Treatment of Mild and Moderate Cases of Gynaecomastia

Sponsor

Sohag University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04966078

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecomastia	Procedure: liposuction Procedure: surgical excision	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison Between Liposuction and Peri-areolar Surgical Excision in Mild and Moderate Cases of Gynaecomastia

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: liposuction group A will be treated with liposuction	Procedure: liposuction suction-assisted liposuction
Active Comparator: periareolar surgical excision Group B will be treated with periareolar surgical excision	Procedure: surgical excision periareolar surgical excision

Arm

Intervention/Treatment

Active Comparator: liposuction

group A will be treated with liposuction

Procedure: liposuction

suction-assisted liposuction

Active Comparator: periareolar surgical excision

Group B will be treated with periareolar surgical excision

Procedure: surgical excision

periareolar surgical excision

Outcome Measures

Primary Outcome Measures

Difference between group A and B in aesthetic satisfaction [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University	Sohag		Egypt	82525

Sponsors and Collaborators

Sohag University

Investigators

Study Chair: Gamal Y Elsaied, MD, sohag univeristy hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Diaa eldeen abd elraheem mohamed, principal investigator, Sohag University

ClinicalTrials.gov Identifier:

NCT04966078

Other Study ID Numbers:

Soh-Med-21-07-10

First Posted:

Jul 19, 2021

Last Update Posted:

Jul 19, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gynecomastia

Study Results

No Results Posted as of Jul 19, 2021