title: A multicenter randomized clinical trial of primary anastomosis or Hartmann's procedure for perforated left colonic diverticulitis with purulent or fecal peritonitis.
abstract: OBJECTIVE
  To evaluate the outcome after Hartmann's procedure (HP) versus primary anastomosis (PA) with diverting ileostomy for perforated left-sided diverticulitis.
  
  
  BACKGROUND
  The surgical management of left-sided colonic perforation with purulent or fecal peritonitis remains controversial. PA with ileostomy seems to be superior to HP; however, results in the literature are affected by a significant selection bias. No randomized clinical trial has yet compared the 2 procedures.
  
  
  METHODS
  Sixty-two patients with acute left-sided colonic perforation (Hinchey III and IV) from 4 centers were randomized to HP (n = 30) and to PA (with diverting ileostomy, n = 32), with a planned stoma reversal operation after 3 months in both groups. Data were analyzed on an intention-to-treat basis. The primary end point was the overall complication rate. The study was discontinued following an interim analysis that found significant differences of relevant secondary end points as well as a decreasing accrual rate (NCT01233713).
  
  
  RESULTS
  Patient demographics were equally distributed in both groups (Hinchey III: 76% vs 75% and Hinchey IV: 24% vs 25%, for HP vs PA, respectively). The overall complication rate for both resection and stoma reversal operations was comparable (80% vs 84%, P = 0.813). Although the outcome after the initial colon resection did not show any significant differences (mortality 13% vs 9% and morbidity 67% vs 75% in HP vs PA), the stoma reversal rate after PA with diverting ileostomy was higher (90% vs 57%, P = 0.005) and serious complications (Grades IIIb-IV: 0% vs 20%, P = 0.046), operating time (73 minutes vs 183 minutes, P < 0.001), hospital stay (6 days vs 9 days, P = 0.016), and lower in-hospital costs (US $16,717 vs US $24,014) were significantly reduced in the PA group.
  
  
  CONCLUSIONS
  This is the first randomized clinical trial favoring PA with diverting ileostomy over HP in patients with perforated diverticulitis.
authors.affiliation: Department of Surgery, University Hospital Zurich, Raemistrasse 100, Zurich, Switzerland.
authors.forename: Christian Eugen
authors.initials: CE
authors.lastname: Oberkofler
authors.forename: Andreas
authors.initials: A
authors.lastname: Rickenbacher
authors.forename: Dimitri Aristotle
authors.initials: DA
authors.lastname: Raptis
authors.forename: Kuno
authors.initials: K
authors.lastname: Lehmann
authors.forename: Peter
authors.initials: P
authors.lastname: Villiger
authors.forename: Christian
authors.initials: C
authors.lastname: Buchli
authors.forename: Felix
authors.initials: F
authors.lastname: Grieder
authors.forename: Hans
authors.initials: H
authors.lastname: Gelpke
authors.forename: Marco
authors.initials: M
authors.lastname: Decurtins
authors.forename: Adrien A
authors.initials: AA
authors.lastname: Tempia-Caliera
authors.forename: Nicolas
authors.initials: N
authors.lastname: Demartines
authors.forename: Dieter
authors.initials: D
authors.lastname: Hahnloser
authors.forename: Pierre-Alain
authors.initials: PA
authors.lastname: Clavien
authors.forename: Stefan
authors.initials: S
authors.lastname: Breitenstein
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000714:Anastomosis, Surgical; D016009:Chi-Square Distribution; D004239:Diverticulitis, Colonic / Q000601:surgery*; D005260:Female; D006801:Humans; D007081:Ileostomy / Q000379:methods*; D007416:Intestinal Perforation / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010538:Peritonitis / Q000601:surgery*; D011183:Postoperative Complications; D018709:Statistics, Nonparametric; D013557:Switzerland; D016896:Treatment Outcome