NCT02151799

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

4.1 years

First QC Date

May 28, 2014

Last Update Submit

November 3, 2015

Conditions

Subcutaneous Abdominal FatAbdominal Skin ElasticityRectus Muscle DiastasisUnpleasant Body Contour

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    15D quality of life questionnaire RBDI mood questionnaire Eating Disorder Inventory questionnaire

    6 months

Study Arms (1)

Body contouring surgery

EXPERIMENTAL
Procedure: Abdominoplasty and liposuction

Interventions

Abdominoplasty and liposuctionPROCEDURE
Body contouring surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients requesting body contouring surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25506426DERIVED

Related Links

MeSH Terms

Interventions

AbdominoplastyLipectomy

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsPlastic Surgery ProceduresSurgical Procedures, OperativeBariatric SurgeryBariatricsObesity Management

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

January 1, 2010

Primary Completion

February 1, 2014

Study Completion

November 1, 2015

Last Updated

November 4, 2015

Record last verified: 2015-11