Evaluation of Feasibility and Aesthetic Outcomes of Benelli Technique for Nipple Sparing Mastectomy in Surgical Treatment of Grade 3 and 4 Gynecomastia

June 17, 2024 updated by: Ezzat Essam Ezzat Osman, Assiut University

Gynecomastia is the benign proliferation of male breast tissue caused by an increase in the estrogen/androgen activity ratio. It manifests itself physiologically (adolescence, puberty, and old age) as well as pathologically (androgen insufficiency caused by drugs or disease, testicular tumors, hyperthyroidism, and chronic renal failure).

  • In spite of the variety of methods and tools such as (liposuction and circumareolar inframammary inscion ) used in gynecomastia surgery, in gynecomastia the results are satisfactory in grades 1 and 2 while grades 3 and 4 gynecomastia present a surgical challenge.
  • As some postoperative frustrating problems still cannot be completely eliminated, the most common of these are a saucer-like deformity (over resection under areola), bleeding, followed by seroma, infection, ischemic necrosis of nipple areola complex residual gynecomastia (under resection), persistence of inframammary fold, contour irregularities, and asymmetries between breasts.
  • the objective, in this research, is to demonstrate the The role of Benelli technique in removal of gynecomastia grade 3 and grade 4 in clinical and cosmetic outcomes

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

• The aim of this study the investigator determines the feasibility and cosmetic outcomes of Benelli technique for nipple sparing mastectomy in cases of grade 3 and 4 gynecomastia

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 0882
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adult male complaining of unilateral or bilateral grade 3 and 4 gynecomastia
  • pseudo gynecomastia following massive weight loss with excess skin and laxity

Exclusion Criteria:

  • patients with chronic liver failure
  • hyperthyroidism
  • Malignant mass
  • Diabetics
  • smokers
  • patients with medical treatment as anabolic steroids .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: grade 3 and 4 gynecomastia
To evaluate and determine the posibility of complication of benelli technique for nipple sparing mastectomy in surgical treatment of grade 3and 4 gynecomastia and its cosmetic effect
Other: Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia

.The Nipple areola complex (NAC )margins on both sides are marked as circular. -Around the initial circle, a second circle (external) was drawn 1 cm broader than the boundary.

  • The skin was resected, with deepithelialization between the two circles.

  • A transdermal incision was made through the border of the external circle.

    -. The breast tissue around the pedicle was lifted over the pectoral fascia and excised by preserving the NAC and the underlying breast pedicle

  • The base of the mammary pedicle under the NAC was infixed at the farthest end of the mastectomy area by using 3/0 absorbable multifilament suture material

    • Hence, the space formed after mastectomy was filled with a breast pedicle located posterior to the NAC.
    • The closure of the circular deepithelialized area around the NAC with a diameter of 1 cm accomplished by using 4/0 absorbable monofilament suture material and the surgery was completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia
Time Frame: baseline
to evaluate and determine the feasibility and complications of benelli techniques for nipple sparing mastectomy in surgical tratment of grade 3 and 4 gynecomastia and also its cosmetic effect
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2023

Primary Completion (Estimated)

May 19, 2025

Study Completion (Estimated)

October 19, 2025

Study Registration Dates

First Submitted

May 19, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Benelli technique gynecomastia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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