A phase III randomized trial evaluating the quality of life impact of a tailored versus systematic use of defunctioning ileostomy following total mesorectal excision for rectal cancer - GRECCAR 17 trial protocol
| dc.rights.license | open | en_US |
| dc.contributor.author | DENOST, Quentin | |
| dc.contributor.author | SYLLA, Dienabou | |
| dc.contributor.author | FLEMING, Christina | |
| dc.contributor.author | MAILLOU-MARTINAUD, Helene | |
| dc.contributor.author | PREAUBERT-HAYES, Nathalie | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | BENARD, Antoine | |
| dc.date.accessioned | 2022-12-15T10:21:05Z | |
| dc.date.available | 2022-12-15T10:21:05Z | |
| dc.date.issued | 2023-03 | |
| dc.identifier.issn | 1463-1318 (Electronic) 1462-8910 (Linking) | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/171533 | |
| dc.description.abstractEn | AIM: The systematic use of a defunctioning ileostomy for 2-3 months post-operatively to protect low colorectal anastomosis (<7 cm from the anal verge) has been the standard practice after total mesorectal excision (TME). However, stoma-related complications can occur in 20%-60% of cases, which may lead to prolonged inpatient care, urgent re-operation, long term definitive stoma. A negative impact on quality of life (QOL) and increased healthcare expenses are also observed. Conversely, it has been reported that patients without defunctioning stoma or following early stoma closure (days 8-12 after TME) have a better functional outcome than patients with systematic defunctioning stoma in situ for 2-3 months. METHOD: The main objective of this trial is to compare the QoL impact of a tailored versus systematic use of defunctioning stoma after TME for rectal cancer. The primary outcome is QoL at 12 months post-operatively using the EORTC QLQ-C30. Among 29 centres of the French GRECCAR network, 200 patients will be recruited over 18 months, with follow-up at 1, 4, 8 and 12 months post-operatively, in an open-label, randomised, 2-parallel arm, phase III superiority clinical trial. The experimental arm (Arm A) will undergo 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 leak (defunctioning stoma only if modified Anastomotic Failure Observed Risk (mAFOR) Score>/=2) and ii) if a stoma is fashioned, whether to perform an early stoma closure at day 8-12, according to clinical (fever), biochemical (CRP level on days 2 and 4 postoperatively) and radiological postoperative assessment (CT-scan with retrograde contrast enema at day 7-8 postoperatively). The control arm (Arm B) will undergo systematic use of defunctioning stoma for 2-3 months after TME for all patients, in keeping with French national and international guidelines. Secondary outcomes will include comprehensive analysis of functional outcomes (including bowel, urinary and sexual function) again up to 12 months post-operatively and a cost analysis. Regular assessments of anastomotic leak rates in both arms (every 50 randomized patients) will be performed and an independent Data Monitoring Committee will recommend trial cessation if this rate is excessive in Arm A compared to Arm B. CONCLUSION: The GRECCAR 17 trial is the first randomized trial to assess a tailored, patient-specific approach to decisions regarding defunctioning stoma use and closure after TME according to personalized risk of anastomotic leak. The results of this trial will describe, for the first time, the quality of life and morbidity impact of selective use of defunctioning ileostomy and the potential health economic effect of such an approach. | |
| dc.language.iso | EN | en_US |
| dc.subject.en | Total mesorectal excision | |
| dc.subject.en | Ileostomy | |
| dc.subject.en | Stoma | |
| dc.subject.en | Quality of life | |
| dc.title.en | A phase III randomized trial evaluating the quality of life impact of a tailored versus systematic use of defunctioning ileostomy following total mesorectal excision for rectal cancer - GRECCAR 17 trial protocol | |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1111/codi.16428 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 36413078 | en_US |
| bordeaux.journal | Colorectal Disease | en_US |
| bordeaux.page | 443-452 | |
| bordeaux.volume | 25 | |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.issue | 3 | |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | INSERM | en_US |
| bordeaux.team | PHARES_BPH | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| hal.identifier | hal-03900307 | |
| hal.version | 1 | |
| hal.date.transferred | 2022-12-15T10:21:12Z | |
| hal.export | true | |
| dc.rights.cc | Pas de Licence CC | en_US |
| bordeaux.COinS | ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Colorectal%20Disease&rft.date=2023-03&rft.volume=25&rft.issue=3&rft.spage=443-452&rft.epage=443-452&rft.eissn=1463-1318%20(Electronic)%201462-8910%20(Linking)&rft.issn=1463-1318%20(Electronic)%201462-8910%20(Linking)&rft.au=DENOST,%20Quentin&SYLLA,%20Dienabou&FLEMING,%20Christina&MAILLOU-MARTINAUD,%20Helene&PREAUBERT-HAYES,%20Nathalie&rft.genre=article |
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