Effects of Body Contouring Surgery in Obese Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Validation Study

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jussi P Repo, MD; Phone Number: +358443593100; Email: mrjussirepo@gmail.com
• Study Contact Backup: Name: Pentscho Popov, MD, PhD; Phone Number: +35894711; Email: pentscho.popov@hus.fi

Study Locations

• Finland
  • Uusimaa
    • Espoo, Uusimaa, Finland
      • Jorvi Central Hospital
      • Contact: Tiina Jahkola, MD, PhD
      • Contact: Pauliina Homsy, MD, PhD (Cantab)
    • Helsinki, Uusimaa, Finland, 00029
      • Helsinki University Central Hospital
      • Contact: Jussi P Repo, MD; Phone Number: +358443593100; Email: mrjussirepo@gmail.com
      • Principal Investigator: Jussi P Repo, MD
      • Principal Investigator: Pentscho Popov, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 patients who underwent body contour surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Depression after body contouring surgery in obese patients	Depression is assessed with a questionnaire	0.5 to 3 years
Body image after body contouring surgery in obese patients	Body image is assessed with a questionnaire	0.5 to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 23, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 204/13/03/02/15/1