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

University Hospital of Bordeaux

Status: Enrolling

Conditions: Ileostomy; Functional Disturbance; Rectal Cancer

Treatments: Procedure: Tailored use of defunctioning stoma after TME; Procedure: Systematic use of defunctioning stoma

Study type: Interventional

Funder types: Other

Identifiers

NCT05233787

CHUBX 2021/10

Details and patient eligibility

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.

Full 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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

Arm A: Tailored use of defunctioning stoma after TME

Experimental group

Description:

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.

Treatment:

Procedure: Tailored use of defunctioning stoma after TME

Arm B: Systematic use of defunctioning stoma

Active Comparator group

Description:

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

Treatment:

Procedure: Systematic use of defunctioning stoma