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NCT06021873Not yet recruiting

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)

Source: ClinicalTrials.gov · Last updated 1 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
105 (estimated)
First submitted
10 Jul 2023
Start date
1 Jan 2024
Primary completion date
1 Aug 2028
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Diseases
Obesity
NCT number
NCT06021873

What you commit to

  • Study type: Interventional
  • Planned participants: 105
  • From 1 Jan 2024 to the primary completion date, 1 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patients eligible for different bariatric procedures than SADI-S

Who the study is looking for

  • Age ≥ 18 years
  • Patients eligible for Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy using a minimally invasive technique
  • Informed consent

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.