Clinical trial NCT06473064: Evaluation of Feasibility and Aesthetic Outcomes of Benelli Technique for Nipple Sparing Mastectomy in Surgical Treatment of Grade 3 and 4 Gynecomastia
Official title: Evaluation of Feasibility and Aesthetic Outcomes of Benelli Technique for Nipple Sparing Mastectomy in Surgical Treatment of Grade 3 and 4 Gynecomastia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgical Managment of Gynecomastia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: * 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
Primary purpose: TREATMENT

Brief summary: 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

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

Eligibility criteria: 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 .

Primary outcomes:
measure: Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
citation: Benelli L. A new periareolar mammaplasty: the "round block" technique. Aesthetic Plast Surg. 1990 Spring;14(2):93-100. doi: 10.1007/BF01578332.
citation: 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.
citation: 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.
citation: 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.