Not recruiting yet
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)
NCT06021873 · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated 1 Sept 2023
- What is being tested
- SADI-S
- For
- Obesity, Morbid
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 65 years. About 105 people. The full rules are on the registry page.
- Where
- Italy
- When
- Starts or started 1 Jan 2024, ends 1 Dec 2028. Registered 1 Sept 2023.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, Italy
