Subcutaneous Abdominal FatPhase 4NCT02151799
The Effects of Body Contouring: Abdominoplasty and Liposuction
A Phase 4 study testing Abdominoplasty and liposuction in people with Subcutaneous Abdominal Fat and Abdominal Skin Elasticity, run by Tampere University Hospital.
Trial summary
The data regarding the effects of aesthetic body contouring is insufficient. Poor results may related to preoperative psychological distress. Studies regarding eating disorder symptoms are lacking. Therefore studies using standardized and validated are needed. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Subcutaneous Abdominal Fat, Abdominal Skin Elasticity, Rectus Muscle Diastasis
- What is being tested?
- Abdominoplasty and liposuction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Nov 2015
- Phase
- Phase 4
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients requesting body contouring surgery
Who cannot join
- previous abdominal aesthetic surgery, simultaneous other aesthetic surgery at the same time
About this study
Official title: Body Contouring - the Analysis of Non-invasive and Invasive Methods and Their Interventional Effects on Quality of Life
The data regarding the effects of aesthetic body contouring is insufficient. Poor results may related to preoperative psychological distress. Studies regarding eating disorder symptoms are lacking. Therefore studies using standardized and validated are needed. We decided to prospectively study quality of life, psychological distress, and eating disorder symptoms in body contouring (abdominoplasty or liposuction) patient populations. Used questionnaires are 15D quality of life, Raitasalo's modification of the Beck Inventory, and the Eating Disorder Inventory. We hypothesize that aesthetic body contouring plastic surgery has notable quality of life effects.
- Conditions
- Subcutaneous Abdominal Fat, Abdominal Skin Elasticity, Rectus Muscle Diastasis, Unpleasant Body Contour
- Being tested
- Abdominoplasty and liposuction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominoplasty and liposuctionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Body contouring surgery | Experimental | Not described Receives: Procedure: Abdominoplasty and liposuction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
15D quality of life questionnaire RBDI mood questionnaire Eating Disorder Inventory questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJan 2010
- Primary completionFeb 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subcutaneous Abdominal FatStudies of the same condition, open and under way.
- More trials run by Tampere University 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151799
- Sponsor's protocol ID
- R09166
- Status last verified
- Nov 2015
- First submitted
- 28 May 2014
- Last updated
- 4 Nov 2015
- Results posted
- No
Publications
Saariniemi KM, Salmi AM, Peltoniemi HH, Helle MH, Charpentier P, Kuokkanen HO. Abdominoplasty improves quality of life, psychological distress, and eating disorder symptoms: a prospective study. Plast Surg Int. 2014;2014:197232. doi: 10.1155/2014/197232. Epub 2014 Nov 24.
PubMed 25506426
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Contouring - the Analysis of Non-invasive and Invasive Methods and Their Interventional Effects on Quality of Life
- ClinicalTrials.gov ID
- NCT02151799
- Acronym / sponsor ID
- R09166
- Conditions
- Subcutaneous Abdominal Fat, Abdominal Skin Elasticity, Rectus Muscle Diastasis, Unpleasant Body Contour
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 May 2014 (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 data regarding the effects of aesthetic body contouring is insufficient. Poor results may related to preoperative psychological distress. Studies regarding eating disorder symptoms are lacking. Therefore studies using standardized and validated are needed. We decided to prospectively study quality of life, psychological distress, and eating disorder symptoms in body contouring (abdominoplasty or liposuction) patient populations. Used questionnaires are 15D quality of life, Raitasalo's modification of the Beck Inventory, and the Eating Disorder Inventory. We hypothesize that aesthetic body contouring plastic surgery has notable quality of life effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body contouring surgery | Experimental | Procedure: Abdominoplasty and liposuction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients requesting body contouring surgery
Key exclusion criteria (1 listed)
- previous abdominal aesthetic surgery, simultaneous other aesthetic surgery at the same time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominoplasty and liposuction | Procedure or surgery | Body contouring surgery |
Primary outcome
Quality of life
Time frame: 6 months
15D quality of life questionnaire RBDI mood questionnaire Eating Disorder Inventory questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Derived from this study: PubMed 25506426Saariniemi KM, Salmi AM, Peltoniemi HH, Helle MH, Charpentier P, Kuokkanen HO. Abdominoplasty improves quality of life, psychological distress, and eating disorder symptoms: a prospective study. Plast Surg Int. 2014;2014:197232. doi: 10.1155/2014/197232. Epub 2014 Nov 24.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abdominoplasty and liposuction in people with Subcutaneous Abdominal Fat and Abdominal Skin Elasticity, run by Tampere University Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02151799, which also lists 1 linked publication.
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 4 Nov 2015.