Laparoscopic sigmoid resection for diverticulitis decreases major morbidity rates: a randomized control trial: short-term results of the Sigma Trial.

ABSTRACT

BACKGROUND: No randomized controlled trial has compared laparoscopic sigmoid resection (LSR) to open sigmoid resection (OSR) for symptomatic diverticulitis of the sigmoid colon. This study tested the hypothesis that LSR is associated with decreased postoperative complication rates as compared with OSR. METHODS: This was a prospective, multicenter, double-blind, parallel-arm, randomized controlled trial. Eligible patients were randomized to either LSR or OSR. Endpoints included postoperative mortality, and complications were classified as major and minor. The generator of the allocation sequence was separated from the executor. Blinding was ensured using an opaque wound dressing to cover the abdomen. Symptomatic diverticulitis of the sigmoid colon was defined as recurrent disease Hinchey I, IIa, IIb, symptomatic stricture, or severe rectal bleeding. The decision to discharge patients was made by independent physicians blind to the allocation sequence. Data were analyzed according to the intention to treat principle. RESULTS: From 2002 to 2006, 104 patients were randomized in 5 centers. All patients underwent the allocated intervention. Fifty-two LSR patients were comparable to 52 OSR patients for gender, age, BMI, ASA grade, comorbid conditions, previous abdominal surgery, and indication for surgery. LSR took longer (P = 0.0001) but caused less blood loss (P = 0.033). Conversion rate was 19.2%. Mortality rate was 1%. There were significantly more major complications in OSR patients (9.6% vs. 25.0%; P = 0.038). Minor complication rates were similar (LSR 36.5% vs. OSR 38.5%; P = 0.839). LSR patients had less pain (Visual Analog Scale 1.6; P = 0.0003), systemic analgesia requirement (P = 0.029), and returned home earlier (P = 0.046). The short form-36 questionnaire showed significantly better quality of life for LSR. CONCLUSIONS: LSR was associated with a 15.4% reduction in major complication rates, less pain, improved quality of life, and shorter hospitalization at the cost of a longer operating time.