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

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: Surgical Managment of Gynecomastia
• Intervention / Treatment: Other: Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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 materialHence, 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	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

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Benelli L. A new periareolar mammaplasty: the "round block" technique. Aesthetic Plast Surg. 1990 Spring;14(2):93-100. doi: 10.1007/BF01578332.
• Tarallo M, Di Taranto G, Fallico N, Ribuffo D. The round-the-clock technique for correction of gynecomastia. Arch Plast Surg. 2019 May;46(3):221-227. doi: 10.5999/aps.2018.00472. Epub 2019 May 15.
• Colombo-Benkmann M, Buse B, Stern J, Herfarth C. Indications for and results of surgical therapy for male gynecomastia. Am J Surg. 1999 Jul;178(1):60-3. doi: 10.1016/s0002-9610(99)00108-7.
• Letterman G, Schurter M. Suggested nomenclature for aesthetic and reconstructive surgery of the breast. Part III: Gynecomastia. Aesthetic Plast Surg. 1986;10(1):55-7. doi: 10.1007/BF01575270. No abstract available.

Study record dates

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: Skin Diseases; Breast Diseases; Gynecomastia
• 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