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

NCT ID: NCT01639677

Last Updated: 2012-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity

Keywords

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Obesity weight loss surgery gastric bypass VBG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic gastric bypass

Group Type EXPERIMENTAL

Laparoscopic gastric bypass

Intervention Type PROCEDURE

Laparoscopic gastric bypass surgery

Laparoscopic VBG

Laparoscopic vertical banded gastroplasty

Group Type ACTIVE_COMPARATOR

Laparoscopic VBG

Intervention Type PROCEDURE

Laparoscopic vertical banded gastroplasty

Interventions

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Laparoscopic gastric bypass

Laparoscopic gastric bypass surgery

Intervention Type PROCEDURE

Laparoscopic VBG

Laparoscopic vertical banded gastroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI 35-50 kg/m2
* 20-60 y

Exclusion Criteria

* Severe co-morbidity
* Unmotivated to long term follow up
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Torsten Olbers

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Torsten Olbers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

GöteborgU

Locations

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Department of Surgery

Gothenburg, Gothenburg, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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LOK-2

Identifier Type: -

Identifier Source: org_study_id