Abstract
IMPORTANCE: A laparoscopic approach for adhesive small bowel obstruction (SBO) requiring surgery provides quicker recovery compared with open surgery, but benefits in long-term follow-up are unclear. OBJECTIVE: To compare SBO recurrence, incisional hernia, and quality of life (QOL) outcomes in long-term follow-up after laparoscopic vs open surgery. DESIGN, SETTING, AND PARTICIPANTS: The Laparoscopic vs Open Adhesiolysis for Adhesive Small Bowel Obstruction (LASSO) randomized clinical trial was conducted in 8 hospitals in Finland and Italy between July 2013 and April 2018. In this study, the 5-year follow-up is reported. This was an international, multicenter, parallel, open-label randomized clinical trial including patients with clinical and radiological signs of adhesive SBO not resolving by conservative means. Study data were analyzed from February to May 2025. INTERVENTIONS: Open vs laparoscopic adhesiolysis. MAIN OUTCOMES AND MEASURES: SBO recurrence rate, incisional hernia incidence and QOL (Gastrointestinal Quality Of Life Index [GIQLI] and 36-item Short-Form Health Survey [SF-36]) within 5 years are reported using modified intention-to-treat and post hoc per-protocol analyses. RESULTS: A total of 104 patients were randomized, and 100 (mean [SD] age, 69.2 [15.7] years; 65 female [65%]) were included in the analyses (49 in open surgery, 51 in laparoscopic surgery). At 1 year, 1 patient (2.3%) in the open-surgery group had recurrent SBO vs 2 patients (4.5%) in the laparoscopy group (odds ratio [OR], 2.05; 95% CI, 0.18-23.44; P >.99). Within 5 years, 3 patients (9.7%) in the open-surgery group had at least 1 recurrent SBO vs 4 patients (12.5%) in the laparoscopy group (OR, 1.33; 95% CI, 0.27-6.51; P >.99). Incisional hernias were detected in 2 patients (6.1%) in the open-surgery group vs 2 patients (6.3%) in the laparoscopy group (OR, 1.03; 95% CI, 0.14-7.82; P >.99). At 5-year follow-up, median (IQR) SF-36 score was 73.2 (52.8-85.9) in the open-surgery group and 67.1 (42.6-76.7) in the laparoscopy group (P = .23), and median (IQR) GIQLI scores were 118 (95-136) in the open-surgery group and 119 (102-129) in the laparoscopy group (P = .54). CONCLUSIONS AND RELEVANCE: Results of this randomized clinical trial reveal that, although the laparoscopic approach to adhesive SBO has small short-term benefits, it was not superior to open surgery based on long-term follow-up. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01867528.