The Effects of Body Contouring: Abdominoplasty and Liposu... | NCT02151799

Studies
The Effects of Body Contouring: Abdominoplasty and Liposuction

NCT02151799

Sponsor

Tampere University Hospital

Status

Completed

Last Update Posted

Nov 4, 2015Estimated

Enrollment

143Actual

Phase

Phase 4

Conditions

Subcutaneous Abdominal Fat
Abdominal Skin Elasticity
Rectus Muscle Diastasis
Unpleasant Body Contour

Interventions

Abdominoplasty and liposuction

Countries

Not provided

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

Nov 2015

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 2010

Primary Completion Date

Feb 2014Actual

Completion Date

Nov 2015Actual

First Submitted Date

May 28, 2014

First Submission Date that Met QC Criteria

May 28, 2014

First Posted Date

May 30, 2014Estimated

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

Nov 3, 2015

Last Update Posted Date

Nov 4, 2015Estimated

Description Module

Brief Summary

The data regarding the effects of aesthetic body contouring is insufficient. Poor results may related to preoperative psychological distress. Studies regarding eating disorder symptoms are lacking. Therefore studies using standardized and validated are needed. We decided to prospectively study quality of life, psychological distress, and eating disorder symptoms in body contouring (abdominoplasty or liposuction) patient populations. Used questionnaires are 15D quality of life, Raitasalo's modification of the Beck Inventory, and the Eating Disorder Inventory. We hypothesize that aesthetic body contouring plastic surgery has notable quality of life effects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Body contouring surgery	Experimental		Procedure: Abdominoplasty and liposuction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Abdominoplasty and liposuction	Procedure		Body contouring surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life	15D quality of life questionnaire RBDI mood questionnaire Eating Disorder Inventory questionnaire	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients requesting body contouring surgery

Exclusion Criteria:

previous abdominal aesthetic surgery, simultaneous other aesthetic surgery at the same time

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25506426	Derived	Saariniemi KM, Salmi AM, Peltoniemi HH, Helle MH, Charpentier P, Kuokkanen HO. Abdominoplasty improves quality of life, psychological distress, and eating disorder symptoms: a prospective study. Plast Surg Int. 2014;2014:197232. doi: 10.1155/2014/197232. Epub 2014 Nov 24.

ID	Term
D061645	Abdominoplasty
D015187	Lipectomy

ID	Term
D003357	Cosmetic Techniques
D013812	Therapeutics
D019651	Plastic Surgery Procedures
D013514	Surgical Procedures, Operative