Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before or after ADjuvant therapy) randomised controlled trial
Open Access
- 19 February 2021
- Vol. 11 (2), e044692
- https://doi.org/10.1136/bmjopen-2020-044692
Abstract
Introduction Temporary ileostomy is a valuable aid in reducing the severity of complications related to rectal cancer surgery. However, it is still unclear what is the best timing of its closure in relation to the feasibility of an adjuvant treatment, especially considering patient-reported outcomes and health system costs. The aim of the study is to compare the results of an early versus late closure strategy in patients with indication to adjuvant chemotherapy after resection for rectal cancer. Methods and analysis This is a prospective multicentre randomised trial, sponsored by Rete Oncologica Piemonte e Valle d’Aosta (Oncology Network of Piedmont and Aosta Valley-Italy). Patients undergone to rectal cancer surgery with temporary ileostomy, aged >18 years, without evidence of anastomotic leak and with indication to adjuvant chemotherapy will be enrolled in 28 Network centres. An early closure strategy (between 30 and 40 days from rectal surgery) will be compared with a late one (after the end of adjuvant therapy). Primary endpoint will be the compliance to adjuvant chemotherapy with and without ileostomy. Complications associated with stoma closure as well as quality of life, costs and oncological outcomes will be assessed as secondary endpoints. Ethics and dissemination The trial will engage the Network professional teams in a common effort to improve the treatment of rectal cancer by ensuring the best results in relation to the most correct use of resources. It will take into consideration both the patients’ point of view (patient-reported outcome) and the health system perspective (costs analysis). The study has been approved by the Ethical Review Board of Città della Salute e della Scienza Hospital in Turin (Italy). The results of the study will be disseminated by the Network website, medical conferences and peer-reviewed scientific journals. Trial registration number NCT04372992.This publication has 16 references indexed in Scilit:
- Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial)Surgical Endoscopy, 2019
- Functional outcomes from a randomized trial of early closure of temporary ileostomy after rectal excision for cancerBritish Journal of Surgery, 2019
- The incidence of stoma related morbidity – a systematic review of randomised controlled trialsThe Annals of The Royal College of Surgeons of England, 2018
- Early Closure of a Temporary Ileostomy in Patients With Rectal CancerAnnals of Surgery, 2017
- Quality of Life and Timing of Stoma Closure in Patients With Rectal Cancer Undergoing Low Anterior Resection With Diverting StomaDiseases of the Colon & Rectum, 2016
- Should a loop ileostomy closure in rectal cancer patients be done during or after adjuvant chemotherapy?Journal of Surgical Oncology, 2013
- Association Between Time to Initiation of Adjuvant Chemotherapy and Survival in Colorectal CancerJAMA, 2011
- Covering ileo- or colostomy in anterior resection for rectal carcinomaEmergencias, 2010
- Randomized clinical trial of early versus delayed temporary stoma closure after proctectomyBritish Journal of Surgery, 2008
- Living with a stoma: a review of the literatureJournal of Clinical Nursing, 2005