NCT05233787

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

28 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 24, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

3.4 years

First QC Date

November 8, 2021

Last Update Submit

May 14, 2024

Conditions

Rectal CancerIleostomy; Functional Disturbance

Keywords

Rectal CancerDefunctioning stomaQuality of lifePelvic sepsisFunctional outcomes

Outcome Measures

Primary Outcomes (1)

  • Quality of life over the 12 months after surgery

    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.

    At 1, 4, 8, and 12 months of follow-up

Secondary Outcomes (21)

  • Proportion of anastomotic leakage

    At 1 and 4 months after the rectal surgery

  • The PF, RF, CF, EF, SF, FA, PA, NV, QL Dimensions of the QLQ-C30 questionnaire

    At 1, 4, 8 and 12 months after the rectal surgery

  • The urinary frequency

    At 1, 4, 8, and 12 months post-surgery

  • Blood or mucus in stools

    At 1, 4, 8, and 12 months post-surgery

  • Stool frequency

    At 1, 4, 8, and 12 months post-surgery

  • +16 more secondary outcomes

Study Arms (2)

Arm A: Tailored use of defunctioning stoma after TME

EXPERIMENTAL

The tailored use of defunctioning stoma includes two steps: * Firstly, the decision to use or not a defunctioning stoma will be based on the personalized risk of anastomotic leakage (according to AFOR score). This score is ranked from 0 to 6, and includes gender, Body Mass Index, smoking, diabetes, tumor size and preoperative radiotherapy. * Patients with AFORS equal to 0 or 1 (risk of anastomotic leakage less than 10%) will not have defunctioning stoma; * Patients with AFORS equal to or between 2 and 6 (risk of anastomotic leakage more than 20%) will have a defunctioning stoma. * Secondly, in patients with a defunctioning stoma, an early closure will be performed day 8-12 after TME if: * No fever postoperatively (≤ 38°C), * CRP at day 2 lower than 115mg/L (+/- 10 mg/L), decreasing at day 4, * CT-scan with colonic contrast retrograde enema showing no anastomotic leakage.

Procedure: Tailored use of defunctioning stoma after TME

Arm B: Systematic use of defunctioning stoma

ACTIVE COMPARATOR

Systematic use of defunctioning stoma for 3 months after TME according to French national guidelines

Procedure: Systematic use of defunctioning stoma

Interventions

Tailored use of defunctioning stoma after TMEPROCEDURE

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)

Arm A: Tailored use of defunctioning stoma after TME
Systematic use of defunctioning stomaPROCEDURE

Systematic use of defunctioning stoma for 2-3 months after TME, according to French national and international guidelines

Arm B: Systematic use of defunctioning stoma

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

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

CHU de Clermont-Ferrand - Service de Chirurgie Digestive et Hépato-biliaire

Clermont-Ferrand, France

NOT YET RECRUITING

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

CHU de Lille - Service de Chirurgie Générale et Digestive

Lille, France

RECRUITING

Centre Lyonnais de Chirurgie Digestive

Lyon, France

RECRUITING

APHM - Hôpital La Timone - Service de Chirurgie Digestive et Générale

Marseille, France

RECRUITING

APHM - Hôpital Nord - Service de Chirurgie Digestive

Marseille, France

RECRUITING

Hôpital Européen de Marseille - Service de Chirurgie Digestive

Marseille, France

RECRUITING

Institut Paoli Calmette - Service de Chirurgie Digestive

Marseille, France

RECRUITING

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

Groupe Hospitalier Paris St. Joseph - Service de Chirurgie Digestive et Obésité

Paris, France

NOT YET RECRUITING

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

CHU de Rouen - Service de Chirugie Digestive

Rouen, France

RECRUITING

CHRU de Strasbourg - Service de Chirurgie Générale et

Strasbourg, France

RECRUITING

CHU de Toulouse - Service de Chirurgie Digestive

Toulouse, France

NOT YET RECRUITING

CHRU de Tours - Service de Chirurgie Digestive Oncologique et Colorectale

Tours, France

RECRUITING

CHRU de Nancy - Service de Chirugie Digestive, Hépatobiliaire, endocrinienne et Cancérologique

Vandœuvre-lès-Nancy, France

RECRUITING

Institut Gustave Roussy - Service de Chirurgie Viscérale Oncologique

Villejuif, France

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Christophe LAURENT

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe LAURENT

CONTACT

(0)5 57 65 67 69christophe.laurent@chu-bordeaux.fr

Benjamin FERNANDEZ

CONTACT

benjamin.fernandez@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

February 10, 2022

Study Start

March 24, 2022

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

FR(28)