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Studies

Interventional Recruiting

NCT05233787 on ClinicalTrials.gov

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

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

  • Sponsor: Hôpital Saint-André
  • Enrollment: 212 (Estimated)
  • Study start: 2022-03-24 (Actual)
  • Primary completion: 2025-09-01 (Estimated)
  • Study completion: 2025-09-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Rectal Cancer
  • Ileostomy; Functional Disturbance

Intervention / Treatment

  • Procedure: Tailored use of defunctioning stoma after TME
  • Procedure: Systematic use of defunctioning stoma

Primary Outcome Measures

  • Quality of life over the 12 months after surgery (At 1, 4, 8, and 12 months of follow-up)
    The QLQ-C30 is a patient self-rating questionnaire (30 questions) that measures physical, role, social, emotional, and cognitive functions as well as overall QoL. Scores can be linearly transformed to provide a score from 0 to 100 REF. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales. The area under the quality of life curve will be measured over the 12 months after rectal surgery, with measurement time points at 1, 4, 8 and 12 months.

Countries

France

Locations and Investigators

  • CHU Amiens-Picardie - Service de Chirurgie Digestive, Amiens, France (Recruiting)
  • CHRU de Besançon - Service de Chirurgie Générale, Digestive et Cancérologique - Unité de Transplantation Hépatique, Besançon, France (Not yet recruiting)
  • CHU de Bordeaux - Service de Chirurgie Digestive et Endocrinienne - Unité Colorectale, Bordeaux, France (Recruiting)
  • Clinique Tivoli Ducos - Service de Chirurgie Digestive, Bordeaux, France (Recruiting)
    • Marc-Olivier FRANCOIS
  • CHU de Clermont-Ferrand - Service de Chirurgie Digestive et Hépato-biliaire, Clermont-Ferrand, France (Not yet recruiting)
    • Anne DUBOIS
  • APHP - Hôpital Beaujon - Service de Chirurgie Digestive, Clichy, France (Not yet recruiting)
  • CHU Grenoble Alpes - Service de Chirurgie Digestive, La Tronche, France (Recruiting)
  • APHP - Hôpital Bicêtre - Service de Chirurgie Générale et Digestive, Le Kremlin-Bicêtre, France (Recruiting)
    • Antoine BROUQUET
  • CHU de Lille - Service de Chirurgie Générale et Digestive, Lille, France (Recruiting)
  • Centre Lyonnais de Chirurgie Digestive, Lyon, France (Recruiting)
    • Benoît GIGNOUX
  • APHM - Hôpital La Timone - Service de Chirurgie Digestive et Générale, Marseille, France (Recruiting)
  • APHM - Hôpital Nord - Service de Chirurgie Digestive, Marseille, France (Recruiting)
    • Laura BEYER-BERJOT
  • Hôpital Européen de Marseille - Service de Chirurgie Digestive, Marseille, France (Recruiting)
    • Antoine CAMERLO
  • Institut Paoli Calmette - Service de Chirurgie Digestive, Marseille, France (Recruiting)
    • Cécile DE CHAISEMARTIN
  • Institut du Cancer de Montpellier - Service de Chirurgie Digestive, Montpellier, France (Not yet recruiting)
  • APHP - HEGP- Service de Chirurgie Digestive, Paris, France (Recruiting)
  • APHP - Hôpital Saint Antoine - Service de Chirurgie Digestive, Paris, France (Recruiting)
  • APHP - Hôpital Saint-Louis - Service de Chirurgie Viscérale, Cancérologique et Endocrinienne, Paris, France (Not yet recruiting)
  • GH Diaconesses Croix Saint-Simon - Service de Chirurgie Digestive, Paris, France (Recruiting)
    • Thierry BENSIGNOR
  • Groupe Hospitalier Paris St. Joseph - Service de Chirurgie Digestive et Obésité, Paris, France (Not yet recruiting)
    • Jérôme LORIAU
  • Hospices Civils de Lyon - Sevice de Chirurgie Digestive, Pierre-Bénite, France (Recruiting)
  • CHU de Rennes - Service de Chirurgie Hépatobiliaire et Digestive, Rennes, France (Not yet recruiting)
    • Véronique DESFOURNEAUX
  • CHU de Rouen - Service de Chirugie Digestive, Rouen, France (Recruiting)
  • CHRU de Strasbourg - Service de Chirurgie Générale et, Strasbourg, France (Recruiting)
    • Benoît ROMAIN
  • CHU de Toulouse - Service de Chirurgie Digestive, Toulouse, France (Not yet recruiting)
    • Laurent GHOUTI
  • CHRU de Tours - Service de Chirurgie Digestive Oncologique et Colorectale, Tours, France (Recruiting)
  • CHRU de Nancy - Service de Chirugie Digestive, Hépatobiliaire, endocrinienne et Cancérologique, VandÅ“uvre-lès-Nancy, France (Recruiting)
    • Adeline GERMAIN
  • Institut Gustave Roussy - Service de Chirurgie Viscérale Oncologique, Villejuif, France (Recruiting)
    • Léonor BENHAIM

Study Officials