Validation StudyNCT02532751
Effects of Body Contouring Surgery in Obese Patients
An observational study of Validation Study and Quality of Life, run by Helsinki University Central Hospital at 2 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Validation Study, Quality of Life
- How many people
- 100 participants
- Where
- 2 sitesFinland
- Study dates
- Apr 2018to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients who underwent body contour surgery
Who may be able to join
- Body contouring surgery due to:
- massive weight loss B) Postbariatric weight loss
- Patient age over 18 years
Who cannot join
- Patient age under 18 years
- No body contouring surgery
- Surgical intervention performed in another hospital than Helsinki and Uusimaa Hospital District
- No obesity
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Jorvi Central Hospital
Espoo, Uusimaa
Tiina Jahkola, MD, PhD
Pauliina Homsy, MD, PhD (Cantab)
Helsinki University Central Hospital
Helsinki, Uusimaa, 00029
Jussi P Repo, MD, +358443593100, mrjussirepo@gmail.com
Jussi P Repo, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Validation Study, Quality of Life
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the Finnish version of the BODY-Q questionnaire
The psychometric properties of the BODY-Q patient-reported outcome measure are measured
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
Measured: 0.5 to 3 years
Depression after body contouring surgery in obese patients
Depression is assessed with a questionnaire
Measured: 0.5 to 3 years
Body image after body contouring surgery in obese patients
Body image is assessed with a questionnaire
Measured: 0.5 to 3 years
Secondary outcomes (3)
The 15-Dimensions health-related quality of life instrument
Assessment of health-related quality of life
Measured: 0.5 to 3 years
The BODY-Q questionnaire
Assessment of health-related quality of life and body image
Measured: 0.5 to 3 years
The Raitasalo Beck Depression Index questionnaire
Assessment of depression
Measured: 0.5 to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startApr 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation StudyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jussi Repo, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532751
- Sponsor's protocol ID
- 204/13/03/02/15/1
- Status last verified
- Feb 2018
- First submitted
- 17 Aug 2015
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Body Contouring Surgery in Obese Patients: a Prospective Study
- ClinicalTrials.gov ID
- NCT02532751
- Acronym / sponsor ID
- 204/13/03/02/15/1
- Conditions
- Validation Study, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients who underwent body contour surgery
Key inclusion criteria (3 listed)
- Body contouring surgery due to:
- massive weight loss B) Postbariatric weight loss
- Patient age over 18 years
Key exclusion criteria (4 listed)
- Patient age under 18 years
- No body contouring surgery
- Surgical intervention performed in another hospital than Helsinki and Uusimaa Hospital District
- No obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validity of the Finnish version of the BODY-Q questionnaire
Time frame: 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
Time frame: 0.5 to 3 years
Health-related quality of life is assessed with a questionnaire
Depression after body contouring surgery in obese patients
Time frame: 0.5 to 3 years
Depression is assessed with a questionnaire
Body image after body contouring surgery in obese patients
Time frame: 0.5 to 3 years
Body image is assessed with a questionnaire
3 secondary outcomes
The 15-Dimensions health-related quality of life instrument
Time frame: 0.5 to 3 years
The BODY-Q questionnaire
Time frame: 0.5 to 3 years
The Raitasalo Beck Depression Index questionnaire
Time frame: 0.5 to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation Study and Quality of Life, run by Helsinki University Central Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jussi P Repo, MD (+358443593100, mrjussirepo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the Finnish version of the BODY-Q questionnaire (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.