Complications in Lower Body Lifts | NCT01551862

Studies
Complications in Lower Body Lifts

NCT01551862

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Mar 13, 2012Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Surplus Skin After Massive Weight Loss

Interventions

body contouring surgery of back, abdomen and thighs

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Mar 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Mar 6, 2012

First Submission Date that Met QC Criteria

Mar 12, 2012

First Posted Date

Mar 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2012

Last Update Posted Date

Mar 13, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Hugo B. Kitzinger, Principal investigator, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 loss and nicotine consumption.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
body contouring surgery of back, abdomen and thighs	Procedure	simultaneous body contouring surgery of back, abdomen and thighs

Measure	Description	Time Frame
Complications		6 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Patients which are referred to Department of Plastic Surgery for body contouring surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugo B Kitzinger, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna, Dept. of Plastic Surgery		Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23040202	Derived	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.