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临床试验/NCT07314086
NCT07314086进行中(未招募)不适用

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

First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
Differences in the clinical index between the two groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • (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.

排除标准

  • (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.

结局指标

主要结局

Differences in the clinical index between the two groups

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • Differences in the postoperative complications between the two groups(baseline)

研究者

发起方
First Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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