Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results

Not Applicable

Completed

• Conditions: Obesity, Morbid

• 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

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-01
• Study Completion: 2019-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-11
• Last Update Submitted: 2020-01-11
• Study First Posted: 2020-01-14
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Morbid obesity
• Failure of medical treatment
• >18yrs; <60 yrs

Exclusion Criteria

• Previous bariatric or GI surgery
• Psychiatric disease
• Pregnancy
• Contraindication to laparoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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