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

@entity1 @entity548 @entity190 @entity260 @entity158 @entity4436
BACKGROUND: No randomized controlled trial has compared laparoscopic sigmoid resection (LSR) to open sigmoid resection (OSR) for symptomatic @entity4436 of the sigmoid colon. This study tested the hypothesis that LSR is associated with @entity260 rates as compared with OSR. METHODS: This was a prospective, multicenter, double-blind, parallel-arm, randomized controlled trial. Eligible @entity1 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 @entity4436 of the sigmoid colon was defined as recurrent disease Hinchey I, IIa, IIb, symptomatic stricture, or severe @entity548 . The decision to discharge @entity1 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 @entity1 were randomized in 5 centers. All @entity1 underwent the allocated intervention. Fifty-two LSR @entity1 were comparable to 52 OSR @entity1 for gender, age, BMI, ASA grade, comorbid conditions, previous abdominal surgery, and indication for surgery. LSR took longer (P = 0.0001) but caused less @entity190 (P = 0.033). Conversion rate was 19.2%. Mortality rate was 1%. There were significantly more major complications in OSR @entity1 (9.6% vs. 25.0%; P = 0.038). Minor complication rates were similar (LSR 36.5% vs. OSR 38.5%; P = 0.839). LSR @entity1 had @entity158 (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, @entity158 , improved quality of life, and shorter hospitalization at the cost of a longer operating time.
