Back to resultsTreatment of Mild and Moderate Cases of Gynaecomastia
Primary Purpose
Gynecomastia
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
liposuction
surgical excision
Sponsored by
About this trial
This is an interventional treatment trial for Gynecomastia
Eligibility Criteria
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.
Sites / Locations
- Sohag University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
liposuction
periareolar surgical excision
Arm Description
group A will be treated with liposuction
Group B will be treated with periareolar surgical excision
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04966078
Brief Title
Treatment of Mild and Moderate Cases of Gynaecomastia
Official Title
Comparison Between Liposuction and Peri-areolar Surgical Excision in Mild and Moderate Cases of Gynaecomastia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecomastia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
liposuction
Arm Type
Active Comparator
Arm Description
group A will be treated with liposuction
Arm Title
periareolar surgical excision
Arm Type
Active Comparator
Arm Description
Group B will be treated with periareolar surgical excision
Intervention Type
Procedure
Intervention Name(s)
liposuction
Intervention Description
suction-assisted liposuction
Intervention Type
Procedure
Intervention Name(s)
surgical excision
Intervention Description
periareolar surgical excision
Primary Outcome Measure Information:
Title
Difference between group A and B in aesthetic satisfaction
Description
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.
Time Frame
difference between group A and B in aesthetic results according to visual analogue scale at 3 month post-operative
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamal Y Elsaied, MD
Organizational Affiliation
sohag univeristy hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sohag University
City
Sohag
ZIP/Postal Code
82525
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Mild and Moderate Cases of Gynaecomastia
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