Back to resultsTrial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17) (GRECCAR17)
Primary Purpose
Rectal Cancer, Ileostomy; Functional Disturbance
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tailored use of defunctioning stoma after TME
Systematic use of defunctioning stoma
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Defunctioning stoma, Quality of life, Pelvic sepsis, Functional outcomes
Eligibility Criteria
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);
- Appropriate hepatic function: ASAT/ALAT < 100 IU/L;
- 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.
Sites / Locations
- CHU Amiens-Picardie - Service de Chirurgie DigestiveRecruiting
- CHRU de Besançon - Service de Chirurgie Générale, Digestive et Cancérologique - Unité de Transplantation Hépatique
- CHU de Bordeaux - Service de Chirurgie Digestive et Endocrinienne - Unité ColorectaleRecruiting
- Clinique Tivoli Ducos - Service de Chirurgie DigestiveRecruiting
- CHU de Clermont-Ferrand - Service de Chirurgie Digestive et Hépato-biliaire
- APHP - Hôpital Beaujon - Service de Chirurgie Digestive
- CHU Grenoble Alpes - Service de Chirurgie DigestiveRecruiting
- APHP - Hôpital Bicêtre - Service de Chirurgie Générale et DigestiveRecruiting
- Centre Oscar Lambret - Service de Chirurgie Digestive
- CHU de Lille - Service de Chirurgie Générale et DigestiveRecruiting
- Centre Lyonnais de Chirurgie Digestive
- APHM - Hôpital La Timone - Service de Chirurgie Digestive et GénéraleRecruiting
- APHM - Hôpital Nord - Service de Chirurgie DigestiveRecruiting
- Hôpital Européen de Marseille - Service de Chirurgie DigestiveRecruiting
- Institut Paoli Calmette - Service de Chirurgie DigestiveRecruiting
- Institut du Cancer de Montpellier - Service de Chirurgie Digestive
- APHP - HEGP- Service de Chirurgie DigestiveRecruiting
- APHP - Hôpital Saint Antoine - Service de Chirurgie DigestiveRecruiting
- APHP - Hôpital Saint-Louis - Service de Chirurgie Viscérale, Cancérologique et Endocrinienne
- GH Diaconesses Croix Saint-Simon - Service de Chirurgie Digestive
- Groupe Hospitalier Paris St. Joseph - Service de Chirurgie Digestive et Obésité
- Hospices Civils de Lyon - Sevice de Chirurgie DigestiveRecruiting
- CHU de Rennes - Service de Chirurgie Hépatobiliaire et Digestive
- CHU de Rouen - Service de Chirugie DigestiveRecruiting
- CHRU de Strasbourg - Service de Chirurgie Générale etRecruiting
- CHU de Toulouse - Service de Chirurgie Digestive
- CHRU de Tours - Service de Chirurgie Digestive Oncologique et Colorectale
- CHRU de Nancy - Service de Chirugie Digestive, Hépatobiliaire, endocrinienne et CancérologiqueRecruiting
- Institut Gustave Roussy - Service de Chirurgie Viscérale OncologiqueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A: Tailored use of defunctioning stoma after TME
Arm B: Systematic use of defunctioning stoma
Arm 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.
Systematic use of defunctioning stoma for 3 months after TME according to French national guidelines
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
The PF, RF, CF, EF, SF, FA, PA, NV, QL Dimensions of the QLQ-C30 questionnaire
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.
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.
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.
Stool frequency
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.
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)
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).
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
International Index of Erectile Function (IIEF)-5
Measured in male patients
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.
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.
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.
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.
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 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.
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.
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.
Total budgetary impact for French healthcare insurance system of spreading selective ostomy practice in France
5-year financial model
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
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.
Full Information
NCT ID
NCT05233787
First Posted
November 8, 2021
Last Updated
August 16, 2023
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT05233787
Brief Title
Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
Acronym
GRECCAR17
Official Title
A Phase III Randomized Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Ileostomy; Functional Disturbance
Keywords
Rectal Cancer, Defunctioning stoma, Quality of life, Pelvic sepsis, Functional outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Tailored use of defunctioning stoma after TME
Arm Type
Experimental
Arm 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.
Arm Title
Arm B: Systematic use of defunctioning stoma
Arm Type
Active Comparator
Arm Description
Systematic use of defunctioning stoma for 3 months after TME according to French national guidelines
Intervention Type
Procedure
Intervention Name(s)
Tailored use of defunctioning stoma after TME
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Systematic use of defunctioning stoma
Intervention Description
Systematic use of defunctioning stoma for 2-3 months after TME, according to French national and international guidelines
Primary Outcome Measure Information:
Title
Quality of life over the 12 months after surgery
Description
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
Secondary Outcome Measure Information:
Title
Proportion of anastomotic leakage
Description
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
Title
The PF, RF, CF, EF, SF, FA, PA, NV, QL Dimensions of the QLQ-C30 questionnaire
Description
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
Title
The urinary frequency
Description
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
Title
Blood or mucus in stools
Description
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
Title
Stool frequency
Time Frame
At 1, 4, 8, and 12 months post-surgery
Title
Body image dimensions of the QLQ-CR29 questionnaire
Description
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
Title
Rate of defunctioning stoma
Description
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
Title
Low Anterior Resection Syndrome score (LARS score)
Description
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
Title
Anal Incontinence (Wexner score)
Description
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
Title
International Index of Erectile Function (IIEF)-5
Description
Measured in male patients
Time Frame
At 1, 4, 8 and 12 months after the rectal surgery
Title
Female Sexual Function Index (FSFI) scale scores
Description
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
Title
Urinary symptom profil (USP)
Description
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
Title
Postoperative morbidity (Clavien-Dindo score I-IV)
Description
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
Title
Postoperative mortality (Clavien-Dindo score V)
Description
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
Title
Proportion to work return after TME in active workers
Description
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
Title
Time to work return after TME in active workers
Description
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
Title
Quality of life over the 12 months after surgery
Description
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
Title
Incremental cost-utility ratio defined as an incremental cost / Quality-Adjsuted Life Year (QALY) gained
Description
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
Title
Total budgetary impact for French healthcare insurance system of spreading selective ostomy practice in France
Description
5-year financial model
Time Frame
From surgery to 12 months after surgery
Title
Indirect Costs (€) for French Healthcare insurance scheme of sickness leaves
Description
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
Title
Changes in microbiome composition and diversity from baseline to 1 month
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe LAURENT
Phone
(0)5 57 65 67 69
Ext
+33
Email
christophe.laurent@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Eric RULLIER
Email
eric.rullier@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe LAURENT
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Picardie - Service de Chirurgie Digestive
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc REGIMBEAU
Email
regimbeau.jean-marc@chu-amiens.fr
Facility Name
CHRU de Besançon - Service de Chirurgie Générale, Digestive et Cancérologique - Unité de Transplantation Hépatique
City
Besançon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaher LAKKIS
Email
zlakkis@chu-besancon.fr
Facility Name
CHU de Bordeaux - Service de Chirurgie Digestive et Endocrinienne - Unité Colorectale
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe LAURENT
Email
christophe.laurent@chu-bordeaux.fr
Facility Name
Clinique Tivoli Ducos - Service de Chirurgie Digestive
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc-Olivier FRANCOIS
Email
docteur.francois.mo@gmail.com
Facility Name
CHU de Clermont-Ferrand - Service de Chirurgie Digestive et Hépato-biliaire
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DUBOIS
Email
a_dubois@chu-clermontferrand.fr
Facility Name
APHP - Hôpital Beaujon - Service de Chirurgie Digestive
City
Clichy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves PANIS
Email
yves.panis@aphp.fr
Facility Name
CHU Grenoble Alpes - Service de Chirurgie Digestive
City
La Tronche
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc FAUCHERON
Email
JLFaucheron@chu-grenoble.fr
Facility Name
APHP - Hôpital Bicêtre - Service de Chirurgie Générale et Digestive
City
Le Kremlin-Bicêtre
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine BROUQUET
Email
antoine.brouquet@aphp.fr
Facility Name
Centre Oscar Lambret - Service de Chirurgie Digestive
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehrdad JAFARI
Email
m-jafari@o-lambret.fr
Facility Name
CHU de Lille - Service de Chirurgie Générale et Digestive
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume PIESSEN
Email
guillaume.piessen@chru-lille.fr
Facility Name
Centre Lyonnais de Chirurgie Digestive
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoît GIGNOUX
Email
gignoux@chirurgien-digestif.com
Facility Name
APHM - Hôpital La Timone - Service de Chirurgie Digestive et Générale
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane MEGE
Email
dr.dianemege@gmail.com
Facility Name
APHM - Hôpital Nord - Service de Chirurgie Digestive
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura BEYER-BERJOT
Email
laura.beyer@ap-hm.fr
Facility Name
Hôpital Européen de Marseille - Service de Chirurgie Digestive
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine CAMERLO
Email
a.camerlo@hopital-europeen.fr
Facility Name
Institut Paoli Calmette - Service de Chirurgie Digestive
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile DE CHAISEMARTIN
Email
dechaisemartinc@ipc.unicancer.fr
Facility Name
Institut du Cancer de Montpellier - Service de Chirurgie Digestive
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe ROUANET
Email
phillipe.rouanet@montpellier.unicancer.fr
Facility Name
APHP - HEGP- Service de Chirurgie Digestive
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehdi KAROUI
Email
mehdi.karoui@aphp.fr
Facility Name
APHP - Hôpital Saint Antoine - Service de Chirurgie Digestive
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémie LEFEVRE
Email
jeremie.lefevre@aphp.fr
Facility Name
APHP - Hôpital Saint-Louis - Service de Chirurgie Viscérale, Cancérologique et Endocrinienne
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Léon MAGGIORI
Email
leon.maggiori@aphp.fr
Facility Name
GH Diaconesses Croix Saint-Simon - Service de Chirurgie Digestive
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry BENSIGNOR
Email
TBensignor@hopital-dcss.org
Facility Name
Groupe Hospitalier Paris St. Joseph - Service de Chirurgie Digestive et Obésité
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme LORIAU
Email
jloriau@gmail.com
Facility Name
Hospices Civils de Lyon - Sevice de Chirurgie Digestive
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddy COTTE
Email
eddy.cotte@chu-lyon.fr
Facility Name
CHU de Rennes - Service de Chirurgie Hépatobiliaire et Digestive
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique DESFOURNEAUX
Email
veronique.desfourneaux@chu-rennes.fr
Facility Name
CHU de Rouen - Service de Chirugie Digestive
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques TUECH
Email
jean-jacques.tuech@chu-rouen.fr
Facility Name
CHRU de Strasbourg - Service de Chirurgie Générale et
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoît ROMAIN
Email
benoit.romain@chru-strasbourg.fr
Facility Name
CHU de Toulouse - Service de Chirurgie Digestive
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent GHOUTI
Email
ghouti.l@chu-toulouse.fr
Facility Name
CHRU de Tours - Service de Chirurgie Digestive Oncologique et Colorectale
City
Tours
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehdi OUAISSI
Email
m.ouaissi@chu-tours.fr
Facility Name
CHRU de Nancy - Service de Chirugie Digestive, Hépatobiliaire, endocrinienne et Cancérologique
City
Vandœuvre-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeline GERMAIN
Email
a.germain@chru-nancy.fr
Facility Name
Institut Gustave Roussy - Service de Chirurgie Viscérale Oncologique
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Léonor BENHAIM
Email
leonor.benhaim@gustaveroussy.fr
12. IPD Sharing Statement
Learn more about this trial
Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
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