⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

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

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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

Study ID: NCT05233787

Study Description

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.

Detailed Description: The introduction of Total Mesorectal Excision (TME) as the surgical procedure of choice for low and mid rectal cancer has led to decrease local recurrence and improved oncological results. Postoperative morbidity remains a major issue, and the most feared complication is anastomotic leakage. The systematic use of a defunctioning stoma during 3 months to protect low colorectal anastomosis (below than 7 cm from the anal verge) is the standard of practice after TME surgery in order to decrease risks of anastomotic leakage and urgent re-operations. However, there have been a lot of controversies surrounding the role of defunctioning stoma mainly due to stoma-related complications, ranked from 20% to 60%, which may lead to prolonged inpatient care, urgent re-operation and devastating effects on quality of life (QOL) and healthcare expenses. Moreover, it has been reported that patients either without defunctioning stoma, or with early stoma closure (days 8-12 after TME) have a better functional outcomes than patients with systematic defunctioning stoma for 3 months. The experimental arm (arm A) will benefit from a 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). The control arm (arm B) will benefit from systematic use of defunctioning stoma for 2-3 months after TME, according to French national and international guidelines. Patients will be followed at 1, 4, 8 and 12 months after surgery, with chest, abdominal and pelvic scan and tumour markers.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Christophe LAURENT

Affiliation: University Hospital, Bordeaux

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: