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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?

SUBMITTER: Park J

PROVIDER: S-EPMC6946724 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Park Jennifer J Angenete Eva E Bock David D Correa-Marinez Adiela A Danielsen Anne K AK Gehrman Jacob J Haglind Eva E Jansen Jens E JE Skullman Stefan S Wedin Anette A Rosenberg Jacob J

Surgical endoscopy 20190325 1

<h4>Background</h4>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 ...[more]

PMID: 30911920

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Project description:ObjectiveThe objective is to evaluate efficiency based on data on morbidity and mortality, health-related quality of life and healthcare-related costs after early reversal of temporary ileostomy after rectal resection for cancer compared with the standard procedure (late reversal).BackgroundReversal of a temporary ileostomy is generally associated with a low morbidity and mortality. However, ostomy reversal may cause complications requiring reoperation with subsequent major complications, in ranges from 0% to 7-9% and minor complications varying from 4-5% to 30%. Based on studies exploring and describing the time of closure in previous studies which are mostly of low quality, a recent review concluded that closing a temporary stoma within 2 weeks did not seem to be associated with an increase in morbidity and mortality.Design and methodsEarly closure of temporary ileostomy (EASY), a randomised controlled trial, is a prospective randomised controlled multicentre study which is performed within the framework of the Scandinavian Surgical Outcomes Research Group (http://www.ssorg.net/) and plans to include 200 patients from Danish and Swedish hospitals. The primary end-point of the study is the frequency of complications 0-12 months after surgery (the stoma creation operation). The secondary end-points of the study are (1) comparison of the total costs of the two groups at 6 and 12 months after surgery (stoma creation); (2) comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6 and 12 months after surgery (stoma creation); and (3) comparison of disease-specific quality of life in the two groups at 3, 6 and 12 months after surgery (stoma creation).DiscussionThe aim of the EASY trial is to evaluate the efficiency of early reversal of temporary ileostomy after surgery for rectal cancer versus late reversal. The EASY trial is expected to have a huge impact on patient safety as well as an improvement in patient-reported outcome. Clinical trials identifier NCT01287637.

Project description:INTRODUCTION:A defunctioning ileostomy is often formed during rectal cancer surgery to reduce the potentially fatal sequelae of anastomotic leak. Once the ileostomy is closed and bowel continuity restored, many patients can suffer poor bowel function, that is, low anterior resection syndrome (LARS). It has been suggested that delay to closure can increase incidence of LARS which is known to significantly reduce quality of life. Despite this, within the UK, time to closure of ileostomy is not subject to national targets within the National Health Service and delay to closure exceeds 18 months in one-third of patients. Clinical factors, surgeon and patient preference or service pressures may all impact time to closure, yet to date no study has investigated this. The aim of this UK-wide study is to assess time to ileostomy closure and identify reasons for delays. METHODS AND ANALYSIS:A UK-wide multicentre prospective snapshot study, together with retrospective analysis of ileostomy closure through The Dukes' Club Research Collaborative including patients undergoing ileostomy closure in a 3-month period (April to June 2018) and all patients who underwent anterior resection and ileostomy formation over a historical 12-month period (2015). Time to closure and incidence of 'non-closure' will be calculated. Units will be surveyed to determine local clinical and management protocols and barriers to timely closure. Multivariate linear regression analysis will be used to determine factors significantly associated with delay to ileostomy closure. ETHICS AND DISSEMINATION:Study approved by the South West-Exeter Research Ethics Committee and the Health Research Authority. Study results will be submitted for presentation at international conferences and for publication in peer-reviewed journals. Results will be presented to and discussed with the patient and public representatives and relevant national bodies to facilitate the development of consensus guidelines on optimum treatment pathways.

Dataset Information

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

Publications

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

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