Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
NCT ID: NCT05233787
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
212 participants
INTERVENTIONAL
2022-03-24
2025-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Tailored use of defunctioning stoma after TME
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.
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)
Arm B: Systematic use of defunctioning stoma
Systematic use of defunctioning stoma for 3 months after TME according to French national guidelines
Systematic use of defunctioning stoma
Systematic use of defunctioning stoma for 2-3 months after TME, according to French national and international guidelines
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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;
* Previous disease or disability expected to influence the assessment of postoperative QOL;
* Pregnancy or breast feeding;
* Persons deprived of liberty or under guardianship (curatorship or tutorship) or incapable of giving consent;
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up scheduled.
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Christophe LAURENT
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2021/10
Identifier Type: -
Identifier Source: org_study_id
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