Morbid ObesityNCT01078181
Banded Versus Non-banded Roux-en-Y Gastric Bypass
A study testing gastric bypass in people with Morbid Obesity, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This is a prospective randomized Study comparing Weight loss, Esophageal Motility and Reflux in lap. Gastric Bypass vs. lap. Banded-Gastric Bypass using the A.M.I. Soft Gastric Bypass Band (B-Band. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2009to May 2014
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI > 40 or BMI > 35 + hypertension/diabetes mellitus
- pH metry and manometry preoperatively
Who cannot join
- formerly operations of the stomach
- formerly open abdominal surgery
- malignancy within the last 5 years
- formerly gastric banding
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Surgery
Vienna, 1090
Gerhard Prager, M.D., +43-1-40400 ext. 5621, gerhard.prager@meduniwien.ac.at
Felix B Langer, M.D., +43-1-40400 ext. 5621, felix.langer@meduniwien.ac.at
About this study
Official title: A Prospective Randomized Comparison on Weight Loss After Gastric Bypass and Banded Gastric Bypass Using the A.M.I B-Band (Soft Gastric Bypass Band)
This is a prospective randomized Study comparing Weight loss, Esophageal Motility and Reflux in lap. Gastric Bypass vs. lap. Banded-Gastric Bypass using the A.M.I. Soft Gastric Bypass Band (B-Band.
- Conditions
- Morbid Obesity
- Being tested
- gastric bypass
- Keywords
- gastric bypass, banded gastric bypass, weight loss, weight regain, bariatric surgery
- 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.
gastric bypassProcedure or surgery
Also called laparoscopic gastric bypass, laparoscopic banded gastric bypass
laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy
| Study group | Role | What they receive |
|---|---|---|
| banded gastric bypass | Active comparator | Banded gastric bypass (circular anastomosis 21mm) using the A.M.I. B-Band (Soft Gastric Bypass Band) Receives: Procedure: gastric bypass |
| non-banded gastric bypass | Active comparator | non-banded gastric bypass (circular anastomosis 21mm) Receives: Procedure: gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excessive Weight Loss
Measured: 3 years
Secondary outcomes (1)
pouch dilatation, band migration, reflux, esophageal motility
Pouch dilatation verified by double contrast upper GI series Band migrations verified by gastroscopy Reflux verifies by pH-metry and gastroscopy Esophageal motility measured by manomerty
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Prager, M.D., Principal investigator, Medical University of Vienna, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078181
- Sponsor's protocol ID
- MUW ADIP STUDY 15
- Other IDs
- Banded Bypass Study 15
- Status last verified
- Nov 2009
- First submitted
- 1 Mar 2010
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison on Weight Loss After Gastric Bypass and Banded Gastric Bypass Using the A.M.I B-Band (Soft Gastric Bypass Band)
- ClinicalTrials.gov ID
- NCT01078181
- Acronym / sponsor ID
- MUW ADIP STUDY 15
- Conditions
- Morbid Obesity
- Keywords
- gastric bypass, banded gastric bypass, weight loss, weight regain, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 2 Mar 2010 (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.
This is a prospective randomized Study comparing Weight loss, Esophageal Motility and Reflux in lap. Gastric Bypass vs. lap. Banded-Gastric Bypass using the A.M.I. Soft Gastric Bypass Band (B-Band.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| banded gastric bypass | Active comparator | Procedure: gastric bypassBanded gastric bypass (circular anastomosis 21mm) using the A.M.I. B-Band (Soft Gastric Bypass Band) |
| non-banded gastric bypass | Active comparator | Procedure: gastric bypassnon-banded gastric bypass (circular anastomosis 21mm) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI > 40 or BMI > 35 + hypertension/diabetes mellitus
- pH metry and manometry preoperatively
Key exclusion criteria (4 listed)
- formerly operations of the stomach
- formerly open abdominal surgery
- malignancy within the last 5 years
- formerly gastric banding
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 |
|---|---|---|
| gastric bypassAlso: laparoscopic gastric bypass, laparoscopic banded gastric bypasslaparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy | Procedure or surgery | banded gastric bypass, non-banded gastric bypass |
Primary outcome
Excessive Weight Loss
Time frame: 3 years
1 secondary outcome
pouch dilatation, band migration, reflux, esophageal motility
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2010.
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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.
Gerhard Prager, M.D. principal investigator
Medical University of Vienna, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastric bypass in people with Morbid Obesity, run by Medical University of Vienna at 1 site in Austria.
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: status not confirmed, as of the sponsor's last update on 24 Jun 2010. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Prager, M.D. (+43-1-40400 ext. 5621, gerhard.prager@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excessive Weight Loss (time frame: 3 years). 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 24 Jun 2010.