ObesityROI-LGBPNCT01986816
Return on Investment on Lap Gastric Bypass Regarding Quality of Life
An observational study of Obesity, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the cost of treatment and adverse efffects therof corresponds to quality of life improvements and expected wheightloss. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to Dec 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Populutaion af morbid obese patients with BMI of 35 or more eligible for bariatric surgery
Who may be able to join
- BMI > 35
- age 18-60 years
Who cannot join
- Prior bariatric surgery
- Prior gastric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lap Gastric Bypass and Its Impact on Wheightloss, QoL and Economic Cost
The purpose of this study is to investigate the cost of treatment and adverse efffects therof corresponds to quality of life improvements and expected wheightloss.
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Laparoscopic gastric bypass, Quality of life, QALY
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant wheigtloss
Measured: 1 year
Secondary outcomes (1)
Quality of life improvement
Measured: 3 months and 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Investigaotr no longer at LU.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Landstinget i Kalmar Län
- Responsible party
- Principal investigator, Johan Berggren, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986816
- Sponsor's protocol ID
- ROI-LGBP
- Acronym
- ROI-LGBP
- Status last verified
- Feb 2019
- First submitted
- 11 Nov 2013
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lap Gastric Bypass and Its Impact on Wheightloss, QoL and Economic Cost
- ClinicalTrials.gov ID
- NCT01986816
- Acronym / sponsor ID
- ROI-LGBP / ROI-LGBP
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Laparoscopic gastric bypass, Quality of life, QALY
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigaotr no longer at LU.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Landstinget i Kalmar Län
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Nov 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.
The purpose of this study is to investigate the cost of treatment and adverse efffects therof corresponds to quality of life improvements and expected wheightloss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Populutaion af morbid obese patients with BMI of 35 or more eligible for bariatric surgery
Key inclusion criteria (2 listed)
- BMI > 35
- age 18-60 years
Key exclusion criteria (2 listed)
- Prior bariatric surgery
- Prior gastric surgery
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
Significant wheigtloss
Time frame: 1 year
1 secondary outcome
Quality of life improvement
Time frame: 3 months and 12 months post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Lund University at 1 site in Sweden.
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 2 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: withdrawn, as of the sponsor's last update on 15 Feb 2019. 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 Sweden. 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 was withdrawn before enrolling participants, so there are no results.
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?
Significant wheigtloss (time frame: 1 year). 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 15 Feb 2019.