Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results
- Conditions
- Obesity, Morbid
- Interventions
- Procedure: sleeve gastrectomy
- Registration Number
- NCT04228185
- Lead Sponsor
- University of Rome Tor Vergata
- Brief Summary
Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term.
The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term.
Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG), and they underwent a mean follow-up of 4 years.
Patients' management was exactly the same, apart from the band placement. After surgery differences in weight loss, operative time, complication rate and mortality were analyzed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Morbid obesity
- Failure of medical treatment
- >18yrs; <60 yrs
- Previous bariatric or GI surgery
- Psychiatric disease
- Pregnancy
- Contraindication to laparoscopy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopic banded sleeve gastrectomy sleeve gastrectomy Group undergoing banded sleeve Laparoscopic sleeve gastrectomy sleeve gastrectomy Group undergoing standard sleeve
- Primary Outcome Measures
Name Time Method weight loss from surgery to 4 years follow up comparison of weight loss between the two procedures
- Secondary Outcome Measures
Name Time Method Complications from surgery to 4 years follow up Short and mid-term complications
Trial Locations
- Locations (1)
Tor Vergata University Hospital
🇮🇹Roma, Italy