Quality of Life and Body Image in Women Underwent Thighplasty

May 27, 2013 updated by: Ana Carolina Bim Tedesco, Federal University of São Paulo
Obesity is a chronic disease now considered a major public health concern in the global context, as it causes or exacerbates many diseases limitations in providing quality of life and higher treatment costs. The increase in the number of patients undergoing bariatric surgery and the excess skin and subcutaneous tissue adjacent to slimming collaborate in the search for growth by plastic surgery. Currently several techniques of thighplasty has been submitted but no studies were found that evaluated the characteristic clinical and emotional resulting from this procedure. This study has as a goal to evaluate the body image and quality of life in women submitted to thighplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients have been evaluated for two different questionnaires, the Body Dysmorphic Disorder Examination (BDDE) and Impact Weight on Quality of Life - Lite (IWQoL-Lite). The sample consists of 50 patients with the desire to undergo to the thighplasty. However 25 are from study group and 25 control group. Just the study group was undergoing plastic surgery. The questionnaires have applied by signing the consent form, after 3 and 6 months both groups. This study is a clinical trial, control, primary, longitudinal, no random, analytical, held in a single center.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • University Federal of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • abdominoplasty previous
  • control of systemic disease
  • Adults at the age of 35 and 50 years old
  • had reached massive weight loss less by bariatric surgery or similar than 30 kg/m2 for a minimum of 12 months or more.
  • gender: female
  • For control group: it supposed to be on the waiting list for thighplasty
  • For study group:they are supposed to be scheduled for thighplasty

Exclusion Criteria:

  • illiterate
  • pregnant women and/or women who have been nursing for one year or less
  • non-controled of systemic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No surgery
Experimental: thighplasty
Procedure: thighplasty
Plastic surgery of thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
questionnaire about quality of life and body image
Time Frame: during 6 months
The Questionnaires are apply three times, each 3 months, and until 6 months.
during 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Ana Tedesco, Master, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

October 14, 2011

First Posted (Estimate)

October 17, 2011

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 27, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ATedesco

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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