ABSTRACT

Objectives

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 two procedures.

Methods

Sixty-two patients with acute left-sided colonic perforation (Hinchey III and IV) from four 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 endpoint was the overall complication rate. The study was discontinued following an interim analysis that found significant differences of relevant secondary endpoints as well as a decreasing accrual rate.

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.