NCT04063722

Modified Benelli Procedure For Subcutaneous Mastectomy

Completed NA Last updated 21 July 2023

What this trial tests

NA trial testing modified Benelli procedure in Gynecomastia in 150 participants. Completed in 1 July 2016.

Timeline

1 January 2010

Primary endpoint
1 January 2016

1 July 2016

Quick facts

Lead sponsor	Al-Kindy College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	150
Start date	1 January 2010
Primary completion	1 January 2016
Estimated completion	1 July 2016

Drugs / interventions tested

• modified Benelli procedure

Conditions studied

• Gynecomastia — all drugs for Gynecomastia →
• Surgical Incision — all drugs for Surgical Incision →

Sponsor

Al-Kindy College of Medicine

Who can join

Adults 17 to 35, male only, with Gynecomastia or Surgical Incision. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Modified Benelli procedure for subcutaneous mastectomy in gynecomastia: A randomised controlled trial.
   Mohamad Hasan R. · · 2019 · cited 3× · PMID 31641496 · DOI 10.1016/j.amsu.2019.09.007