Surplus Skin After Massive Weight LossNCT01551862
Complications in Lower Body Lifts
An observational study of Surplus Skin After Massive Weight Loss, run by Medical University of Vienna at 1 site in Austria.
Trial summary
A prospective study on 50 consecutive patients who are going to have a lower body lift procedure is performed. Measures include comorbidities and complications. Risk factors assessed including patient age, gender, highest lifetime body mass index (BMI) (BMI max), current BMI, excess weight loss (EWL), type of weight… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Surplus Skin After Massive Weight Loss
- What is being tested?
- body contouring surgery of back, abdomen and thighs
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2007to Sep 2011
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients which are referred to Department of Plastic Surgery for body contouring surgery
Who may be able to join
- after massive weight loss
- age > 18 years and < 65 years
- excess weight loss > 66%
- current body mass index < 35
- stable weight after weight loss for at least 12 months
Who cannot join
- insulin dependent diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Dept. of Plastic Surgery
Vienna, 1090
About this study
Official title: Prospective Study on Complications Following a Lower Body Lift After Massive Weight Loss
A prospective study on 50 consecutive patients who are going to have a lower body lift procedure is performed. Measures include comorbidities and complications. Risk factors assessed including patient age, gender, highest lifetime body mass index (BMI) (BMI max), current BMI, excess weight loss (EWL), type of weight loss and nicotine consumption.
- Conditions
- Surplus Skin After Massive Weight Loss
- Being tested
- body contouring surgery of back, abdomen and thighs
- Keywords
- lower body lift, body contouring surgery, massive weight loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body contouring surgery of back, abdomen and thighsProcedure or surgery
simultaneous body contouring surgery of back, abdomen and thighs
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJan 2007
- Primary completionMar 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surplus Skin After Massive Weight LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hugo B. Kitzinger, Medical University of Vienna
- Investigators
- Hugo B Kitzinger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551862
- Sponsor's protocol ID
- PlastSurg01
- Status last verified
- Mar 2012
- First submitted
- 6 Mar 2012
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kitzinger HB, Cakl T, Wenger R, Hacker S, Aszmann OC, Karle B. Prospective study on complications following a lower body lift after massive weight loss. J Plast Reconstr Aesthet Surg. 2013 Feb;66(2):231-8. doi: 10.1016/j.bjps.2012.09.006. Epub 2012 Oct 4.
PubMed 23040202
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Complications Following a Lower Body Lift After Massive Weight Loss
- ClinicalTrials.gov ID
- NCT01551862
- Acronym / sponsor ID
- PlastSurg01
- Conditions
- Surplus Skin After Massive Weight Loss
- Keywords
- lower body lift, body contouring surgery, massive weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Mar 2012 (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.
A prospective study on 50 consecutive patients who are going to have a lower body lift procedure is performed. Measures include comorbidities and complications. Risk factors assessed including patient age, gender, highest lifetime body mass index (BMI) (BMI max), current BMI, excess weight loss (EWL), type of weight loss and nicotine consumption.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients which are referred to Department of Plastic Surgery for body contouring surgery
Key inclusion criteria (5 listed)
- after massive weight loss
- age > 18 years and < 65 years
- excess weight loss > 66%
- current body mass index < 35
- stable weight after weight loss for at least 12 months
Key exclusion criteria (1 listed)
- insulin dependent diabetes mellitus
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 |
|---|---|---|
| body contouring surgery of back, abdomen and thighssimultaneous body contouring surgery of back, abdomen and thighs | Procedure or surgery | – |
Primary outcome
Complications
Time frame: 6 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 13 Mar 2012.
- Derived from this study: PubMed 23040202Kitzinger HB, Cakl T, Wenger R, Hacker S, Aszmann OC, Karle B. Prospective study on complications following a lower body lift after massive weight loss. J Plast Reconstr Aesthet Surg. 2013 Feb;66(2):231-8. doi: 10.1016/j.bjps.2012.09.006. Epub 2012 Oct 4.
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.
Hugo B Kitzinger, MD principal investigator
Medical University of Vienna
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 Surplus Skin After Massive Weight Loss, 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 5 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 13 Mar 2012. 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?
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?
Complications (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01551862, which also lists 1 linked publication.
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 13 Mar 2012.