur clinicalTrials) | |||
| Hôpital Européen de Marseille - Service de Chirurgie Digestive - Marseille - France | Antoine CAMERLO | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Sevice de Chirurgie Digestive - Pierre-Bénite - France | Eddy COTTE | Contact (sur clinicalTrials) | |||
| Institut du Cancer de Montpellier - Service de Chirurgie Digestive - Montpellier - France | Philippe ROUANET | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmette - Service de Chirurgie Digestive - Marseille - France | Cécile DE CHAISEMARTIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.