Effects of Body Contouring Surgery in Obese Patients

• Conditions: Validation Study; Quality of Life

• Registration Number: NCT02532751
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-23
• Study First Posted: 2015-08-26
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-22
• Study Start: 2018-04
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validity of the Finnish version of the BODY-Q questionnaire	6 months	The psychometric properties of the BODY-Q patient-reported outcome measure are measured
Health-related quality of life after body contouring surgery in obese patients	0.5 to 3 years	Health-related quality of life is assessed with a questionnaire
Depression after body contouring surgery in obese patients	0.5 to 3 years	Depression is assessed with a questionnaire
Body image after body contouring surgery in obese patients	0.5 to 3 years	Body image is assessed with a questionnaire

Secondary Outcome Measures

Name	Time	Method
The 15-Dimensions health-related quality of life instrument	0.5 to 3 years	Assessment of health-related quality of life
The BODY-Q questionnaire	0.5 to 3 years	Assessment of health-related quality of life and body image
The Raitasalo Beck Depression Index questionnaire	0.5 to 3 years	Assessment of depression

Trial Locations

Locations (2)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Uusimaa, Finland

Jorvi Central Hospital; 🇫🇮 Espoo, Uusimaa, Finland