Quality of Life and Body Image in Women Underwent Thighplasty

Obesity Clinical Trial

Official title:

Quality of Life and Body Image in Women Underwent Thighplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453231
• Other study ID #: ATedesco
• Status: Completed
• Phase: Phase 1
• First received: October 13, 2011
• Last updated: May 27, 2013
• Start date: March 2009
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• thighplasty
Plastic surgery of thigh

Locations

Country	Name	City	State
Brazil	University Federal of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaire about quality of life and body image	The Questionnaires are apply three times, each 3 months, and until 6 months.	during 6 months	Yes