Effect of Revisional Surgery for Failed Gastric BandingNCT01771744
Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis
An observational study of Effect of Revisional Surgery for Failed Gastric Banding, run by University Hospital, Basel, Switzerland.
Trial summary
This study compared revisional malabsorptive laparoscopic very very long limb gastric bypass (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric banding. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Effect of Revisional Surgery for Failed Gastric Banding
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Jan 2013
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: morbidly obese patients
Who may be able to join
- Primary Gastric Bypass according to SMOB (Swiss group for the study of morbid obesity) Guidelines
- Revisional Gastric Bypass after failed Gastric Banding
Who cannot join
- According to SMOB Criteria
About this study
This study compared revisional malabsorptive laparoscopic very very long limb gastric bypass (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric banding.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Morbidly obese patients | 48 morbidly obese patients with revisional gastric bypass | |
| 48 morbidly obese patients | with primary gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 2 years
Secondary outcomes (1)
Complication rate
Measured: early (30 days) and late (> 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2000
- Primary completionDec 2010
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Revisional Surgery for Failed Gastric BandingStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Delko, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771744
- Sponsor's protocol ID
- Revisional Limmi 1
- Status last verified
- Jan 2013
- First submitted
- 16 Jan 2013
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis
- ClinicalTrials.gov ID
- NCT01771744
- Acronym / sponsor ID
- Revisional Limmi 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 Jan 2013 (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 study compared revisional malabsorptive laparoscopic very very long limb gastric bypass (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric banding.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morbidly obese patients | – | –48 morbidly obese patients with revisional gastric bypass |
| 48 morbidly obese patients | – | –with primary gastric bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- morbidly obese patients
Key inclusion criteria (2 listed)
- Primary Gastric Bypass according to SMOB (Swiss group for the study of morbid obesity) Guidelines
- Revisional Gastric Bypass after failed Gastric Banding
Key exclusion criteria (1 listed)
- According to SMOB Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
weight loss
Time frame: 2 years
1 secondary outcome
Complication rate
Time frame: early (30 days) and late (> 30 days)
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 18 Jan 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Effect of Revisional Surgery for Failed Gastric Banding, run by University Hospital, Basel, Switzerland.
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 1 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 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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: 2 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 18 Jan 2013.