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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.
ClinicalTrials.gov, NCT06021873

Sites

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, Italy