Effects of Body Contouring Surgery in Obese Patients

Quality of Life Clinical Trial

Official title:

Effects of Body Contouring Surgery in Obese Patients: a Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02532751
• Other study ID #: 204/13/03/02/15/1
• Status: Not yet recruiting
• Phase: N/A
• First received: August 17, 2015
• Last updated: February 21, 2018
• Start date: April 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2018
• Source: Helsinki University Central Hospital
• Contact: Jussi P Repo, MD
• Phone: +358443593100
• Email: mrjussirepo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is twofold; 1) to assess the psychometric properties of the Finnish version of the BODY-Q questionnaire, 2) to assess the effects of body contouring surgery using patient-reported outcome measures.

Description:

The BODY-Q is translated into Finnish through forward and backward translation and a committee review. The preliminary version is pilot tested with 20 participants undergoing body contouring surgery.

The study is of longitudinal design gathering data from participants undergoing body contouring surgery due to obesity. Data collection takes place in the Department of Plastic Surgery, Helsinki University Central Hospital, Helsinki, Finland. The participants fill in three patient-reported outcome measures.

The outcomes of the three patient-reported outcome measures are compared with each other and internal validity assessed. Test-retest reliability is assessed after two weeks from the first completion of the questionnaires. With validated questionnaires the effects of body contouring surgery is assessed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Body contouring surgery due to:

A) massive weight loss B) Postbariatric weight loss

• Patient age over 18 years

Exclusion Criteria:

• Patient age under 18 years

• No body contouring surgery

• Surgical intervention performed in another hospital than Helsinki and Uusimaa Hospital District

• No obesity

Related Conditions & MeSH terms

• Quality of Life
• Validation Study

Locations

Country	Name	City	State
Finland	Jorvi Central Hospital	Espoo	Uusimaa
Finland	Helsinki University Central Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of the Finnish version of the BODY-Q questionnaire	The psychometric properties of the BODY-Q patient-reported outcome measure are measured	6 months
Primary	Health-related quality of life after body contouring surgery in obese patients	Health-related quality of life is assessed with a questionnaire	0.5 to 3 years
Primary	Depression after body contouring surgery in obese patients	Depression is assessed with a questionnaire	0.5 to 3 years
Primary	Body image after body contouring surgery in obese patients	Body image is assessed with a questionnaire	0.5 to 3 years
Secondary	The 15-Dimensions health-related quality of life instrument	Assessment of health-related quality of life	0.5 to 3 years
Secondary	The BODY-Q questionnaire	Assessment of health-related quality of life and body image	0.5 to 3 years
Secondary	The Raitasalo Beck Depression Index questionnaire	Assessment of depression	0.5 to 3 years