The HUGO-SLEEVE Trial is a prospective, single-center, single-arm interventional study designed to evaluate the feasibility and safety of robotic sleeve gastrectomy using the Hugo™ Robotic-Assisted Surgery System, including the LigaSure™ RAS vessel sealing device, during the early phase of clinical implementation. The study investigates whether the procedure can be performed safely and reliably.
The primary endpoint is the proportion of procedures completed without conversion. Secondary endpoints include intraoperative parameters (port placement time, docking time, console time, total operative time, and intraoperative complications) as well as postoperative outcomes (complications, length of hospital stay, readmissions, reoperations, postoperative pain, time to oral intake and mobilization, and changes in SF-Bari Score).
A total of 50 consecutive patients with a body mass index (BMI) ≥ 40 kg/m² or a BMI ≥ 35 kg/m² in the presence of at least one obesity-related comorbidity who are scheduled to undergo elective primary sleeve gastrectomy will be enrolled. Postoperative follow-up assessments will be performed on postoperative days 1, 2, 3, 30, 90, and 180.
