Status:
NOT_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)
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Obesity, Morbid
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 procedu...
Detailed Description
Patients with super-obesity (BMI≥50 kg/m2) present a significant challenge for bariatric surgeons due to the complexity of their cases. Hypo-absorptive procedures are often necessary to achieve the be...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patients eligible for Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy using a minimally invasive technique
- Informed consent
Exclusion
- Patients eligible for different bariatric procedures than SADI-S
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06021873
Start Date
January 1 2024
End Date
December 1 2028
Last Update
September 1 2023
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168