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Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
Sponsor: University Hospital, Bordeaux
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.
Official title: A Phase III Randomized Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
212
Start Date
2022-03-24
Completion Date
2025-09
Last Updated
2024-05-16
Healthy Volunteers
No
Interventions
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)
Systematic use of defunctioning stoma
Systematic use of defunctioning stoma for 2-3 months after TME, according to French national and international guidelines
Locations (28)
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
Hospices Civils de Lyon - Sevice de Chirurgie Digestive
Pierre-Bénite, France
CHU de Rennes - Service de Chirurgie Hépatobiliaire et Digestive
Rennes, France
CHU de Rouen - Service de Chirugie Digestive
Rouen, France
CHRU de Strasbourg - Service de Chirurgie Générale et
Strasbourg, France
CHU de Toulouse - Service de Chirurgie Digestive
Toulouse, France
CHRU de Tours - Service de Chirurgie Digestive Oncologique et Colorectale
Tours, France
CHRU de Nancy - Service de Chirugie Digestive, Hépatobiliaire, endocrinienne et Cancérologique
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy - Service de Chirurgie Viscérale Oncologique
Villejuif, France