Morbid ObesityNCT00840736
LAGB Versus VBG: 7-Year Results
A study testing Laparoscopic adjustable gastric banding and vertical banded gastroplasty in people with Morbid Obesity and Bariatric Surgery, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The study aims to investigate the long term results of a randomized clinical single-centre trial comparing two standard operative techniques in bariatric surgery; laparoscopic adjustable gastric banding and vertical banded gastroplasty. Read more about this study
- Who is it for?
- Ages 19 to 59 years
- Conditions the study is for
- Morbid Obesity, Bariatric Surgery, Vertical Banded Gastroplasty
- What is being tested?
- Laparoscopic adjustable gastric banding and vertical banded gastroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2007to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI of > 40 kg/m2 or > 35 kg/m2 with obesity-related comorbidities
- Failure to achieve sustainable weight loss with proven conservative measures
Who cannot join
- severe psychiatric and / or eating disorders
- unable to keep to a prescribed postoperative diet
- < 18 or > 60 years
- not eligible to bariatric surgery according to a member of the multidisciplinary team (psychologist, dietician, nurse practitioner, general practitioner and surgeon)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
About this study
Official title: Laparoscopic Adjustable Gastric Banding Versus Open Vertical Banded Gastroplasty: 7-Year Results of a Prospective Randomized Trial
The study aims to investigate the long term results of a randomized clinical single-centre trial comparing two standard operative techniques in bariatric surgery; laparoscopic adjustable gastric banding and vertical banded gastroplasty.
Read the detailed description
One hundred morbidly obese patients were included in the study. Randomization between the two operative techniques was performed using a computer model. Fifty patients were included in both groups. Weight loss, obesity-related comorbidity, long term complications, re-operations and conversions were all prospectively investigated for a mean period of 84 months.
- Conditions
- Morbid Obesity, Bariatric Surgery, Vertical Banded Gastroplasty, Laparoscopic Adjustable Gastric Banding, Long Term Results
- Being tested
- Laparoscopic adjustable gastric banding, vertical banded gastroplasty
- Keywords
- VBG, LAGB, long term results, Weight loss, Complications, Reoperations, Conversion
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic adjustable gastric bandingProcedure or surgery
Also called LAGB, AGB, LB, lap-band, SAGB
Laparoscopic adjustable gastric banding
vertical banded gastroplastyProcedure or surgery
Also called VBG, Mason, gastroplasty
vertical banded gastroplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Laparoscopic adjustable gastric banding Receives: Procedure: Laparoscopic adjustable gastric banding |
| 2 | Active comparator | vertical banded gastroplasty Receives: Procedure: vertical banded gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 84 months
Secondary outcomes (4)
co-morbidity
Measured: 84 months
complications
Measured: 84 months
reoperations / revisions / conversions
Measured: 84 months
Quality of life
Measured: 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jan Willem M Greve, Md PhD, Study director, Atrium Medical Centre ParkstadRuben Schouten, MD, Principal investigator, Atrium Medical Centre Parkstad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840736
- Sponsor's protocol ID
- LAGBvsVBG7y
- Status last verified
- Feb 2009
- First submitted
- 9 Feb 2009
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Adjustable Gastric Banding Versus Open Vertical Banded Gastroplasty: 7-Year Results of a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00840736
- Acronym / sponsor ID
- LAGBvsVBG7y
- Conditions
- Morbid Obesity, Bariatric Surgery, Vertical Banded Gastroplasty, Laparoscopic Adjustable Gastric Banding, Long Term Results
- Keywords
- VBG, LAGB, long term results, Weight loss, Complications, Reoperations, Conversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the long term results of a randomized clinical single-centre trial comparing two standard operative techniques in bariatric surgery; laparoscopic adjustable gastric banding and vertical banded gastroplasty.
Detailed description
One hundred morbidly obese patients were included in the study. Randomization between the two operative techniques was performed using a computer model. Fifty patients were included in both groups. Weight loss, obesity-related comorbidity, long term complications, re-operations and conversions were all prospectively investigated for a mean period of 84 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Laparoscopic adjustable gastric bandingLaparoscopic adjustable gastric banding |
| 2 | Active comparator | Procedure: vertical banded gastroplastyvertical banded gastroplasty |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI of > 40 kg/m2 or > 35 kg/m2 with obesity-related comorbidities
- Failure to achieve sustainable weight loss with proven conservative measures
Key exclusion criteria (4 listed)
- severe psychiatric and / or eating disorders
- unable to keep to a prescribed postoperative diet
- < 18 or > 60 years
- not eligible to bariatric surgery according to a member of the multidisciplinary team (psychologist, dietician, nurse practitioner, general practitioner and surgeon)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic adjustable gastric bandingAlso: LAGB, AGB, LB, lap-band, SAGBLaparoscopic adjustable gastric banding | Procedure or surgery | 1 |
| vertical banded gastroplastyAlso: VBG, Mason, gastroplastyvertical banded gastroplasty | Procedure or surgery | 2 |
Primary outcome
weight loss
Time frame: 84 months
4 secondary outcomes
co-morbidity
Time frame: 84 months
complications
Time frame: 84 months
reoperations / revisions / conversions
Time frame: 84 months
Quality of life
Time frame: 84 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2009.
Related trials for Morbid Obesity
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
Enrolling by invitation
Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach
Obesity, Morbid, Metabolic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Willem M Greve, Md PhD study director
Atrium Medical Centre Parkstad
Ruben Schouten, MD principal investigator
Atrium Medical Centre Parkstad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic adjustable gastric banding and vertical banded gastroplasty in people with Morbid Obesity and Bariatric Surgery, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2009.