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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Laparoscopic gastric bypass
Laparoscopic VBG
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Obesity, weight loss, surgery, gastric bypass, VBG

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI 35-50 kg/m2
  • 20-60 y

Exclusion Criteria:

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

Sites / Locations

  • Department of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic gastric bypass

Laparoscopic VBG

Arm Description

Laparoscopic vertical banded gastroplasty

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Body composition
Eating pattern
Energy expenditure
Gut hormonal response

Full Information

First Posted
September 22, 2011
Last Updated
July 10, 2012
Sponsor
Göteborg University
Collaborators
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT01639677
Brief Title
Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity
Acronym
LOK
Official Title
Randomized Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
April 2001 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Göteborg University
Collaborators
Imperial College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Obesity, weight loss, surgery, gastric bypass, VBG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic gastric bypass
Arm Type
Experimental
Arm Title
Laparoscopic VBG
Arm Type
Active Comparator
Arm Description
Laparoscopic vertical banded gastroplasty
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastric bypass
Intervention Description
Laparoscopic gastric bypass surgery
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic VBG
Intervention Description
Laparoscopic vertical banded gastroplasty
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
1, 2, 5 and 10 years after surgery
Secondary Outcome Measure Information:
Title
Body composition
Time Frame
1, 2, 5 and 10 years after surgery
Title
Eating pattern
Time Frame
1, 2, 5 and 10 years after surgery
Title
Energy expenditure
Time Frame
1, 2, 5 and 10 years after surgery
Title
Gut hormonal response
Time Frame
4 and 10 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI 35-50 kg/m2 20-60 y Exclusion Criteria: Severe co-morbidity Unmotivated to long term follow up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torsten Olbers, MD, PhD
Organizational Affiliation
GöteborgU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery
City
Gothenburg
ZIP/Postal Code
4145
Country
Sweden

12. IPD Sharing Statement

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

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