Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial.
نویسندگان
چکیده
OBJECTIVE 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. BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.
منابع مشابه
Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial)
BACKGROUND A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study was to compare health-related quality of life (HRQOL) following early versus late closure of a temporar...
متن کاملEarly closure of temporary ileostomy—the EASY trial: protocol for a randomised controlled trial
OBJECTIVE The 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). BACKGROUND Reversal of a temporary ileostomy is generally associated with a low morbidity and mortality. Howeve...
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BACKGROUND Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents compli...
متن کاملMorbidity and mortality of temporary diverting ileostomies in rectal cancer surgery.
INTRODUCTION A temporary diverting ileostomy is frequently used to reduce the consequences of a distal anastomotic leakage after total mesorectal excision in rectal cancer surgery. This surgical technique is associated with high morbidity and a not negligible mortality. The aim of this study is to evaluate the morbidity and mortality rate associated with an ileostomy and its posterior closure. ...
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ورودعنوان ژورنال:
- Annals of surgery
دوره 265 2 شماره
صفحات -
تاریخ انتشار 2017