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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02151799
Other study ID # R09166
Secondary ID
Status Completed
Phase Phase 4
First received May 28, 2014
Last updated November 3, 2015
Start date January 2010
Est. completion date November 2015

Study information

Verified date November 2015
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date November 2015
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- patients requesting body contouring surgery

Exclusion Criteria:

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Abdominoplasty and liposuction


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tampere University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life 15D quality of life questionnaire RBDI mood questionnaire Eating Disorder Inventory questionnaire 6 months No

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