Surgical Managment of GynecomastiaNCT06473064
Evaluation of Feasibility and Aesthetic Outcomes of Benelli Technique for Nipple Sparing Mastectomy in Surgical Treatment of Grade 3 and 4 Gynecomastia
A study testing Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia in people with Surgical Managment of Gynecomastia, run by Assiut University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Surgical Managment of Gynecomastia
- What is being tested?
- Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 19 May 2023to 19 Oct 2025
- 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult male complaining of unilateral or bilateral grade 3 and 4 gynecomastia
- pseudo gynecomastia following massive weight loss with excess skin and laxity
Who cannot join
- patients with chronic liver failure
- hyperthyroidism
- Malignant mass
- Diabetics
- smokers
- patients with medical treatment as anabolic steroids .
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
- 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
- Surgical Managment of Gynecomastia
- Being tested
- Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastiaOther
.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
| Study group | Role | What they receive |
|---|---|---|
| grade 3 and 4 gynecomastia | Other | 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 Receives: Other: Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia
to evaluate and determine the feasibility and complications of benelli techniques for nipple sparing mastectomy in surgical tratment of grade 3 and 4 gynecomastia and also its cosmetic effect
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start19 May 2023
- Primary completion19 May 2025 (estimated)
- Study completion19 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical Managment of GynecomastiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- * 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezzat Essam Ezzat Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473064
- Sponsor's protocol ID
- Benelli technique gynecomastia
- Status last verified
- Jun 2024
- First submitted
- 19 May 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benelli L. A new periareolar mammaplasty: the "round block" technique. Aesthetic Plast Surg. 1990 Spring;14(2):93-100. doi: 10.1007/BF01578332.
PubMed 2185619Tarallo 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.
PubMed 31113185Colombo-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.
PubMed 10456706Letterman 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.
PubMed 3087145
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Feasibility and Aesthetic Outcomes of Benelli Technique for Nipple Sparing Mastectomy in Surgical Treatment of Grade 3 and 4 Gynecomastia
- ClinicalTrials.gov ID
- NCT06473064
- Acronym / sponsor ID
- Benelli technique gynecomastia
- Conditions
- Surgical Managment of Gynecomastia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 19 May 2025 (estimated)
- Study completion
- 19 Oct 2025 (estimated)
- First posted
- 25 Jun 2024 (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.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * 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
| Arm | Type | Receives |
|---|---|---|
| grade 3 and 4 gynecomastia | Other | Other: Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastiaTo 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult male complaining of unilateral or bilateral grade 3 and 4 gynecomastia
- pseudo gynecomastia following massive weight loss with excess skin and laxity
Key exclusion criteria (6 listed)
- patients with chronic liver failure
- hyperthyroidism
- Malignant mass
- Diabetics
- smokers
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 |
|---|---|---|
| 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 | Other | grade 3 and 4 gynecomastia |
Primary outcome
Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia
Time frame: baseline
to evaluate and determine the feasibility and complications of benelli techniques for nipple sparing mastectomy in surgical tratment of grade 3 and 4 gynecomastia and also its cosmetic effect
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Results publication: PubMed 2185619Benelli L. A new periareolar mammaplasty: the "round block" technique. Aesthetic Plast Surg. 1990 Spring;14(2):93-100. doi: 10.1007/BF01578332.
- Results publication: PubMed 31113185Tarallo 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.
- Results publication: PubMed 10456706Colombo-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.
- Results publication: PubMed 3087145Letterman 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia in people with Surgical Managment of Gynecomastia, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473064, which also lists 4 linked publications.
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 25 Jun 2024.