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
Vincenzo Adamo,
Paolo Massucco,
Andrea Fontana,
Michela Mineccia,
Serena Perotti,
Giovannino Ciccone,
Claudia Galassi,
Maria Carmela Giuffrida,
Donatella Marino,
Igor Monsellato,
Myriam Katja Paris,
Roberto Perinotti,
Patrizia Racca,
Chiara Monagheddu,
Fabio Saccona,
Elisa Ponte,
Massimiliano Mistrangelo,
Mauro Santarelli,
Francesco Tomaselli,
Rossella Reddavid,
Simone Birolo,
Marcello Calabrò,
Nicoletta Pipitone,
Luca Panier Suffat,
Monica Carrera,
Francesco Potente,
Marco Brunetti,
Roberto Rimonda,
Domenico Piscioneri,
Francesca Cravero,
Alberto Serventi,
Eliana Giaminardi,
Luca Mazza,
Paolo Bellora,
Fabio Colli,
Clemente De Rosa,
Francesco Battafarano,
Renza Trapani,
Alfredo Mellano,
Enrico Gibin,
Paola Bellomo
Affiliations
Vincenzo Adamo
5 Medical Oncology, Department of Human Pathology, A.O. Papardo, University of Messina, Messina, Italy
Paolo Massucco
4 General Surgery and Oncology Unit, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy
Andrea Fontana
Unit of Biostatistics, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
Michela Mineccia
Department of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy
Serena Perotti
Department of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy
Giovannino Ciccone
1 Unit of Clinical Epidemiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy
Claudia Galassi
Clinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy
Maria Carmela Giuffrida
Department of Surgery, Azienda Ospedaliera S Croce e Carle, Cuneo, Italy
Donatella Marino
Department of Oncology, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy
Igor Monsellato
Department of Surgery, Azienda Ospedaliera Nazionale SS Antonio e Biagio e C Arrigo, Alessandria, Italy
Myriam Katja Paris
Department of Oncology, Ospedale degli Infermi, Ponderano (BI), Italy
Roberto Perinotti
Department of Surgery, Ospedale degli Infermi, Ponderano (BI), Italy
Patrizia Racca
Colorectal Cancer Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy
Chiara Monagheddu
Clinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy
Fabio Saccona
Clinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy
Elisa Ponte
Department of Surgery, Ospedale Regionale Umberto Parini, Aosta, Italy
Massimiliano Mistrangelo
Department of Surgical Science, Turin University, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy
Mauro Santarelli
Department of General and Emergency Surgery, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy
Francesco Tomaselli
Department of Surgery, Ospedale Martini, Torino, Italy
Rossella Reddavid
Department of Surgical Oncology and Digestive Surgery, Turin University, Azienda Ospedaliero Universitaria San Luigi Gonzaga, Orbassano (TO), Italy
Simone Birolo
Department of Surgery, Ospedale degli Infermi, Rivoli (TO), Italy
Marcello Calabrò
Department of Surgery, Ospedale Edoardo Agnelli, Pinerolo (TO), Italy
Nicoletta Pipitone
Department of Surgery, Ospedale Edoardo Agnelli, Pinerolo (TO), Italy
Luca Panier Suffat
Department of Surgery, Ospedale di Ivrea, Ivrea (TO), Italy
Monica Carrera
Department of Surgery, Ospedale di Ciriè, Ciriè (TO), Italy
Francesco Potente
Department of Surgery, Ospedale Santa Croce, Moncalieri (TO), Italy
Marco Brunetti
Department of Surgery, Ospedale SS Annunziata, Savigliano (CN), Italy
Roberto Rimonda
Department of Surgery, Ospedale Regina Montis, Mondovì (CN), Italy
Domenico Piscioneri
Department of Surgery, Azienda Ospedaliera Nazionale SS Antonio e Biagio e C Arrigo, Alessandria, Italy
Francesca Cravero
Department of Surgery, Ospedale Santo Spirito, Casale Monferrato (AL), Italy
Alberto Serventi
Department of Surgery, Ospedale Mons. Galliano, Acqui Terme (AL), Italy
Eliana Giaminardi
Department of Surgery, Ospedale San Giacomo, Novi Ligure (AL), Italy
Luca Mazza
Department of Surgery, Ospedale Cardinal Massaia, Asti, Italy
Paolo Bellora
Department of Surgery, Eastern Piedmont University, Azienda Ospedaliera Maggiore della Carita, Novara, Italy
Fabio Colli
Department of Surgery, Azienda Ospedaliera Maggiore della Carità, Novara, Italy
Clemente De Rosa
Department of Surgery, Presidio Ospedaliero SantAndrea, Vercelli, Italy
Francesco Battafarano
Department of Surgery, Ospedale S. Biagio, Domodossola (VB), Italy
Renza Trapani
Department of Surgery, Ospedale Castelli, Verbania (VB), Italy
Alfredo Mellano
2 Surgical Oncology Department, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Torino, Italy
Enrico Gibin
Department of Surgery, Presidio Sanitario Ospedale Cottolengo, Torino, Italy
Paola Bellomo
8 General Surgery, Presidio Sanitario Gradenigo, Torino, Italy
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.
