NCT04966078

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 13, 2021

Last Update Submit

July 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    difference between group A and B in aesthetic results according to visual analogue scale at 3 month post-operative

Study Arms (2)

liposuction

ACTIVE COMPARATOR

group A will be treated with liposuction

Procedure: liposuction

periareolar surgical excision

ACTIVE COMPARATOR

Group B will be treated with periareolar surgical excision

Procedure: surgical excision

Interventions

liposuctionPROCEDURE

suction-assisted liposuction

liposuction

periareolar surgical excision

periareolar surgical excision

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- The age of patients ranges from 18-60yrs. Mild and moderate cases of gynecomastia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82525, Egypt

Location

MeSH Terms

Conditions

Gynecomastia

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Breast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Gamal Y Elsaied, MD

    sohag univeristy hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 19, 2021

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations