NCT01453231

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_1 obesity

Geographic Reach
1 country

1 active site

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

March 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

3.8 years

First QC Date

October 13, 2011

Last Update Submit

May 27, 2013

Conditions

Keywords

bariatric surgeryplastic surgerythighobesitybody imagequality of life

Outcome Measures

Primary Outcomes (1)

  • questionnaire about quality of life and body image

    The Questionnaires are apply three times, each 3 months, and until 6 months.

    during 6 months

Study Arms (2)

Control

NO INTERVENTION

No surgery

thighplasty

EXPERIMENTAL
Procedure: thighplasty

Interventions

thighplastyPROCEDURE

Plastic surgery of thigh

thighplasty

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Federal of Sao Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ana Tedesco, Master

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 17, 2011

Study Start

March 1, 2009

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations