前瞻性、随机、多中心、开放标签试验，旨在评估接受直肠癌切除术且有辅助化疗指征的患者中临时回肠造口关闭的最佳时机（早期与晚期）：STOMAD（辅助治疗前或后造口关闭）随机对照试验。
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.
作者信息
Massucco Paolo, Fontana Andrea, Mineccia Michela, Perotti Serena, Ciccone Giovannino, Galassi Claudia, Giuffrida Maria Carmela, Marino Donatella, Monsellato Igor, Paris Myriam Katja, Perinotti Roberto, Racca Patrizia, Monagheddu Chiara, Saccona Fabio, Ponte Elisa, Mistrangelo Massimiliano, Santarelli Mauro, Tomaselli Francesco, Reddavid Rossella, Birolo Simone, Calabrò Marcello, Pipitone Nicoletta, Panier Suffat Luca, Carrera Monica, Potente Francesco, Brunetti Marco, Rimonda Roberto, Adamo Vincenzo, Piscioneri Domenico, Cravero Francesca, Serventi Alberto, Giaminardi Eliana, Mazza Luca, Bellora Paolo, Colli Fabio, De Rosa Clemente, Battafarano Francesco, Trapani Renza, Mellano Alfredo, Gibin Enrico, Bellomo Paola
机构信息
Department of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy
Department of General and Oncological Surgery, Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.
出版信息
BMJ Open. 2021 Feb 19;11(2):e044692. doi: 10.1136/bmjopen-2020-044692.
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.
引言
临时回肠造口术对于降低直肠癌手术相关并发症的严重程度具有重要作用。然而，关于其关闭的最佳时机与辅助治疗可行性之间的关系仍不明确，尤其是考虑到患者报告的结局和卫生系统成本。本研究的目的是比较直肠癌切除术后有辅助化疗指征的患者采用早期与晚期关闭策略的结果。
方法与分析
这是一项由意大利皮埃蒙特和奥斯塔山谷肿瘤网络（Rete Oncologica Piemonte e Valle d'Aosta）赞助的前瞻性多中心随机试验。年龄>18岁、无吻合口漏证据且有辅助化疗指征、接受了带临时回肠造口术的直肠癌手术的患者将在28个网络中心入组。将早期关闭策略（直肠癌手术后30至40天之间）与晚期关闭策略（辅助治疗结束后）进行比较。主要终点将是有或无回肠造口术时辅助化疗的依从性。将与造口关闭相关的并发症以及生活质量、成本和肿瘤学结局作为次要终点进行评估。
伦理与传播
该试验将促使网络专业团队共同努力，通过确保在最正确使用资源方面取得最佳结果来改善直肠癌的治疗。它将兼顾患者的观点（患者报告的结局）和卫生系统的观点（成本分析）。该研究已获得意大利都灵市健康与科学医院伦理审查委员会的批准。研究结果将通过网络网站、医学会议和同行评审的科学期刊进行传播。
试验注册号
NCT04372992。
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