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Clinical Trials in China / NCT07314086
Active, not recruiting Observational

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 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Harbin Medical University
Phase
Observational
Started
2021-09-01
Last updated
2026-01-02

Condition(s) studied

Gynecomastia

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: (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. Exclusion Criteria: (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.

Primary outcome measure(s)

  • Differences in the clinical index between the two groups — 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 — 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 — 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 — 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 — 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

Trial sites (1)

FacilityCityRegionStatus
First affiliated hospital of Harbin medical university Harbin Heilongjing

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07314086 on ClinicalTrials.gov ↗ ← All trials in China