Background
The short-term results of the Sigma-trial, comparing laparoscopic (LSR) versus open (OSR) elective sigmoid resection for diverticular disease, showed a 15.4% reduction in major complication rates, less pain, and shorter hospitalization at the cost of a longer operating time. Present data complements these results with six months follow-up.
Methods
This was a prospective, multi-center, double-blind, parallel-arm, randomized control trial, eligible patients were randomized to either LSR or OSR. Short-term results of the Sigma-trial have been published previously, methodological and operative details can be found in this original article. Patients attended the outpatient clinic six weeks and six months after surgery. Physical examination was carried out and the quality of life questionnaires were completed. In case of readmission, medical records were prospectively evaluated. Primary endpoints were mortality and late complications occurring between 30 days from surgery until six months postoperative.
Results
From 2002 to 2006, 104 patients were randomized in five centers. All patients underwent the allocated intervention. 52 LSR patients were comparable to 52 OSR patients for gender, age, BMI, ASA grade, comorbid conditions, previous abdominal surgery, and indication for surgery. Conversion rate was 19.2%. LSR was associated with short-term benefits like a 15.4% reduction in major complication rates, less pain, and shorter hospitalization at the cost of a longer operating time. At six months follow up no significant differences in morbidity and mortality rates were found. Two patients died of cardiopulmonal causes (overall mortality 3%). Late complications (LSR 7 vs. 12 OSR; p = .205) consist of three incisional hernias, five times ileus, four fistulas, one abscess, two anastomotic stenoses and three recurrent episodes of diverticulitis. Nine of these patients underwent additional surgical interventions. Only 30% of ten ostomies were reversed during the follow-up period. The Short Form-36 (SF-36) questionnaire showed significantly better quality of life for LSR at the six weeks follow-up, but at the six moths follow-up these differences were decreased.
Conclusions
Six months follow-up showed an overall mortality rate of 3% and a complication rate of 18%. No significant differences were found between LSR and OSR in terms of complications, re-interventions or ostomy reversal.
Session: Podium Presentation
Program Number: S085