An interventional study of Tailored use of defunctioning stoma after TME and Systematic use of defunctioning stoma in Rectal Cancer and Ileostomy; Functional Disturbance, sponsored by University Hospital, Bordeaux. Recruiting at 28 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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
Systematic use of defunctioning stoma for 3 months after TME according to French national guidelines
Procedure: Systematic use of defunctioning stoma
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 for 2-3 months after TME, according to French national and international guidelines
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.
Time frame: At 1, 4, 8, and 12 months of follow-up
Proportion of anastomotic leakage
Proportion of patients with an anastomotic leakage will be assessed by a clinical exam (with a rectal examination) at 1 month and with a clinical exam (with a rectal examination) and a CT scan at 4 months after rectal surgery
Time frame: 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
1. 9 dimensions will be assessed with: * PF : Physical Functioning * RF : Role Functioning * CF : Cognitive Functioning * EF : Emotional Functioning * SF: Social Functioning * FA : Fatigue * PA : Pain * NV : Nausea and Vomiting * QL : Global health status 2- The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. This is a patients self-rating questionnaire that measures five functional scales (physical, role, social, emotional, and cognitive) three symptom scales (fatigue, pain, nausea and vomiting) A global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. 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.
Time frame: At 1, 4, 8 and 12 months after the rectal surgery
The urinary frequency
The QLQ-CR29 (Quality of life of rectal cancer patients with 29 questions) has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items. Urinary frequency is measured with items 1 and 2 of the questionnaire. The score can range from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.
Time frame: At 1, 4, 8, and 12 months post-surgery
Blood or mucus in stools
The QLQ-CR29 (Quality of life of rectal cancer patients with 29 questions) has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items. The blood or mucus in stools is measured with items 8 and 9 of the questionnaire. The score can range from 0 to 50. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.
Time frame: At 1, 4, 8, and 12 months post-surgery
Stool frequency
Time frame: At 1, 4, 8, and 12 months post-surgery
Body image dimensions of the QLQ-CR29 questionnaire
The QLQ-CR29 (Quality of life of rectal cancer patients with 29 questions) has five functional and 18 symptom scales. Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.
Time frame: At 1, 4, 8, and 12 months post-surgery
Rate of defunctioning stoma
Proportion of patients who have a defunctioning stoma. It will be assessed at the time of the consultation at 1 month with the collection of the adverse events (AE) and the serious adverse events (SAE)
Time frame: At 1 month after the rectal surgery
Low Anterior Resection Syndrome score (LARS score)
The LARS questionnaire (low anterior resection score) evaluates bowel function. Five questions regarding incontinence for flatus and liquid stools, frequency, clustering and urgency for defecation are taken into account. The score ranges from 0 to 42 is divides into no LARS (0 to 20 points), minor LARS (21 to 29 points), and major LARS (30 to 42 points).
Time frame: At 1, 4, 8 and 12 months after the rectal surgery
Anal Incontinence (Wexner score)
The WEXNER score assesses the importance of anal incontinence, it varies from 0 to 20, 20 corresponding to total anal incontinence
Time frame: At 1, 4, 8 and 12 months after the rectal surgery
International Index of Erectile Function (IIEF)-5
Measured in male patients
Time frame: At 1, 4, 8 and 12 months after the rectal surgery
Female Sexual Function Index (FSFI) scale scores
Measured in female patients. The Female Sexual Function Index (FSFI) is a 19-item self-report inventory designed to assess female sexual function. It comprises six domains: desire, arousal ,lubrication orgasm, satisfaction, pain. The maximum score for each domain is 6.0, obtained by summing item responses and multiplying by a correction factor. The total composite sexual function score is a sum of domain scores and ranges from 2.0 (not sexually active and no desire) to 36.0.
Time frame: At 1, 4, 8 and 12 months after the rectal surgery
Urinary symptom profil (USP)
The Urinary symptom profil (USP) assesses urinary symptoms among men and women with stress, urge (from 0 to 9), overactive bladder (from 0 to 9), or urinary obstructive symptoms (from 0 to 9). The maximum corresponding to a bad result.
Time frame: At 1, 4, 8, 12 months after the rectal surgery
Postoperative morbidity (Clavien-Dindo score I-IV)
This is a classification in order to rank a complication (surgical or medical morbidity) in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. It varies from 1 to 5, 5 corresponding to the death at the patient.
Time frame: At 1 and 4 months after the rectal surgery
Postoperative mortality (Clavien-Dindo score V)
This is a classification in order to rank a complication (surgical or medical morbidity) in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. It varies from 1 to 5, 5 corresponding to the death at the patient.
Time frame: At 1 and 4 months after the rectal surgery
Proportion to work return after TME in active workers
This endpoint is referring to the capability of active patients to resume their professional activity after surgery. In order to better describe this endpoint the investigators want to measure together the proportion of patients resuming their activity, and the time until resumption of professional activity.
Time frame: Through study completion, an average of 1 year
Time to work return after TME in active workers
This endpoint is referring to the capability of active patients to resume their professional activity after surgery. In order to better describe this endpoint the investigators want to measure together the proportion of patients resuming their activity, and the time until resumption of professional activity.
Time frame: Through study completion, an average of 1 year
Quality of life over the 12 months after surgery
The Quality of life of cancer contains 30 questions (QLQ-C30). This is a patients self-rating questionnaire 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.Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.
Time frame: QLQ-C30 is assessed at 1, 4, 8 and 12 months after the rectal surgery
Incremental cost-utility ratio defined as an incremental cost / Quality-Adjsuted Life Year (QALY) gained
Costs will be measured through the French Health Data Hub database. QALYs will be measured using the and EQ-5D-5L questionnaire.
Time frame: From surgery to 12 months after surgery
Total budgetary impact for French healthcare insurance system of spreading selective ostomy practice in France
5-year financial model
Time frame: From surgery to 12 months after surgery
Indirect Costs (€) for French Healthcare insurance scheme of sickness leaves
Measured through SNDS database (Système National des Données de Santé) and data from our study on sickness leaves and times to return to work
Time frame: From surgery to 12 months after surgery
Changes in microbiome composition and diversity from baseline to 1 month
Data will be rarefied using the samples with the smallest number of reads and then subjected to alpha-diversity analysis employing Faith's phylogenetic diversity. Kruskal-Wallis will be calculated between all groups together and for pairwise comparisons. To find significant differences at the genera taxonomy level, ANCOM tests will be used to identify features that are differentially abundant across sample groups.
Time frame: From baseline to Month 1
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University Hospital, Bordeaux