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

NCT07314086 | Active Not Recruiting DMC

• 1 other identifier: 20251129
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecomastia

Keywords

gynecomastia; laparoscopic surgery

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  Baseline

Secondary Outcomes (1)

• Differences in the postoperative complications between the two groups

  baseline

Study Arms (2)

experimental group

the group undergoing laparoscopic surgery combined with NAC lift

control group

the group undergoing simple laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• (1) 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.

You may not qualify if:

• (1) 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.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First affiliated hospital of Harbin medical university

Harbin, Heilongjing, 150001, China

Location

MeSH Terms

Conditions

Gynecomastia

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start: September 1, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)