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- Danielsen, Anne K, et al.
(författare)
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Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial.
- 2017
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Ingår i: Annals of surgery. - 1528-1140. ; 265:2, s. 284-290
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Tidskriftsartikel (refereegranskat)abstract
- The objective was to study morbidity and mortality associated with early closure (8-13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer.A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients.Early closure (8-13 days after stoma creation) of a temporary ileostomy was compared with late closure (>12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (>12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated.The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001.It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0.
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| 3. |
- Park, Jennifer, et al.
(författare)
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Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial).
- 2020
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Ingår i: Surgical endoscopy. - : Springer Science and Business Media LLC. - 1432-2218 .- 0930-2794. ; 34:1, s. 69-76
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Tidskriftsartikel (refereegranskat)abstract
- 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 12months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial.Early closure (8-13days) of a temporary stoma was compared to late closure (>12weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12months 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.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.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.Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.
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