Modified Benelli Procedure For Subcutaneous Mastectomy

NCT04063722 | Completed

• 1 other identifier: 7 Al-KindyCM
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study included 150 patients with gynecomastia (Grade II and III) for the period between January 2010 and January 2016 who attended private hospitals and Al- Kindy Teaching Hospital. The patients were divided into two groups according to the operative techniques used. Group A included 75 patients treated surgically with subcutaneous mastectomy using periareolar incision. Group B; included the other 75 patients who were managed by "modified Benelli technique". The subcutaneous mastectomy using "modified Benelli technique" showed a significantly lower operating time due to ample access for excision of breast tissue. Excision of excess skin allowed the areola to retain a cosmetically more acceptable position. There was a lot of pleating of the skin compared to the other technique using the periareolar incision.

Conditions

Gynecomastia; Surgical Incision

Outcome Measures

Primary Outcomes (1)

• prevalence of proper postoperative nipple-areolar complex position: the distance from the midclavicular point to the postoperative nipple areola complex position.

  The distance from the midclavicular point to the nipple areola complex position were measured postoperatively, with an average of 6-month follow-up, to evaluate the aesthetic appropriateness of the postoperative nipple areola complex position which should be 18-19 cm from the midclavicular point.

  Documented on one occasion, at 6 months postoperatively.

Study Arms (2)

Modified Benelli Procedure

EXPERIMENTAL

point x refers to the point where the nipple areola complex should be placed at 18 cm from the mid clavicular line. line A is marked above and medial to the areola and a second radial line above it and parallel to it passing in the point (X) was made and named line B. The ends of this line is curved to approximate and connect to both ends of the line A . two incisions were made on the lines A and B . Next, the whole thickness of the excess skin between line A and the line B was excised (Simon classification 2A, 2B and 3) and subcutaneous mastectomy was done and sent to histopathology. Later on, bleeding control was done by good hemostasis and suction drain was put in its proper site. Finally subcuticular suturing was done by approximation of two incisions using Nylon 3/0. Lastly, sterile pressure dressing was placed.

Procedure: modified Benelli procedure

webester procedure

ACTIVE COMPARATOR

periareolar incision with excision of the breast tissue

Procedure: modified Benelli procedure

Interventions

modified Benelli procedure PROCEDURE

use of modified Benelli procedure for surgical treatment of gynecomastia

Modified Benelli Procedure; webester procedure

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all patients with gynecomastia

You may not qualify if:

• Patients with Grade I gynecomastia because of no skin excess
• patients with grade IV due to the need of more extensive procedures

Sponsors & Collaborators

• Al-Kindy College of Medicine: lead

MeSH Terms

Conditions

Gynecomastia; Surgical Wound

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Riyadh M Hasan, C.A.B.S.

  Al kindy college of medicine university of Baghdad

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 21, 2019
• Study Start: January 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 21, 2023

Record last verified: 2019-08