Skin; ExcessNCT04805424
Techniques for Abdominoplasty After Massive Weight Loss
A study testing Lipo-abdominoplasty and Abdominoplasty in people with Skin; Excess, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Excess skin on the abdomen is a common problem for many individuals after massive weight loss. The surgical procedure of abdominoplasty is intended to remove excess skin and improve the shape of the torso in abdomen, in order to address issues such as skin fold eczema, difficulties finding clothing, and psychosocial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin; Excess
- What is being tested?
- Lipo-abdominoplasty and Abdominoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2023to Jun 2025
- Phase
- Interventional
- 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
Who may be able to join
- BMI < 30
- Stable BMI for >= 6 months
- >= 24 months since bariatric surgery, if applicable
- Skin fold of >= 5 cm
- Functional and/or psychosocial issues due to abdominal skin excess
Who cannot join
- Smoking
- Ongoing infection
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Reconstructive Plastic Surgery, Karolinska University Hospital
Stockholm, 171 76
About this study
Official title: Different Techniques for Abdominoplasty After Massive Weight Loss: Safety and Outcomes
Excess skin on the abdomen is a common problem for many individuals after massive weight loss. The surgical procedure of abdominoplasty is intended to remove excess skin and improve the shape of the torso in abdomen, in order to address issues such as skin fold eczema, difficulties finding clothing, and psychosocial issues.
The investigators will conduct a randomized, controlled trial where individuals with excess skin on the abdomen will be randomized to either standard abdominoplasty or abdominoplasty in combination with liposuction. The investigators will examine the rate of complications, and the functional and aesthetical outcomes of the two methods.
- Conditions
- Skin; Excess
- Being tested
- Lipo-abdominoplasty, Abdominoplasty
- Keywords
- Randomized controlled trial, Abdominoplasty, Massive weight loss, Plastic surgery, Liposuction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipo-abdominoplastyProcedure or surgery
Abdominoplasty plus liposuction
AbdominoplastyProcedure or surgery
Abdominoplasty
| Study group | Role | What they receive |
|---|---|---|
| Abdominoplasty | Active comparator | Standard abdominoplasty Receives: Procedure: Abdominoplasty |
| Lipo-abdominoplasty | Experimental | Abdominoplasty plus liposuction Receives: Procedure: Lipo-abdominoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of and type of complications within 30 days
Number of and type of complications occurring within 30 days of surgery
Measured: 30 days
Secondary outcomes (4)
Average need for analgesia in morphine equivalents
Average need for analgesia in morphine equivalents during post-operative day 1
Measured: Post-operative day 1
Average score on BodyQ score
Average score on BodyQ score including subscales. BodyQ is developed and owned by Memorial Sloan Kettering Cancer Center. The BODY-Q is composed of 27 independently functioning scales that measure 3 overarching constructs Appearance, Quality of Life and Experience of Care. Scales are translated to a 0-100 score where a lower score means worse outcome.
Measured: At baseline, at 3 months post-operatively, at 12 months post-operatively
Average score on aesthetic result
Average score on aesthetic result on a 1-10 scale where a lower score means worse outcome.
Measured: At 12 months post-operatively
Average days until discharge
Average days until discharge post-operatively
Measured: Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study startJan 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: Karolinska University Hospital unable to support the clinical trial as anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin; ExcessStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebba Lindqvist, Karolinska University Hospital
- Investigators
- Ebba Lindqvist, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805424
- Sponsor's protocol ID
- 2020-06151
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Techniques for Abdominoplasty After Massive Weight Loss: Safety and Outcomes
- ClinicalTrials.gov ID
- NCT04805424
- Acronym / sponsor ID
- 2020-06151
- Conditions
- Skin; Excess
- Keywords
- Randomized controlled trial, Abdominoplasty, Massive weight loss, Plastic surgery, Liposuction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Karolinska University Hospital unable to support the clinical trial as anticipated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Mar 2021 (actual)
- 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.
Excess skin on the abdomen is a common problem for many individuals after massive weight loss. The surgical procedure of abdominoplasty is intended to remove excess skin and improve the shape of the torso in abdomen, in order to address issues such as skin fold eczema, difficulties finding clothing, and psychosocial issues.
The investigators will conduct a randomized, controlled trial where individuals with excess skin on the abdomen will be randomized to either standard abdominoplasty or abdominoplasty in combination with liposuction. The investigators will examine the rate of complications, and the functional and aesthetical outcomes of the two methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominoplasty | Active comparator | Procedure: AbdominoplastyStandard abdominoplasty |
| Lipo-abdominoplasty | Experimental | Procedure: Lipo-abdominoplastyAbdominoplasty plus liposuction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI < 30
- Stable BMI for >= 6 months
- >= 24 months since bariatric surgery, if applicable
- Skin fold of >= 5 cm
- Functional and/or psychosocial issues due to abdominal skin excess
Key exclusion criteria (2 listed)
- Smoking
- Ongoing infection
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 |
|---|---|---|
| Lipo-abdominoplastyAbdominoplasty plus liposuction | Procedure or surgery | Lipo-abdominoplasty |
| AbdominoplastyAbdominoplasty | Procedure or surgery | Abdominoplasty |
Primary outcome
Number of and type of complications within 30 days
Time frame: 30 days
Number of and type of complications occurring within 30 days of surgery
4 secondary outcomes
Average need for analgesia in morphine equivalents
Time frame: Post-operative day 1
Average score on BodyQ score
Time frame: At baseline, at 3 months post-operatively, at 12 months post-operatively
Average score on aesthetic result
Time frame: At 12 months post-operatively
Average days until discharge
Time frame: Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Ebba Lindqvist, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipo-abdominoplasty and Abdominoplasty in people with Skin; Excess, run by Karolinska University Hospital at 1 site in Sweden.
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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of and type of complications within 30 days (time frame: 30 days). 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 10 Mar 2023.