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Modified Benelli Procedure For Subcutaneous Mastectomy

Primary Purpose

Gynecomastia, Surgical Incision

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
modified Benelli procedure
Sponsored by
Al-Kindy College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecomastia

Eligibility Criteria

17 Years - 35 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • all patients with gynecomastia

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Modified Benelli Procedure

    webester procedure

    Arm Description

    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.

    periareolar incision with excision of the breast tissue

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 30, 2019
    Last Updated
    July 19, 2023
    Sponsor
    Al-Kindy College of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04063722
    Brief Title
    Modified Benelli Procedure For Subcutaneous Mastectomy
    Official Title
    A Randomized Controlled Trial Modified Benelli Procedure For Subcutaneous Mastectomy In Gynecomastia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2010 (Actual)
    Primary Completion Date
    January 1, 2016 (Actual)
    Study Completion Date
    July 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Al-Kindy College of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Patients with true gynecomastia, attending Al-Kindy Teaching Hospital and private hospitals, Baghdad, Iraq, from January 2010 to January 2016 were enrolled in the study. Grading of gynecomastia was done according to Cordova and Moschella classification (6). Patients with Grade I were excluded because of no skin excess, while grade IV were excluded due to the need of more extensive procedures. The study protocol was reviewed and approved by the Scientific and Ethical Committee of Al-Kindy College of medicine and Al-kindy Teaching hospital in the committee number 6 in 20-5-2019 (Ethical approval number and Date). Written informed consents were obtained from all patients as an action on acceptance. All enrolled patients were operated by the same surgeon. Patients were randomly assigned to one of the following surgical technique: Group A; included patients who underwent subcutaneous mastectomy using periareolar incision with lateral and medial extension as needed according to Webster(12). Group B; included patients who were treated by the proposed Modified Benelli Technique (MBT) using the following operative procedure: First ask the patient to stand up and draw the a line referring to the midline of the chest then mark the ideal breast meridian at 18 cm from midclavicular point to show the position where the nipple should be placed (point X) with skin marker pen and assess the quantity of surplus skin to be excised. After that, ask the patient to lie down on the couch and a periareolar line was marked ( line A) 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 . Then, the patient is given general anesthesia and the two incisions were made on the lines A and B i.e. periareolar incision above and medial to the areola with a second incision above it and connecting both ends . 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. The result of both groups were compared in terms of operating time, nipple-areola complex location, post-operative complications including, pleating of the skin at suture line, hematoma, bruising at the site of incision, , soft tissue deformity, seroma, hypoesthesia of nipple-areola complex, wound dehiscence, areolar epidermolysis, and hypertrophic scarring.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gynecomastia, Surgical Incision

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Modified Benelli Procedure
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    webester procedure
    Arm Type
    Active Comparator
    Arm Description
    periareolar incision with excision of the breast tissue
    Intervention Type
    Procedure
    Intervention Name(s)
    modified Benelli procedure
    Intervention Description
    use of modified Benelli procedure for surgical treatment of gynecomastia
    Primary Outcome Measure Information:
    Title
    prevalence of proper postoperative nipple-areolar complex position: the distance from the midclavicular point to the postoperative nipple areola complex position.
    Description
    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.
    Time Frame
    Documented on one occasion, at 6 months postoperatively.

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: all patients with gynecomastia Exclusion Criteria: Patients with Grade I gynecomastia because of no skin excess patients with grade IV due to the need of more extensive procedures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Riyadh M Hasan, C.A.B.S.
    Organizational Affiliation
    Al kindy college of medicine university of Baghdad
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Modified Benelli Procedure For Subcutaneous Mastectomy

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