Clinical Trial Between Laparoscopic Gastric Bypass and La... | NCT01639677

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

NCT01639677

Sponsor

Göteborg University

Status

Completed

Last Update Posted

Jul 13, 2012Estimated

Enrollment

100Actual

Phase

Phase 4

Conditions

Morbid Obesity

Interventions

Laparoscopic gastric bypass
Laparoscopic VBG

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2000

Primary Completion Date

Apr 2001Actual

Completion Date

Aug 2010Actual

First Submitted Date

Sep 22, 2011

First Submission Date that Met QC Criteria

Jul 10, 2012

First Posted Date

Jul 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2012

Last Update Posted Date

Jul 13, 2012Estimated

Name	Class
Imperial College London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparoscopic gastric bypass	Experimental		Procedure: Laparoscopic gastric bypass
Laparoscopic VBG	Active Comparator	Laparoscopic vertical banded gastroplasty	Procedure: Laparoscopic VBG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic gastric bypass	Procedure	Laparoscopic gastric bypass surgery	Laparoscopic gastric bypass

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight loss		1, 2, 5 and 10 years after surgery

Secondary Outcomes

Measure	Description	Time Frame
Body composition		1, 2, 5 and 10 years after surgery
Eating pattern		1, 2, 5 and 10 years after surgery
Energy expenditure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 35-50 kg/m2
20-60 y

Exclusion Criteria:

Severe co-morbidity
Unmotivated to long term follow up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Torsten Olbers, MD, PhD	GöteborgU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery		Gothenburg	Gothenburg	4145	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D009765	Obesity
D015431	Weight Loss

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided