Evaluation of the Non-inferiority of the Robotic Approach Over the Laparoscopic Approach in Patients Who Are Candidates for Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S)

Condition(s) studied

Investigational drug(s) / intervention(s)

SADI-S: Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy

Study summary

Treating patients with super-obesity has always been challenging for bariatric surgeons due to the higher risk of postoperative complications and the limited success of commonly used bariatric procedures (restrictive and hypo-absorptive). In this context, these patients are often considered for more complex procedures, such as hypo-absorptive interventions. Over the past 15 years, a new hypo-absorptive procedure called single-anastomosis duodenal switch with biliopancreatic diversion (SADI-S) has been introduced and recognized as a bariatric procedure by leading national and international scientific societies. It has shown promising short- and medium-term results regarding weight loss and metabolic improvements.

The SADI-S procedure is a technically complex multi-quadrant surgery. This study aims to evaluate the equivalence in terms of morbidity between laparoscopic and robotic approaches for patients undergoing this procedure.

Eligibility

Primary outcome measure(s)

• Evaluation of post-operative complications — 30 days
  Comparison between the laparoscopic and robotic approach to Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy in order to evaluate the post-operative complications rate within 30 days from the surgical procedure. Complications will be expressed in absolute numbers and divided into major complications (grade III-IV) and minor complications (grade I-II) according to the Clavien-Dindo classification.

Trial sites (1)

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