Actively Recruiting
Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
Led by University Hospital, Bordeaux · Updated on 2024-05-16
212
Participants Needed
28
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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;
- 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.
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Trial Site Locations
Total: 28 locations
1
CHU Amiens-Picardie - Service de Chirurgie Digestive
Amiens, France
Actively Recruiting
2
CHRU de Besançon - Service de Chirurgie Générale, Digestive et Cancérologique - Unité de Transplantation Hépatique
Besançon, France
Not Yet Recruiting
3
CHU de Bordeaux - Service de Chirurgie Digestive et Endocrinienne - Unité Colorectale
Bordeaux, France
Actively Recruiting
4
Clinique Tivoli Ducos - Service de Chirurgie Digestive
Bordeaux, France
Actively Recruiting
5
CHU de Clermont-Ferrand - Service de Chirurgie Digestive et Hépato-biliaire
Clermont-Ferrand, France
Not Yet Recruiting
6
APHP - Hôpital Beaujon - Service de Chirurgie Digestive
Clichy, France
Not Yet Recruiting
7
CHU Grenoble Alpes - Service de Chirurgie Digestive
La Tronche, France
Actively Recruiting
8
APHP - Hôpital Bicêtre - Service de Chirurgie Générale et Digestive
Le Kremlin-Bicêtre, France
Actively Recruiting
9
CHU de Lille - Service de Chirurgie Générale et Digestive
Lille, France
Actively Recruiting
10
Centre Lyonnais de Chirurgie Digestive
Lyon, France
Actively Recruiting
11
APHM - Hôpital La Timone - Service de Chirurgie Digestive et Générale
Marseille, France
Actively Recruiting
12
APHM - Hôpital Nord - Service de Chirurgie Digestive
Marseille, France
Actively Recruiting
13
Hôpital Européen de Marseille - Service de Chirurgie Digestive
Marseille, France
Actively Recruiting
14
Institut Paoli Calmette - Service de Chirurgie Digestive
Marseille, France
Actively Recruiting
15
Institut du Cancer de Montpellier - Service de Chirurgie Digestive
Montpellier, France
Not Yet Recruiting
16
APHP - HEGP- Service de Chirurgie Digestive
Paris, France
Actively Recruiting
17
APHP - Hôpital Saint Antoine - Service de Chirurgie Digestive
Paris, France
Actively Recruiting
18
APHP - Hôpital Saint-Louis - Service de Chirurgie Viscérale, Cancérologique et Endocrinienne
Paris, France
Not Yet Recruiting
19
GH Diaconesses Croix Saint-Simon - Service de Chirurgie Digestive
Paris, France
Actively Recruiting
20
Groupe Hospitalier Paris St. Joseph - Service de Chirurgie Digestive et Obésité
Paris, France
Not Yet Recruiting
21
Hospices Civils de Lyon - Sevice de Chirurgie Digestive
Pierre-Bénite, France
Actively Recruiting
22
CHU de Rennes - Service de Chirurgie Hépatobiliaire et Digestive
Rennes, France
Not Yet Recruiting
23
CHU de Rouen - Service de Chirugie Digestive
Rouen, France
Actively Recruiting
24
CHRU de Strasbourg - Service de Chirurgie Générale et
Strasbourg, France
Actively Recruiting
25
CHU de Toulouse - Service de Chirurgie Digestive
Toulouse, France
Not Yet Recruiting
26
CHRU de Tours - Service de Chirurgie Digestive Oncologique et Colorectale
Tours, France
Actively Recruiting
27
CHRU de Nancy - Service de Chirugie Digestive, Hépatobiliaire, endocrinienne et Cancérologique
Vandœuvre-lès-Nancy, France
Actively Recruiting
28
Institut Gustave Roussy - Service de Chirurgie Viscérale Oncologique
Villejuif, France
Actively Recruiting
Research Team
C
Christophe LAURENT
CONTACT
B
Benjamin FERNANDEZ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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