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Clinical Trials/NCT04354532
NCT04354532CompletedNot Applicable

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

University of Rome Tor Vergata1 site in 1 country209 target enrollmentStarted: February 1, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
209
Locations
1
Primary Endpoint
% Excess Weight Loss
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Severe Obesity with BMI > 35 kg/m2

Exclusion Criteria

  • •Alcoholism
  • •Drug addiction
  • •Psychiatric Disease

Outcomes

Primary Outcomes

% Excess Weight Loss

Time Frame: 4 years

Weight loss after laparoscopic banded sleeve gastrectomy during the follow-up

Secondary Outcomes

  • Post-operative complications(4 years)

Investigators

Sponsor
University of Rome Tor Vergata
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paolo Gentileschi

Head of Bariatric Unit

University of Rome Tor Vergata

Study Sites (1)

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