• Annals of surgery · Feb 2017

    Randomized Controlled Trial Multicenter Study Comparative Study

    Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial.

    • Anne K Danielsen, Jennifer Park, Jens E Jansen, David Bock, Stefan Skullman, Anette Wedin, Adiela Correa Marinez, Eva Haglind, Eva Angenete, and Jacob Rosenberg.
    • *Department of Gatroenterology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Ringvej, Herlev, Denmark †Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Scandinavian Surgical Outcomes Research Group, Sahlgrenska University Hospital, Östra, Gothenburg, Sweden ‡Department of Surgery, Nordsjællands Hospital, Denmark §Department of Surgery, Skaraborgs Sjukhus Skovde, Sweden.
    • Ann. Surg. 2017 Feb 1; 265 (2): 284-290.

    ObjectiveThe 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.BackgroundA 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.MethodsEarly 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.ResultsThe 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.ConclusionsIt 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.

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