GynecomastiaNCT07314086
A Clinical Effectiveness Study of Total Laparoscopic Subcutaneous Gland Resection Combined With Nipple-Areola Complex Lift in the Management of Moderate to Severe Gynecomastia in Males
An observational study of Gynecomastia, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
This study aims to evaluate and compare the treatment outcomes of total laparoscopic subcutaneous gland resection combined with nipple-areola complex (NAC) lift surgery against those of isolated laparoscopic surgery in the management of moderate to severe gynecomastia (GYN) in males. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Gynecomastia
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe GYN conditions who were treated at the Breast Surgery Department of the First Affiliated Hospital of Harbin Medical University were included.
Who may be able to join
- Those with bilateral breast development confirmed by preoperative ultrasound examination; (2) For bilateral developed breasts, the preoperative classification according to Simon's system (hereinafter referred to as Simon classification) is all at grade IIA or above.
Who cannot join
- Benign and malignant tumors of the male breast; (2) Other diseases such as testicular tumors, congenital testicular dysplasia syndrome, hyperthyroidism, liver cirrhosis, primary gonadal hypofunction and oral medications can lead to secondary male breast development; (3) Patients with severe primary diseases such as cardiovascular and cerebrovascular diseases, liver and kidney diseases, and coagulation disorders are not suitable for anesthesia and surgery; (4) Patients with incomplete clinical case data.
Trial locations and contacts
1 site in 1 country.
China1 site
First affiliated hospital of Harbin medical university
Harbin, Heilongjing, 150001
About this study
This study aims to evaluate and compare the treatment outcomes of total laparoscopic subcutaneous gland resection combined with nipple-areola complex (NAC) lift surgery against those of isolated laparoscopic surgery in the management of moderate to severe gynecomastia (GYN) in males.
Read the detailed description
Gynecomastia (GYN), characterized by unilateral or bilateral breast enlargement, has an incidence ranging from approximately 32.0% to 64.6%, with a progressively increasing trend observed in recent years . Clinically, GYN is categorized into primary and secondary forms: the former is associated with physiological fluctuations in hormonal levels, whereas the latter is primarily attributable to underlying metabolic or neoplastic conditions, as well as medication use. Surgical intervention remains the mainstay of treatment for persistent or symptomatic cases. Given that the male breast is a solid, non-cavitary organ, conventional open surgical approaches have traditionally employed periareolar, crescentic, or double-ring incisions to excise subcutaneous glandular tissue . These techniques, however, are often associated with conspicuous scarring, suboptimal cosmetic results, and relatively high rates of postoperative complications. The advent of liposuction and tumescent lipolysis techniques in the 1990s overcame the technical challenge of cavity creation, thereby facilitating the development of endoscopic approaches. Over the past decade, significant advancements have been achieved through the integration of lipolysis and non-lipolysis techniques, concealed incision sites (e.g., axillary or lateral thoracic approaches), multi-port and single-port endoscopic systems, and robotic-assisted surgery using the Da Vinci Si platform . As a result, the therapeutic objective has evolved from mere glandular excision toward achieving optimal aesthetic outcomes with minimal visible scarring. The 2021 Expert Consensus and Operational Guidelines for Endoscopic Surgery in Breast Diseases established the 5S principles for GYN surgery: (1) complete removal of glandular tissue (sweep); (2) placement of inconspicuous, hidden incisions (scarless); (3) bilateral symmetry; (4) restoration of normal male chest contour (shape); and (5) smooth postoperative skin surface (smoothing) . Nevertheless, in patients with moderate to severe GYN, redundant skin following endoscopic resection frequently leads to malposition of the nipple-areola complex (NAC), including ptosis, depression, or wrinkling, which compromises skin smoothness and undermines both the 5S goals and overall aesthetic satisfaction. To address this limitation, our research team has developed an innovative technique termed the "Nipple-Areola Complex (NAC) Aesthetic Wrinkle-Reducing Band Lifting and Fixation Technique." This minimally invasive approach effectively manages postoperative skin redundancy without additional incisions, enabling precise repositioning of the NAC and improving skin contour. Statistical analysis demonstrates that this technique contributes significantly to enhancing aesthetic outcomes and patient satisfaction in the management of moderate to severe GYN.
- Conditions
- Gynecomastia
- Keywords
- gynecomastia, laparoscopic surgery
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | the group undergoing laparoscopic surgery combined with NAC lift | |
| control group | the group undergoing simple laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the clinical index between the two groups
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences between the two groups in terms of surgical time, blood loss, and drainage tube placement duration
Measured: Baseline
Difference in the pre- and postoperative convexity of breast between the two groups
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences between the two groups in terms of the pre- and postoperative convexity of breast
Measured: Baseline
Difference in the recovery rate of skin flatness between the two groups
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences of the recovery rate of skin flatness between the group undergoing laparoscopic surgery combined with NAC lift and he group undergoing simple laparoscopic surgery at 3, 6, and 12 months postoperatively
Measured: Baseline
Difference in the positioning of the NAC between the two groups
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences between the two groups in terms of the positioning of the NAC
Measured: Baseline
Differences in the postoperative patient satisfaction between the two groups
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences between the two groups in terms of postoperative patient satisfaction
Measured: Baseline
Secondary outcomes (1)
Differences in the postoperative complications between the two groups
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences between the two groups in terms of the postoperative complications
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Sep 2021
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314086
- Sponsor's protocol ID
- 20251129
- Status last verified
- Nov 2025
- First submitted
- 17 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Effectiveness Study of Total Laparoscopic Subcutaneous Gland Resection Combined With Nipple-Areola Complex Lift in the Management of Moderate to Severe Gynecomastia in Males
- ClinicalTrials.gov ID
- NCT07314086
- Acronym / sponsor ID
- 20251129
- Conditions
- Gynecomastia
- Keywords
- gynecomastia, laparoscopic surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 2 Jan 2026 (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.
This study aims to evaluate and compare the treatment outcomes of total laparoscopic subcutaneous gland resection combined with nipple-areola complex (NAC) lift surgery against those of isolated laparoscopic surgery in the management of moderate to severe gynecomastia (GYN) in males.
Detailed description
Gynecomastia (GYN), characterized by unilateral or bilateral breast enlargement, has an incidence ranging from approximately 32.0% to 64.6%, with a progressively increasing trend observed in recent years . Clinically, GYN is categorized into primary and secondary forms: the former is associated with physiological fluctuations in hormonal levels, whereas the latter is primarily attributable to underlying metabolic or neoplastic conditions, as well as medication use. Surgical intervention remains the mainstay of treatment for persistent or symptomatic cases. Given that the male breast is a solid, non-cavitary organ, conventional open surgical approaches have traditionally employed periareolar, crescentic, or double-ring incisions to excise subcutaneous glandular tissue . These techniques, however, are often associated with conspicuous scarring, suboptimal cosmetic results, and relatively high rates of postoperative complications. The advent of liposuction and tumescent lipolysis techniques in the 1990s overcame the technical challenge of cavity creation, thereby facilitating the development of endoscopic approaches. Over the past decade, significant advancements have been achieved through the integration of lipolysis and non-lipolysis techniques, concealed incision sites (e.g., axillary or lateral thoracic approaches), multi-port and single-port endoscopic systems, and robotic-assisted surgery using the Da Vinci Si platform . As a result, the therapeutic objective has evolved from mere glandular excision toward achieving optimal aesthetic outcomes with minimal visible scarring. The 2021 Expert Consensus and Operational Guidelines for Endoscopic Surgery in Breast Diseases established the 5S principles for GYN surgery: (1) complete removal of glandular tissue (sweep); (2) placement of inconspicuous, hidden incisions (scarless); (3) bilateral symmetry; (4) restoration of normal male chest contour (shape); and (5) smooth postoperative skin surface (smoothing) . Nevertheless, in patients with moderate to severe GYN, redundant skin following endoscopic resection frequently leads to malposition of the nipple-areola complex (NAC), including ptosis, depression, or wrinkling, which compromises skin smoothness and undermines both the 5S goals and overall aesthetic satisfaction. To address this limitation, our research team has developed an innovative technique termed the "Nipple-Areola Complex (NAC) Aesthetic Wrinkle-Reducing Band Lifting and Fixation Technique." This minimally invasive approach effectively manages postoperative skin redundancy without additional incisions, enabling precise repositioning of the NAC and improving skin contour. Statistical analysis demonstrates that this technique contributes significantly to enhancing aesthetic outcomes and patient satisfaction in the management of moderate to severe GYN.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –the group undergoing laparoscopic surgery combined with NAC lift |
| control group | – | –the group undergoing simple laparoscopic surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe GYN conditions who were treated at the Breast Surgery Department of the First Affiliated Hospital of Harbin Medical University were included.
Key inclusion criteria (1 listed)
- Those with bilateral breast development confirmed by preoperative ultrasound examination; (2) For bilateral developed breasts, the preoperative classification according to Simon's system (hereinafter referred to as Simon classification) is all at grade IIA or above.
Key exclusion criteria (1 listed)
- Benign and malignant tumors of the male breast; (2) Other diseases such as testicular tumors, congenital testicular dysplasia syndrome, hyperthyroidism, liver cirrhosis, primary gonadal hypofunction and oral medications can lead to secondary male breast development; (3) Patients with severe primary diseases such as cardiovascular and cerebrovascular diseases, liver and kidney diseases, and coagulation disorders are not suitable for anesthesia and surgery; (4) Patients with incomplete clinical case data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in the clinical index between the two groups
Time frame: Baseline
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences between the two groups in terms of surgical time, blood loss, and drainage tube placement duration
Difference in the pre- and postoperative convexity of breast between the two groups
Time frame: Baseline
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences between the two groups in terms of the pre- and postoperative convexity of breast
Difference in the recovery rate of skin flatness between the two groups
Time frame: Baseline
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences of the recovery rate of skin flatness between the group undergoing laparoscopic surgery combined with NAC lift and he group undergoing simple laparoscopic surgery at 3, 6, and 12 months postoperatively
Difference in the positioning of the NAC between the two groups
Time frame: Baseline
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences between the two groups in terms of the positioning of the NAC
Differences in the postoperative patient satisfaction between the two groups
Time frame: Baseline
The patients were divided into two groups: laparoscopic surgery in conjunction with NAC lift group,isolated laparoscopic surgery group. IBM SPSS 27.0 software was used for statistical analysis. The analysis attempt to reveal the differences between the two groups in terms of postoperative patient satisfaction
1 secondary outcome
Differences in the postoperative complications between the two groups
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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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.
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?
An observational study of Gynecomastia, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Differences in the clinical index between the two groups (time frame: Baseline). The study lists 5 primary outcomes in all. 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 2 Jan 2026.