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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.


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.

SUBMITTER: Massucco P 

PROVIDER: S-EPMC7896613 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

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.

Massucco Paolo P   Fontana Andrea A   Mineccia Michela M   Perotti Serena S   Ciccone Giovannino G   Galassi Claudia C   Giuffrida Maria Carmela MC   Marino Donatella D   Monsellato Igor I   Paris Myriam Katja MK   Perinotti Roberto R   Racca Patrizia P   Monagheddu Chiara C   Saccona Fabio F   Ponte Elisa E   Mistrangelo Massimiliano M   Santarelli Mauro M   Tomaselli Francesco F   Reddavid Rossella R   Birolo Simone S   Calabrò Marcello M   Pipitone Nicoletta N   Panier Suffat Luca L   Carrera Monica M   Potente Francesco F   Brunetti Marco M   Rimonda Roberto R   Adamo Vincenzo V   Piscioneri Domenico D   Cravero Francesca F   Serventi Alberto A   Giaminardi Eliana E   Mazza Luca L   Bellora Paolo P   Colli Fabio F   De Rosa Clemente C   Battafarano Francesco F   Trapani Renza R   Mellano Alfredo A   Gibin Enrico E   Bellomo Paola P  

BMJ open 20210219 2


<h4>Introduction</h4>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 recta  ...[more]

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