To Örebro University

Introduction: This randomized clinical trial evaluated the clinical outcomes of two surgical interventions for obesity treatment: single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI) and biliopancreatic diversion with duodenal switch (BPD/DS). The SADI procedure was developed as a response to the challenges posed by the BPD/DS procedure, aiming to enhance surgical efficiency, minimize postoperative risks, and maintain therapeutic efficacy. The present study primarily focused on early complications and short-term results.

Methods: Fifty-six patients with a body mass index (BMI) ranging from 42 to 72 kg/m(2) were randomly assigned to either the SADI or BPD/DS procedure. Parameters compared included % excess weight loss (%EWL), % total weight loss (%TWL), length of hospital stay (LOS), re-admission rates, and complications.

Results: Both groups had similar demographics and baseline characteristics. SADI had a mean operating time of 109 min, significantly shorter than BPD/DS at 139 min (p < 0.001). Early complications occurred in five patients in the SADI group and in four patients in the BPD/DS group with no mortality. Median LOS was 2 days for both SADI and BPD/DS. Within 30 days, one SADI patient and three BPD/DS patients required re-admission. Serious late complications necessitating reoperation were observed in three SADI and two BPD/DS patients. After 1 year, %EWL and %TWL were similar: SADI (81.8% +/- 13.6% and 40.1% +/- 5.9%) and BPD/DS (84.2% +/- 14.0% and 41.6% +/- 6.4%).

Conclusion: This trial suggests that both the SADI and BPD/DS yield comparable weight loss outcomes after 1 year, with a notable risk profile.

Trial Registration: NCT 03938571 (http://www.clinicaltrials.gov)