Surplus Skin After Massive Weight Loss Clinical Trial
Official title:
Prospective Study on Complications Following a Lower Body Lift After Massive Weight Loss
| Verified date | March 2012 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | September 2011 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 64 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - insulin dependent diabetes mellitus |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna, Dept. of Plastic Surgery | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complications | 6 months | No |