Quality of Life and Body Image in Women Underwent Thighplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ana Carolina Bim Tedesco, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01453231
First received: October 13, 2011
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Obesity
Procedure: thighplasty
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quality of Life and Body Image in Women Underwent Thighplasty

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • questionnaire about quality of life and body image [ Time Frame: during 6 months ] [ Designated as safety issue: Yes ]
    The Questionnaires are apply three times, each 3 months, and until 6 months.


Enrollment: 30
Study Start Date: March 2009
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No surgery
Experimental: thighplasty Procedure: thighplasty
Plastic surgery of thigh

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.

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453231

Locations
Brazil
University Federal of Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Ana Tedesco, Master Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Ana Carolina Bim Tedesco, Physical Therapist, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01453231     History of Changes
Other Study ID Numbers: ATedesco
Study First Received: October 13, 2011
Last Updated: May 27, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
bariatric surgery
plastic surgery
thigh
obesity
body image
quality of life

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014