title: Diverting ileostomy versus no diversion after low anterior resection for rectal cancer: A prospective, randomized, multicenter trial.
abstract: BACKGROUND
  This study sought to determine whether a protective diverting ileostomy improves short-term outcomes in patients with rectal resection and colonic J-pouch reconstruction for low anastomoses. Criteria for the use of a proximal stoma in rectal resections with colonic J-pouch reconstruction have not been defined sufficiently.
  
  
  METHODS
  In a multicenter prospective study, rectal cancer patients with anastomoses below 8 cm treated with low anterior resection and colonic J-pouch were randomized to a defunctioning loop ileostomy or no ileostomy. The primary study endpoint was the rate of anastomotic leakage, and the secondary endpoints were surgical complications related to primary surgery, stoma, or stoma closure.
  
  
  RESULTS
  From 2004 to 2014, a total of 166 patients were randomized to 1 of the 2 study groups. In the intention-to-treat analysis, the overall leakage rate was 5.8% in the stoma group and 16.3% in the no stoma group (P = .0441). However, some patients were not treated according to randomization and only 70% of our patients with low anastomoses received a pouch. Therefore, we performed a second analysis as to actual treatment. In this analysis, as well, leakage rates (P = .044) and reoperation rates for leakage (P = .021) were significantly higher in patients without a stoma. In multivariate analysis, male gender (P = .0267) and the absence of a stoma (P = .0092) were significantly associated with anastomotic leakage.
  
  
  CONCLUSIONS
  Defunctioning loop ileostomy should be fashioned in rectal cancer patients with anastomoses below 6 cm, particularly in male patients, even if reconstruction was done with a J-pouch.
authors.affiliation: Department of Surgery, Hospital of the Brothers of Mercy, St. Veit/Glan, Austria.
authors.forename: Karl
authors.initials: K
authors.lastname: Mrak
authors.affiliation: Department of Surgery, Hospital of the Brothers of Mercy, Graz, Austria.
authors.forename: Stefan
authors.initials: S
authors.lastname: Uranitsch
authors.affiliation: Assign Data Management and Biostatistics GmbH, Innsbruck, Austria.
authors.forename: Florian
authors.initials: F
authors.lastname: Pedross
authors.affiliation: Department of Surgery, University of Salzburg, Salzburg, Austria.
authors.forename: Andreas
authors.initials: A
authors.lastname: Heuberger
authors.affiliation: Assign Data Management and Biostatistics GmbH, Innsbruck, Austria.
authors.forename: Anton
authors.initials: A
authors.lastname: Klingler
authors.affiliation: Department of Surgery, Hospital of the Brothers of Mercy, St. Veit/Glan, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Jagoditsch
authors.affiliation: Department of Surgery, Hospital of the Brothers of Mercy, St. Veit/Glan, Austria.
authors.forename: Dominik
authors.initials: D
authors.lastname: Weihs
authors.affiliation: Department of Surgery, Hospital of the Brothers of Mercy, St. Veit/Glan, Austria.
authors.forename: Thomas
authors.initials: T
authors.lastname: Eberl
authors.affiliation: Department of Surgery, Hospital of the Brothers of Mercy, St. Veit/Glan, Austria. Electronic address: joerg.tschmelitsch@bbstveit.at.
authors.forename: Jörg
authors.initials: J
authors.lastname: Tschmelitsch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000714:Anastomosis, Surgical; D057868:Anastomotic Leak / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D003106:Colon / Q000601:surgery; D039021:Colonic Pouches; D005260:Female; D006801:Humans; D007081:Ileostomy; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016737:Proctocolectomy, Restorative; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000601:surgery*; D012007:Rectum / Q000601:surgery*; D016896:Treatment Outcome