학술논문
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.
Document Type
Academic Journal
Author
Massucco P; Department of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy pmassucco@mauriziano.it.; Fontana A; Department of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.; Mineccia M; Department of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.; Perotti S; Department of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.; Ciccone G; Clinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.; Galassi C; Clinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.; Giuffrida MC; Department of Surgery, Azienda Ospedaliera S Croce e Carle, Cuneo, Italy.; Marino D; Department of Oncology, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.; Monsellato I; Department of Surgery, Azienda Ospedaliera Nazionale SS Antonio e Biagio e C Arrigo, Alessandria, Italy.; Paris MK; Department of Oncology, Ospedale degli Infermi, Ponderano (BI), Italy.; Perinotti R; Department of Surgery, Ospedale degli Infermi, Ponderano (BI), Italy.; Racca P; Colorectal Cancer Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.; Monagheddu C; Clinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.; Saccona F; Clinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.; Ponte E; Department of Surgery, Ospedale Regionale Umberto Parini, Aosta, Italy.; Mistrangelo M; Department of Surgical Science, Turin University, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.; Santarelli M; Department of General and Emergency Surgery, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy.; Tomaselli F; Department of Surgery, Ospedale Martini, Torino, Italy.; Reddavid R; Department of Surgical Oncology and Digestive Surgery, Turin University, Azienda Ospedaliero Universitaria San Luigi Gonzaga, Orbassano (TO), Italy.; Birolo S; Department of Surgery, Ospedale degli Infermi, Rivoli (TO), Italy.; Calabrò M; Department of Surgery, Ospedale Edoardo Agnelli, Pinerolo (TO), Italy.; Pipitone N; Department of Surgery, Ospedale Edoardo Agnelli, Pinerolo (TO), Italy.; Panier Suffat L; Department of Surgery, Ospedale di Ivrea, Ivrea (TO), Italy.; Carrera M; Department of Surgery, Ospedale di Ciriè, Ciriè (TO), Italy.; Potente F; Department of Surgery, Ospedale Santa Croce, Moncalieri (TO), Italy.; Brunetti M; Department of Surgery, Ospedale SS Annunziata, Savigliano (CN), Italy.; Rimonda R; Department of Surgery, Ospedale Regina Montis, Mondovì (CN), Italy.; Adamo V; Department of Surgery, Ospedale San Lazzaro, Alba (CN), Italy.; Piscioneri D; Department of Surgery, Azienda Ospedaliera Nazionale SS Antonio e Biagio e C Arrigo, Alessandria, Italy.; Cravero F; Department of Surgery, Ospedale Santo Spirito, Casale Monferrato (AL), Italy.; Serventi A; Department of Surgery, Ospedale Mons. Galliano, Acqui Terme (AL), Italy.; Giaminardi E; Department of Surgery, Ospedale San Giacomo, Novi Ligure (AL), Italy.; Mazza L; Department of Surgery, Ospedale Cardinal Massaia, Asti, Italy.; Bellora P; Department of Surgery, Eastern Piedmont University, Azienda Ospedaliera Maggiore della Carita, Novara, Italy.; Colli F; Department of Surgery, Azienda Ospedaliera Maggiore della Carità, Novara, Italy.; De Rosa C; Department of Surgery, Presidio Ospedaliero Sant'Andrea, Vercelli, Italy.; Battafarano F; Department of Surgery, Ospedale S. Biagio, Domodossola (VB), Italy.; Trapani R; Department of Surgery, Ospedale Castelli, Verbania (VB), Italy.; Mellano A; Colorectal Surgical Unit, IRCCS, Candiolo (TO), Italy.; Gibin E; Department of Surgery, Presidio Sanitario Ospedale Cottolengo, Torino, Italy.; Bellomo P; Department of Surgery, Humanitas Gradenigo, Torino, Italy.
Source
Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Subject
Language
English
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.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)