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

NCT ID: NCT06473064

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-19

Study Completion Date

2025-10-19

Brief Summary

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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

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• 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

Conditions

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Surgical Managment of Gynecomastia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

* 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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia

Intervention Type OTHER

.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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ezzat Essam Ezzat Osman

resident at general surgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Benelli L. A new periareolar mammaplasty: the "round block" technique. Aesthetic Plast Surg. 1990 Spring;14(2):93-100. doi: 10.1007/BF01578332.

Reference Type RESULT
PMID: 2185619 (View on PubMed)

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.

Reference Type RESULT
PMID: 31113185 (View on PubMed)

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.

Reference Type RESULT
PMID: 10456706 (View on PubMed)

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.

Reference Type RESULT
PMID: 3087145 (View on PubMed)

Other Identifiers

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Benelli technique gynecomastia

Identifier Type: -

Identifier Source: org_study_id

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