Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial)

Abstract

Background: Hospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial.

Methods: Early closure (8-13 days) of a temporary stoma was compared to late closure (> 12 weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12 months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector.

Results: Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value < 0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations.

Conclusions: The significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage.

Clinical trial: Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.

Keywords: Cost analysis; Rectal cancer; Rectal resection; Temporary ileostomy.

Conflict of interest statement

Jennifer Park has received funding from the Agreement concerning research and education of doctors ALFGBG-682731. Eva Angenete reports funding from the Swedish Research Council 2012-1786, the Swedish Cancer Society 2013/500, Sahlgrenska University Hospital, Agreement concerning research and education of doctors ALFGBG-366481, ALFGBG-526501 and ALFGBG-493341, the Swedish Society of Medicine SLS-247661 and SLS-412151 and the Lions Väst Cancer Foundation. Anne K Danielsen has received funding from the Research Council at Herlev and Gentofte Hospital, Denmark. Eva Haglind reports grants from the Swedish Research Council, Swedish Cancer Society, Sahlgrenska University Hospital, ALG grant, AFA Insurance Research grant outside the submitted work. David Bock, Adiela Correa-Marinez, Jacob Gehrman, Stefan Skullman, Jens E Jansen, Anette Wedin and Jacob Rosenberg have no conflicts of interest or financial ties to disclose.

Figures

Fig. 1

Study flow chart. *Excluded after clinical evaluation (n = 91), diabetes (n = 28), permanent or no stoma (n = 29), steroid treatment (n = 3), other (n = 8). **Centre 6 (n = 2), centre 7 (n = 3) and centre 8 (n = 3). †One patient died within 12 months (237 days). ††One patient died within 12 months (294 days). Figure has previously published in Danielsen et al. [12] and Park et al. [16]