Quality of Life and Body Image in Women Underwent Thighplasty

NCT ID: NCT01453231

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-01-31

Brief 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.

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

No surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

thighplasty

Group Type: EXPERIMENTAL

thighplasty

Intervention Type: PROCEDURE

Plastic surgery of thigh

Interventions

thighplasty

Plastic surgery of thigh

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ana Carolina Bim Tedesco

Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Tedesco, Master

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

University Federal of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

ATedesco

Identifier Type: -

Identifier Source: org_study_id