PURPOSE:Elective laparoscopic sigmoid resection (LSR) for symptomatic diverticular disease is supposed to have significant short-term advantages compared to open surgery (open sigmoid resection (OSR)). This opinion is rather based on inferences from trials on colonic resections for malignant diseases or minor laparoscopic surgery. This randomized controlled trial was conducted to compare quality of life as well as morbidity and clinical outcome after LSR vs. OSR following a midterm follow-up period. METHODS:Patients presenting with a symptomatic sigmoid diverticular disease stage II/III (Stock/Hansen) were randomly allocated to LSR or OSR in a prospective multicenter trial. Endpoints included the quality of life assessed with a standardized questionnaire, postoperative mortality, and complications within the follow-up of 12 months after operation. RESULTS: A total of 143 patients randomized between 2005 and 2008 in 12 centers could be analyzed. The recruitment was aborted for nonachievement of the planned sample size. Seventy-five patients were allocated to LSR, and 68 receivedOSR. Nine operations were converted to OSR (9%) and analyzed as intention to treat. Groups were comparable for age, gender, body mass index, comorbidity, and indication for surgery. Operation time was longer for LSR (p < 0.001). Quality of life did not differ between LSR and OSR, either during the early postoperative course or after 12 months (p = 0.172). Also, mortality and morbidity, including subgroups of major and minor morbidity, were compared. CONCLUSION:LSR was not superior to OSR regarding postoperative quality of life and incidence of complications in this trial.
RCT Entities:
PURPOSE: Elective laparoscopic sigmoid resection (LSR) for symptomatic diverticular disease is supposed to have significant short-term advantages compared to open surgery (open sigmoid resection (OSR)). This opinion is rather based on inferences from trials on colonic resections for malignant diseases or minor laparoscopic surgery. This randomized controlled trial was conducted to compare quality of life as well as morbidity and clinical outcome after LSR vs. OSR following a midterm follow-up period. METHODS:Patients presenting with a symptomatic sigmoid diverticular disease stage II/III (Stock/Hansen) were randomly allocated to LSR or OSR in a prospective multicenter trial. Endpoints included the quality of life assessed with a standardized questionnaire, postoperative mortality, and complications within the follow-up of 12 months after operation. RESULTS: A total of 143 patients randomized between 2005 and 2008 in 12 centers could be analyzed. The recruitment was aborted for nonachievement of the planned sample size. Seventy-five patients were allocated to LSR, and 68 received OSR. Nine operations were converted to OSR (9%) and analyzed as intention to treat. Groups were comparable for age, gender, body mass index, comorbidity, and indication for surgery. Operation time was longer for LSR (p < 0.001). Quality of life did not differ between LSR and OSR, either during the early postoperative course or after 12 months (p = 0.172). Also, mortality and morbidity, including subgroups of major and minor morbidity, were compared. CONCLUSION: LSR was not superior to OSR regarding postoperative quality of life and incidence of complications in this trial.
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