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

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ClinicalTrials.gov Identifier: NCT01639677
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : July 13, 2012
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Torsten Olbers, Göteborg University

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Laparoscopic gastric bypass Procedure: Laparoscopic VBG Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity
Study Start Date : April 2000
Actual Primary Completion Date : April 2001
Actual Study Completion Date : August 2010

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




Primary Outcome Measures :
  1. Weight loss [ Time Frame: 1, 2, 5 and 10 years after surgery ]

Secondary Outcome Measures :
  1. Body composition [ Time Frame: 1, 2, 5 and 10 years after surgery ]
  2. Eating pattern [ Time Frame: 1, 2, 5 and 10 years after surgery ]
  3. Energy expenditure [ Time Frame: 1, 2, 5 and 10 years after surgery ]
  4. Gut hormonal response [ Time Frame: 4 and 10 years after surgery ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI 35-50 kg/m2
  • 20-60 y

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639677


Locations
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Sweden
Department of Surgery
Gothenburg, Sweden, 4145
Sponsors and Collaborators
Göteborg University
Imperial College London
Investigators
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Principal Investigator: Torsten Olbers, MD, PhD GöteborgU

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Responsible Party: Torsten Olbers, MD, PhD, Göteborg University
ClinicalTrials.gov Identifier: NCT01639677     History of Changes
Other Study ID Numbers: LOK-2
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012
Keywords provided by Torsten Olbers, Göteborg University:
Obesity
weight loss
surgery
gastric bypass
VBG
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms