Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity (LOK)

July 10, 2012 updated by: Torsten Olbers, Göteborg University

Randomized Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity

This is a randomized clinical trial assessing the outcome of two surgical strategies to treat severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is weight loss and weight loss maintenance but other factors as body composition, eating pattern, metabolic normalisation, energy expenditure will also be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

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

  • Sweden
      • Gothenburg, Sweden, 4145
        • Department of Surgery

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

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 35-50 kg/m2
  • 20-60 y

Exclusion Criteria:

  • Severe co-morbidity
  • Unmotivated to long term follow up

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laparoscopic gastric bypass
Procedure: Laparoscopic gastric bypass
Laparoscopic gastric bypass surgery
ACTIVE_COMPARATOR: Laparoscopic VBG
Laparoscopic vertical banded gastroplasty
Procedure: Laparoscopic VBG
Laparoscopic vertical banded gastroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 1, 2, 5 and 10 years after surgery
1, 2, 5 and 10 years after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: 1, 2, 5 and 10 years after surgery
1, 2, 5 and 10 years after surgery
Eating pattern
Time Frame: 1, 2, 5 and 10 years after surgery
1, 2, 5 and 10 years after surgery
Energy expenditure
Time Frame: 1, 2, 5 and 10 years after surgery
1, 2, 5 and 10 years after surgery
Gut hormonal response
Time Frame: 4 and 10 years after surgery
4 and 10 years after surgery

Collaborators and Investigators

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

Sponsor

Göteborg University

Collaborators

Imperial College London

Investigators

  • Principal Investigator: Torsten Olbers, MD, PhD, GöteborgU

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

April 1, 2000

Primary Completion (ACTUAL)

April 1, 2001

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

July 10, 2012

First Posted (ESTIMATE)

July 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOK-2

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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