Rectal CancerGRECCAR17NCT05233787
Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
A study testing Tailored use of defunctioning stoma after TME and Systematic use of defunctioning stoma in people with Rectal Cancer and Ileostomy; Functional Disturbance, run by University Hospital, Bordeaux at 28 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Ileostomy; Functional Disturbance
- What is being tested?
- Tailored use of defunctioning stoma after TME and Systematic use of defunctioning stoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 28 sitesFrance
- Study dates
- 24 Mar 2022to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
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- 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 locations and contacts
28 sites in 1 country.
Benjamin FERNANDEZ contact
28 sites in 1 country
France28 sites, 28 recruiting
- Recruiting
CHU Amiens-Picardie - Service de Chirurgie Digestive
Amiens
Jean-Marc REGIMBEAU, regimbeau.jean-marc@chu-amiens.fr
- Not yet recruiting
CHRU de Besançon - Service de Chirurgie Générale, Digestive et Cancérologique - Unité de Transplantation Hépatique
Besançon
Zaher LAKKIS, zlakkis@chu-besancon.fr
- Recruiting
CHU de Bordeaux - Service de Chirurgie Digestive et Endocrinienne - Unité Colorectale
Bordeaux
Christophe LAURENT, christophe.laurent@chu-bordeaux.fr
- Recruiting
Clinique Tivoli Ducos - Service de Chirurgie Digestive
Bordeaux
Marc-Olivier FRANCOIS, docteur.francois.mo@gmail.com
- Not yet recruiting
CHU de Clermont-Ferrand - Service de Chirurgie Digestive et Hépato-biliaire
Clermont-Ferrand
Anne DUBOIS, a_dubois@chu-clermontferrand.fr
- Not yet recruiting
APHP - Hôpital Beaujon - Service de Chirurgie Digestive
Clichy
Yves PANIS, yves.panis@aphp.fr
- Recruiting
CHU Grenoble Alpes - Service de Chirurgie Digestive
La Tronche
Jean-Luc FAUCHERON, JLFaucheron@chu-grenoble.fr
- Recruiting
APHP - Hôpital Bicêtre - Service de Chirurgie Générale et Digestive
Le Kremlin-Bicêtre
Antoine BROUQUET, antoine.brouquet@aphp.fr
- Recruiting
CHU de Lille - Service de Chirurgie Générale et Digestive
Lille
Guillaume PIESSEN, guillaume.piessen@chru-lille.fr
- Recruiting
Centre Lyonnais de Chirurgie Digestive
Lyon
Benoît GIGNOUX, gignoux@chirurgien-digestif.com
- Recruiting
APHM - Hôpital La Timone - Service de Chirurgie Digestive et Générale
Marseille
Diane MEGE, dr.dianemege@gmail.com
- Recruiting
APHM - Hôpital Nord - Service de Chirurgie Digestive
Marseille
Laura BEYER-BERJOT, laura.beyer@ap-hm.fr
- Recruiting
Hôpital Européen de Marseille - Service de Chirurgie Digestive
Marseille
Antoine CAMERLO, a.camerlo@hopital-europeen.fr
- Recruiting
Institut Paoli Calmette - Service de Chirurgie Digestive
Marseille
Cécile DE CHAISEMARTIN, dechaisemartinc@ipc.unicancer.fr
- Not yet recruiting
Institut du Cancer de Montpellier - Service de Chirurgie Digestive
Montpellier
Philippe ROUANET, phillipe.rouanet@montpellier.unicancer.fr
- Recruiting
APHP - HEGP- Service de Chirurgie Digestive
Paris
Mehdi KAROUI, mehdi.karoui@aphp.fr
- Recruiting
APHP - Hôpital Saint Antoine - Service de Chirurgie Digestive
Paris
Jérémie LEFEVRE, jeremie.lefevre@aphp.fr
- Not yet recruiting
APHP - Hôpital Saint-Louis - Service de Chirurgie Viscérale, Cancérologique et Endocrinienne
Paris
Léon MAGGIORI, leon.maggiori@aphp.fr
- Recruiting
GH Diaconesses Croix Saint-Simon - Service de Chirurgie Digestive
Paris
Thierry BENSIGNOR, TBensignor@hopital-dcss.org
- Not yet recruiting
Groupe Hospitalier Paris St. Joseph - Service de Chirurgie Digestive et Obésité
Paris
Jérôme LORIAU, jloriau@gmail.com
- Recruiting
Hospices Civils de Lyon - Sevice de Chirurgie Digestive
Pierre-Bénite
Eddy COTTE, eddy.cotte@chu-lyon.fr
- Not yet recruiting
CHU de Rennes - Service de Chirurgie Hépatobiliaire et Digestive
Rennes
Véronique DESFOURNEAUX, veronique.desfourneaux@chu-rennes.fr
- Recruiting
CHU de Rouen - Service de Chirugie Digestive
Rouen
Jean-Jacques TUECH, jean-jacques.tuech@chu-rouen.fr
- Recruiting
CHRU de Strasbourg - Service de Chirurgie Générale et
Strasbourg
Benoît ROMAIN, benoit.romain@chru-strasbourg.fr
- Not yet recruiting
CHU de Toulouse - Service de Chirurgie Digestive
Toulouse
Laurent GHOUTI, ghouti.l@chu-toulouse.fr
- Recruiting
CHRU de Tours - Service de Chirurgie Digestive Oncologique et Colorectale
Tours
Mehdi OUAISSI, m.ouaissi@chu-tours.fr
- Recruiting
CHRU de Nancy - Service de Chirugie Digestive, Hépatobiliaire, endocrinienne et Cancérologique
Vandœuvre-lès-Nancy
Adeline GERMAIN, a.germain@chru-nancy.fr
- Recruiting
Institut Gustave Roussy - Service de Chirurgie Viscérale Oncologique
Villejuif
Léonor BENHAIM, leonor.benhaim@gustaveroussy.fr
About this study
Official title: A Phase III Randomized Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer
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.
Read the 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.
- Conditions
- Rectal Cancer, Ileostomy; Functional Disturbance
- Being tested
- Tailored use of defunctioning stoma after TME, Systematic use of defunctioning stoma
- Keywords
- Rectal Cancer, Defunctioning stoma, Quality of life, Pelvic sepsis, Functional outcomes
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored use of defunctioning stoma after TMEProcedure or surgery
Tailored use of defunctioning stoma after TME based on a 2-step process:
- 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 stomaProcedure or surgery
Systematic use of defunctioning stoma for 2-3 months after TME, according to French national and international guidelines
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Tailored use of defunctioning stoma after TME | Experimental | 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. Receives: Procedure: Tailored use of defunctioning stoma after TME |
| Arm B: Systematic use of defunctioning stoma | Active comparator | Systematic use of defunctioning stoma for 3 months after TME according to French national guidelines Receives: Procedure: Systematic use of defunctioning stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1, 4, 8, and 12 months of follow-up
Secondary outcomes (21)
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
Measured: 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
- 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.
Measured: 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.
Measured: 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.
Measured: At 1, 4, 8, and 12 months post-surgery
Stool frequency
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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
Measured: At 1, 4, 8 and 12 months after the rectal surgery
International Index of Erectile Function (IIEF)-5
Measured in male patients
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: From baseline to Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start24 Mar 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe LAURENT, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233787
- Sponsor's protocol ID
- CHUBX 2021/10
- Acronym
- GRECCAR17
- Status last verified
- May 2024
- First submitted
- 8 Nov 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer
- ClinicalTrials.gov ID
- NCT05233787
- Acronym / sponsor ID
- GRECCAR17 / CHUBX 2021/10
- Conditions
- Rectal Cancer, Ileostomy; Functional Disturbance
- Keywords
- Rectal Cancer, Defunctioning stoma, Quality of life, Pelvic sepsis, Functional outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Tailored use of defunctioning stoma after TME | Experimental | Procedure: Tailored use of defunctioning stoma after TMEThe 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 B: Systematic use of defunctioning stoma | Active comparator | Procedure: Systematic use of defunctioning stomaSystematic use of defunctioning stoma for 3 months after TME according to French national guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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);
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored use of defunctioning stoma after TMETailored 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) | Procedure or surgery | Arm A: Tailored use of defunctioning stoma after TME |
| Systematic use of defunctioning stomaSystematic use of defunctioning stoma for 2-3 months after TME, according to French national and international guidelines | Procedure or surgery | Arm B: Systematic use of defunctioning stoma |
Primary outcome
Quality of life over the 12 months after surgery
Time frame: At 1, 4, 8, and 12 months of follow-up
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.
21 secondary outcomes
Proportion of anastomotic leakage
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
Time frame: At 1, 4, 8 and 12 months after the rectal surgery
The urinary frequency
Time frame: At 1, 4, 8, and 12 months post-surgery
Blood or mucus in stools
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
Time frame: At 1, 4, 8, and 12 months post-surgery
Rate of defunctioning stoma
Time frame: At 1 month after the rectal surgery
Low Anterior Resection Syndrome score (LARS score)
Time frame: At 1, 4, 8 and 12 months after the rectal surgery
Anal Incontinence (Wexner score)
Time frame: At 1, 4, 8 and 12 months after the rectal surgery
International Index of Erectile Function (IIEF)-5
Time frame: At 1, 4, 8 and 12 months after the rectal surgery
Female Sexual Function Index (FSFI) scale scores
Time frame: At 1, 4, 8 and 12 months after the rectal surgery
Urinary symptom profil (USP)
Time frame: At 1, 4, 8, 12 months after the rectal surgery
Postoperative morbidity (Clavien-Dindo score I-IV)
Time frame: At 1 and 4 months after the rectal surgery
Postoperative mortality (Clavien-Dindo score V)
Time frame: At 1 and 4 months after the rectal surgery
Proportion to work return after TME in active workers
Time frame: Through study completion, an average of 1 year
Time to work return after TME in active workers
Time frame: Through study completion, an average of 1 year
Quality of life over the 12 months after surgery
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
Time frame: From surgery to 12 months after surgery
Total budgetary impact for French healthcare insurance system of spreading selective ostomy practice in France
Time frame: From surgery to 12 months after surgery
Indirect Costs (€) for French Healthcare insurance scheme of sickness leaves
Time frame: From surgery to 12 months after surgery
Changes in microbiome composition and diversity from baseline to 1 month
Time frame: From baseline to Month 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin FERNANDEZ contact
Christophe LAURENT principal investigator
University Hospital, Bordeaux
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored use of defunctioning stoma after TME and Systematic use of defunctioning stoma in people with Rectal Cancer and Ileostomy; Functional Disturbance, run by University Hospital, Bordeaux at 28 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe LAURENT ((0)5 57 65 67 69 ext. +33, christophe.laurent@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life over the 12 months after surgery (time frame: At 1, 4, 8, and 12 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.