GynecomastiaNCT04063722
Modified Benelli Procedure For Subcutaneous Mastectomy
A study testing modified Benelli procedure in people with Gynecomastia and Surgical Incision, run by Al-Kindy College of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecomastia, Surgical Incision
- What is being tested?
- modified Benelli procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 35 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- all patients with gynecomastia
Who cannot join
- Patients with Grade I gynecomastia because of no skin excess
- patients with grade IV due to the need of more extensive procedures
About this study
Official title: A Randomized Controlled Trial Modified Benelli Procedure For Subcutaneous Mastectomy In Gynecomastia
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.
Read the 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.
- Conditions
- Gynecomastia, Surgical Incision
- Being tested
- modified Benelli procedure
- Medical subject headings
- Gynecomastia, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Benelli procedureProcedure or surgery
use of modified Benelli procedure for surgical treatment of gynecomastia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: modified Benelli procedure |
| webester procedure | Active comparator | periareolar incision with excision of the breast tissue Receives: Procedure: modified Benelli procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Documented on one occasion, at 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start1 Jan 2010
- Primary completion1 Jan 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Kindy College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Riyadh M Hasan, C.A.B.S., Study chair, Al kindy college of medicine university of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063722
- Sponsor's protocol ID
- 7 Al-KindyCM
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2019
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Modified Benelli Procedure For Subcutaneous Mastectomy In Gynecomastia
- ClinicalTrials.gov ID
- NCT04063722
- Acronym / sponsor ID
- 7 Al-KindyCM
- Conditions
- Gynecomastia, Surgical Incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Al-Kindy College of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Benelli Procedure | Experimental | Procedure: modified Benelli procedurepoint 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. |
| webester procedure | Active comparator | Procedure: modified Benelli procedureperiareolar incision with excision of the breast tissue |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all patients with gynecomastia
Key exclusion criteria (2 listed)
- Patients with Grade I gynecomastia because of no skin excess
- patients with grade IV due to the need of more extensive procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified Benelli procedureuse of modified Benelli procedure for surgical treatment of gynecomastia | Procedure or surgery | Modified Benelli Procedure, webester procedure |
Primary outcome
prevalence of proper postoperative nipple-areolar complex position: the distance from the midclavicular point to the postoperative nipple areola complex position.
Time frame: Documented on one occasion, at 6 months postoperatively.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riyadh M Hasan, C.A.B.S. study chair
Al kindy college of medicine university of Baghdad
Questions about this trial
What is this clinical trial studying?
A study testing modified Benelli procedure in people with Gynecomastia and Surgical Incision, run by Al-Kindy College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of proper postoperative nipple-areolar complex position: the distance from the midclavicular point to the postoperative nipple areola complex position. (time frame: Documented on one occasion, at 6 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023; AzTrials last refreshed its copy on 28 Oct 2026.