Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results From a Prospective Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- weight loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Morbid obesity
- •Failure of medical treatment
- •>18yrs; <60 yrs
Exclusion Criteria
- •Previous bariatric or GI surgery
- •Psychiatric disease
- •Pregnancy
- •Contraindication to laparoscopy
Outcomes
Primary Outcomes
weight loss
Time Frame: from surgery to 4 years follow up
comparison of weight loss between the two procedures
Secondary Outcomes
- Complications(from surgery to 4 years follow up)
Investigators
Stefano D'Ugo
Principal Investigator
University of Rome Tor Vergata