Long-Term Outcomes After Laparoscopic vs Open Adhesiolysis for Small Bowel Obstruction: The LASSO Randomized Clinical Trial

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.