- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04966078
Treatment of Mild and Moderate Cases of Gynaecomastia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sohag, Egypt, 82525
- Sohag University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The age of patients ranges from 18-60yrs. Mild and moderate cases of gynecomastia.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: liposuction
group A will be treated with liposuction
|
suction-assisted liposuction
|
Active Comparator: periareolar surgical excision
Group B will be treated with periareolar surgical excision
|
periareolar surgical excision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
difference between group A and B in aesthetic results according to visual analogue scale at 3 month post-operative
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gamal Y Elsaied, MD, sohag univeristy hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-07-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gynecomastia
-
Zagazig UniversityCompletedGynecomastia, AdolescentEgypt
-
Assiut UniversityActive, not recruitingSurgical Managment of GynecomastiaEgypt
-
Apyx MedicalCompletedGynecomastiaUnited States
-
Dermatology, Laser & Vein Specialists of the CarolinasUnknownGynecomastiaUnited States
-
Lawson Health Research InstituteNot yet recruitingBreast Cancer | Gynecomastia | Transgenderism | Breast Asymmetry
-
Franklin Health ResearchRecruiting
-
Al-Kindy College of MedicineCompletedGynecomastia | Surgical Incision
-
Groupe Hospitalier Paris Saint JosephCompleted
Clinical Trials on liposuction
-
AntriaCompletedSoft Tissue Mass RemovalUnited States
-
Assiut UniversityUnknown
-
University of AarhusCompletedMesenchymal Stem Cells
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Colorado...CompletedDisproportionate Shape | Expanded Fat PadsUnited States
-
Washington University School of MedicineCompletedDetermine Immune Cell Types in Subcutaneous Adipose TissueUnited States
-
Cairo UniversityUnknown
-
Tampere University HospitalCompletedSubcutaneous Abdominal Fat | Abdominal Skin Elasticity | Rectus Muscle Diastasis | Unpleasant Body Contour
-
Shanghai Jiao Tong University School of MedicineCompletedMenstrual Irregularity
-
Haraldsplass Deaconess HospitalUniversity Hospital of North Norway; University of Bergen; St. Olavs Hospital; Sykehuset... and other collaboratorsRecruiting
-
Abdelrahman Mostafa Shehata MohammedNot yet recruiting