LiposuctionNCT05680324
Impact of Monsplasty in Women Undergoing Abdominoplasty
A study testing Monsplasty in people with Liposuction and Mons Pubis Lift, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluate The aesthetic and function satisfaction outcomes of different monsplasty surgery with or after abdominoplasty Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Liposuction, Mons Pubis Lift
- What is being tested?
- Monsplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2021to May 2023
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any adult married woman from 20 to 45 years old candidate for abdominoplasty with stable weight in last 6 months
Who cannot join
- patients less than 20 years old and more than 45 years old
- patients with medical conditions affecting wound healing
- patients with skin infection in lower abdomen and pubic area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Aesthetic and Functional Impact of Monsplasty in Women Undergoing Abdominoplasty
Evaluate The aesthetic and function satisfaction outcomes of different monsplasty surgery with or after abdominoplasty
Read the detailed description
The high incidence of female obesity has resulted in common complaints of a large mons pubis and labia majora (outer labial lips) related to unsightly fat deposits. The mons and labia majora enlarge, protrude, descend, and hang. Even with dramatic weight loss, these areas remain descended and bulky, with excess fat and skin. The affected majora can cause difficulty with sexual intercourse and maintenance of hygiene, and result in discomfort when wearing pants and swimsuits. These unnatural .fat deposits can also severely affect self-esteem
The surgical treatment of the enlarged mons pubis and labia majora has been poorly understood and therefore often neglected. Traditionally, the mons has been treated by fat reduction, whether by liposuction or open excision, along with a pubic skin lift. However, skin elevation is usually unsatisfactory, because the mons will descend again upon standing. Many of these unsuccessful lifts present after a simultaneous abdominoplasty.
In many ways, the treatment of the mons pubis correlates with the treatment of the hidden penis in the obese or formerly obese male.1-3 Excess suprapubic skin and mons fat removal-along with tacking of the fibrofatty tissue of the pubic skin flap to the rectus fascia-are mandatory to achieve a lasting, successful mons pubis lift.4 Labia majora reduction. Depends on the surgically appropriate removal of fat and/or skin
- Conditions
- Liposuction, Mons Pubis Lift
- Being tested
- Monsplasty
- Keywords
- monsplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonsplastyProcedure or surgery
liposuction assisted monsplasty
| Study group | Role | What they receive |
|---|---|---|
| Abdominoplasty with Monsplasty | Active comparator | Not described Receives: Procedure: Monsplasty |
| Abdominoplasty without monsplasty | Active comparator | Not described Receives: Procedure: Monsplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine better result
Determine which is bettereither abdominoplast with monsplasty or abdominoplasty alone by a questionnaire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start10 Oct 2021
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiposuctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680324
- Sponsor's protocol ID
- MMhassan
- Status last verified
- Dec 2022
- First submitted
- 26 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Aesthetic and Functional Impact of Monsplasty in Women Undergoing Abdominoplasty
- ClinicalTrials.gov ID
- NCT05680324
- Acronym / sponsor ID
- MMhassan
- Conditions
- Liposuction, Mons Pubis Lift
- Keywords
- monsplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 11 Jan 2023 (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.
Evaluate The aesthetic and function satisfaction outcomes of different monsplasty surgery with or after abdominoplasty
Detailed description
The high incidence of female obesity has resulted in common complaints of a large mons pubis and labia majora (outer labial lips) related to unsightly fat deposits. The mons and labia majora enlarge, protrude, descend, and hang. Even with dramatic weight loss, these areas remain descended and bulky, with excess fat and skin. The affected majora can cause difficulty with sexual intercourse and maintenance of hygiene, and result in discomfort when wearing pants and swimsuits. These unnatural .fat deposits can also severely affect self-esteem
The surgical treatment of the enlarged mons pubis and labia majora has been poorly understood and therefore often neglected. Traditionally, the mons has been treated by fat reduction, whether by liposuction or open excision, along with a pubic skin lift. However, skin elevation is usually unsatisfactory, because the mons will descend again upon standing. Many of these unsuccessful lifts present after a simultaneous abdominoplasty.
In many ways, the treatment of the mons pubis correlates with the treatment of the hidden penis in the obese or formerly obese male.1-3 Excess suprapubic skin and mons fat removal-along with tacking of the fibrofatty tissue of the pubic skin flap to the rectus fascia-are mandatory to achieve a lasting, successful mons pubis lift.4 Labia majora reduction. Depends on the surgically appropriate removal of fat and/or skin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominoplasty with Monsplasty | Active comparator | Procedure: Monsplasty |
| Abdominoplasty without monsplasty | Active comparator | Procedure: Monsplasty |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any adult married woman from 20 to 45 years old candidate for abdominoplasty with stable weight in last 6 months
Key exclusion criteria (3 listed)
- patients less than 20 years old and more than 45 years old
- patients with medical conditions affecting wound healing
- patients with skin infection in lower abdomen and pubic area
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 |
|---|---|---|
| Monsplastyliposuction assisted monsplasty | Procedure or surgery | Abdominoplasty with Monsplasty, Abdominoplasty without monsplasty |
Primary outcome
Determine better result
Time frame: 3 years
Determine which is bettereither abdominoplast with monsplasty or abdominoplasty alone by a questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monsplasty in people with Liposuction and Mons Pubis Lift, run by Assiut University at 1 site in Egypt.
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 3 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 11 Jan 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 Egypt. 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?
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?
Determine better result (time frame: 3 years). 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 11 Jan 2023.