Laparoscopic Banded Sleeve Gastrectomy

Completed

• Conditions: Surgery; Obesity, Morbid
• Interventions: Procedure: Laparoscopic Banded Sleeve Gastrectomy

• Registration Number: NCT04354532
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is reported to happen in up to 75.6% of patients after 6 years. The Investigators report the overall experience with Laparoscopic Banded Sleeve Gastrectomy (LBSG) using the Minimizer over a six-year period.

Detailed Description

Introduction. Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is reported to happen in up to 75.6% of patients after 6 years. The investigators report the overall experience with Laparoscopic Banded Sleeve Gastrectomy (LBSG) using the Minimizer over a six-year period.

Methods. The investigators performed a retrospective review of data from a prospectively collected database. All patients submitted to primary LBSG were examined. Patients were submitted to LBSG between February 2014 and January 2020. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.

Study Timeline

• Study Start: 2014-02-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-18
• Last Update Submitted: 2020-04-18
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

• Severe Obesity with BMI > 35 kg/m2

Exclusion Criteria

• Alcoholism
• Drug addiction
• Psychiatric Disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
209 patients were submitted to primary LBSG	Laparoscopic Banded Sleeve Gastrectomy	All patients submitted to primary Laparoscopic Banded Sleeve Gastrectomy were examined. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.

Primary Outcome Measures

Name	Time	Method
% Excess Weight Loss	4 years	Weight loss after laparoscopic banded sleeve gastrectomy during the follow-up

Secondary Outcome Measures

Name	Time	Method
Post-operative complications	4 years	Complications occurred after laparoscopic banded sleeve gastrectomy during the follow-up

Trial Locations

Locations (1)

Michela Campanelli; 🇮🇹 Rome, RM, Italy