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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.