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

IntroductionTemporary 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 analysisThis 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 disseminationThe 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 numberNCT04372992.

Novel nomogram for predicting risk of early postoperative small bowel obstruction after right colectomy for cancer

“…Previous studies also reported that EPSBO inhibited early oral intake and early ambulation, prolonged postoperative hospital stay, increased cost of hospitalization, and reduced utilization rate of hospital beds [ 6 ]. In addition, extension of hospital stay leads to the inability of patients to undergo timely postoperative adjuvant therapy (less than 8 weeks), which reduces the effectiveness of adjuvant therapy in patients with colorectal cancer [ 7 ]. There have study also showed that EPSBO was an independent risk factor for secondary adhesive intestinal obstruction [ 8 ].…”

Is better early closure compared to late closure of temporary ileostomy in rectal cancer? A randomized controlled trial study

“…In the present study, we also evaluated Lars score and association with QOL, and the results were truly remarkable so that all domains of QOL according to SF-36 were better and showed a signi cant difference in the early closure. On the contrary, Andreas's study demonstrated that early stoma closure was associated with higher morbidity rather than late closure [17].…”

Causes and costs of delayed closure of ileostomies in rectal cancer patients in Australasian units

“…Given recent meta‐analyses showing comparable outcomes with closure of DLIs during adjuvant therapy, 31 it is time to question this dogmatic practice. This issue is being addressed with a prospective randomized trial; the STOMAD RCT 32 which is currently in recruitment.…”