Clinical Trials Directory

Trials / Completed

CompletedNCT04354532

Laparoscopic Banded Sleeve Gastrectomy

Laparoscopic Banded Sleeve Gastrectomy: Single-Centre Experience With A 4-Year Follow-Up

Status
Completed
Phase
Study type
Observational
Enrollment
209 (actual)
Sponsor
University of Rome Tor Vergata · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopic Banded Sleeve GastrectomyThe investigators performed Laparoscopic Sleeve Gastrectomy adding a MiniMizer Ring (Bariatric Solutions), a radiopaque silicone ring with four closing positions. The ring has a blue colour and for this reason it can easily be found back in revision surgery. The pulling lid is left in place with all closing positions in order to be adjusted postoperatively without having to place a new ring. The ring is slightly elastic and the fixation loops provide an anchorpoint to fix the ring in place which prevents it from slipping

Timeline

Start date
2014-02-01
Primary completion
2020-01-01
Completion
2020-02-01
First posted
2020-04-21
Last updated
2020-04-21

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04354532. Inclusion in this directory is not an endorsement.