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RecruitingNot ApplicableNCT05233787

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

Sponsor

University Hospital, Bordeaux

Enrollment

212 participants

Start Date

Mar 24, 2022

Study Type

INTERVENTIONAL

Conditions

Rectal CancerIleostomy; Functional Disturbance

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial (GRECCAR17) is comparing two surgical approaches for patients with rectal cancer: routinely creating a temporary stoma (a small opening in the abdomen to divert stool) versus only doing so when certain high-risk features are present. The goal is to reduce unnecessary stomas while keeping patients safe. **You may be eligible if...** - You are between 18 and 80 years old - You have confirmed rectal adenocarcinoma located within 12 cm of the anal opening - Your cancer has not spread to distant organs (no metastasis) - You are scheduled for minimally invasive rectal surgery (laparoscopic, robotic, or TaTME) with or without prior chemotherapy or radiation - You have had a stapled bowel reconnection (anastomosis) **You may NOT be eligible if...** - You have metastatic disease - You are outside the 18–80 age range - You have an emergency presentation (obstruction or perforation requiring immediate surgery) - You have had prior rectal surgery that affects the planned procedure Talk to your doctor to see if this trial is right for you.

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Interventions

PROCEDURETailored 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)

PROCEDURESystematic 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

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NCT05233787

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