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

January 11, 2020 updated by: Stefano D'Ugo, University of Rome Tor Vergata

Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results From a Prospective Randomized Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00133
        • Tor Vergata University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic banded sleeve gastrectomy
Group undergoing banded sleeve
Procedure: sleeve gastrectomy
Comparison of banded and not-banded sleeve gastrectomy
Active Comparator: Laparoscopic sleeve gastrectomy
Group undergoing standard sleeve
Procedure: sleeve gastrectomy
Comparison of banded and not-banded sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: from surgery to 4 years follow up
comparison of weight loss between the two procedures
from surgery to 4 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: from surgery to 4 years follow up
Short and mid-term complications
from surgery to 4 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Investigators

  • Principal Investigator: Stefano D'Ugo, MD PhD, Tor Vergata University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 11, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 11, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Banded_Sleeve

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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