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

Morbid Obesity Clinical Trial

— LOK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639677
• Other study ID #: LOK-2
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2011
• Last updated: July 10, 2012
• Start date: April 2000
• Est. completion date: August 2010

Study information

• Verified date: July 2012
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2010
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI 35-50 kg/m2

• 20-60 y

Exclusion Criteria:

• Severe co-morbidity

• Unmotivated to long term follow up

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic gastric bypass
Laparoscopic gastric bypass surgery
• Laparoscopic VBG
Laparoscopic vertical banded gastroplasty

Locations

Country	Name	City	State
Sweden	Department of Surgery	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Imperial College London

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		1, 2, 5 and 10 years after surgery	No
Secondary	Body composition		1, 2, 5 and 10 years after surgery	No
Secondary	Eating pattern		1, 2, 5 and 10 years after surgery	No
Secondary	Energy expenditure		1, 2, 5 and 10 years after surgery	No
Secondary	Gut hormonal response		4 and 10 years after surgery	No