NCT01639677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
9.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

September 22, 2011

Last Update Submit

July 10, 2012

Conditions

Morbid Obesity

Keywords

Obesityweight losssurgerygastric bypassVBG

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    1, 2, 5 and 10 years after surgery

Secondary Outcomes (4)

  • Body composition

    1, 2, 5 and 10 years after surgery

  • Eating pattern

    1, 2, 5 and 10 years after surgery

  • Energy expenditure

    1, 2, 5 and 10 years after surgery

  • Gut hormonal response

    4 and 10 years after surgery

Study Arms (2)

Laparoscopic gastric bypass

EXPERIMENTAL
Procedure: Laparoscopic gastric bypass

Laparoscopic VBG

ACTIVE COMPARATOR

Laparoscopic vertical banded gastroplasty

Procedure: Laparoscopic VBG

Interventions

Laparoscopic gastric bypassPROCEDURE

Laparoscopic gastric bypass surgery

Laparoscopic gastric bypass
Laparoscopic VBGPROCEDURE

Laparoscopic vertical banded gastroplasty

Laparoscopic VBG

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 35-50 kg/m2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery

Gothenburg, Gothenburg, 4145, Sweden

Location

MeSH Terms

Conditions

Obesity, MorbidObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Torsten Olbers, MD, PhD

    GöteborgU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 22, 2011

First Posted

July 13, 2012

Study Start

April 1, 2000

Primary Completion

April 1, 2001

Study Completion

August 1, 2010

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

SE(1)