GynecomastiaNCT04966078
Treatment of Mild and Moderate Cases of Gynaecomastia
A study testing liposuction and surgical excision in people with Gynecomastia, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to compare liposuction and periareolar surgical excision in mild and moderate cases of gynecomastia as regard cosmosis, complications, patient satisfaction, operation time, and hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Gynecomastia
- What is being tested?
- liposuction and surgical excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Feb 2022
- 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 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- The age of patients ranges from 18-60yrs. Mild and moderate cases of gynecomastia.
Who cannot join
- Patients with endocrine causes. Patients with genetic causes. Severe cases of gynecomastia. Patients who refused surgical intervention. Patients who are not fit for surgery. Patients with chronic illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Liposuction and Peri-areolar Surgical Excision in Mild and Moderate Cases of Gynaecomastia
This study aims to compare liposuction and periareolar surgical excision in mild and moderate cases of gynecomastia as regard cosmosis, complications, patient satisfaction, operation time, and hospital stay.
This study will be carried out on patients with gynecomastia presented to the Plastic Surgery Department, Sohag University, in the period between January 2021 to January 2022 as a retrospective and prospective study.
Patients will be divided into 2 groups:
group A treated with suction-assisted liposuction. group B treated with peri-areolar surgical excision. Each group contains 20 patients.
- Conditions
- Gynecomastia
- Being tested
- liposuction, surgical excision
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposuctionProcedure or surgery
suction-assisted liposuction
surgical excisionProcedure or surgery
periareolar surgical excision
| Study group | Role | What they receive |
|---|---|---|
| liposuction | Active comparator | group A will be treated with liposuction Receives: Procedure: liposuction |
| periareolar surgical excision | Active comparator | Group B will be treated with periareolar surgical excision Receives: Procedure: surgical excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between group A and B in aesthetic satisfaction
A 100 -point visual analogue scale (VAS) for the assessment of aesthetic satisfaction with 0 as the worst cosmosis and 100 as the best aesthetic result With filled standardized charts.
Measured: difference between group A and B in aesthetic results according to visual analogue scale at 3 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa eldeen abd elraheem mohamed, Sohag University
- Investigators
- Gamal Y Elsaied, MD, Study chair, sohag univeristy hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966078
- Sponsor's protocol ID
- Soh-Med-21-07-10
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- 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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Liposuction and Peri-areolar Surgical Excision in Mild and Moderate Cases of Gynaecomastia
- ClinicalTrials.gov ID
- NCT04966078
- Acronym / sponsor ID
- Soh-Med-21-07-10
- Conditions
- Gynecomastia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 19 Jul 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.
This study aims to compare liposuction and periareolar surgical excision in mild and moderate cases of gynecomastia as regard cosmosis, complications, patient satisfaction, operation time, and hospital stay.
This study will be carried out on patients with gynecomastia presented to the Plastic Surgery Department, Sohag University, in the period between January 2021 to January 2022 as a retrospective and prospective study.
Patients will be divided into 2 groups:
group A treated with suction-assisted liposuction. group B treated with peri-areolar surgical excision. Each group contains 20 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liposuction | Active comparator | Procedure: liposuctiongroup A will be treated with liposuction |
| periareolar surgical excision | Active comparator | Procedure: surgical excisionGroup B will be treated with periareolar surgical excision |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The age of patients ranges from 18-60yrs. Mild and moderate cases of gynecomastia.
Key exclusion criteria (1 listed)
- Patients with endocrine causes. Patients with genetic causes. Severe cases of gynecomastia. Patients who refused surgical intervention. Patients who are not fit for surgery. Patients with chronic illness.
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 |
|---|---|---|
| liposuctionsuction-assisted liposuction | Procedure or surgery | liposuction |
| surgical excisionperiareolar surgical excision | Procedure or surgery | periareolar surgical excision |
Primary outcome
Difference between group A and B in aesthetic satisfaction
Time frame: difference between group A and B in aesthetic results according to visual analogue scale at 3 month post-operative
A 100 -point visual analogue scale (VAS) for the assessment of aesthetic satisfaction with 0 as the worst cosmosis and 100 as the best aesthetic result With filled standardized charts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- 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.
Gamal Y Elsaied, MD study chair
sohag univeristy 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 liposuction and surgical excision in people with Gynecomastia, run by Sohag 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 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: status not confirmed, as of the sponsor's last update on 19 Jul 2021. 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?
Difference between group A and B in aesthetic satisfaction (time frame: difference between group A and B in aesthetic results according to visual analogue scale at 3 month post-operative). 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 19 Jul 2021.