Evaluation of glandular liposculpture as a single treatment of Grade I/II Gynaecomastia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 2. Satisfaction with overall outcome
研究概览
简要总结
Gynecomastia refers to any enlargement of the male breast due to a proliferation of ductal, stromal, and/or fatty tissue. Transient enlargement is often seen in the infant or adolescent patient as a part of normal development, and in most patients, a period of observation is appropriate. Gynaecomastia is the most common disorder of the male breast, with a reported incidence of 36%.
There is a benign proliferation of the glandular tissue, unlike pseudogynaecomastia in which the enlargement is merely the result of obesity and deposition of fat .
Classification
Although various classification schemes have been proposed, those most often cited are those set forth by Simon and Rohrich (Tables 1)Letterman and Schurter proposed an early system based on operative requirements including skin excision and nipple repositioning. Simon moved away from this treatment-defined classification toward a qualitative classification of volume and skin redundancy dictating treatment.
| Grade 1 |
Small enlargement, no skin excess
|Grade 2a
Moderate enlargement, no skin excess
|Grade 2b
Moderate enlargement with extra skin
|Grade 3
Marked enlargement with extra skin
Table -1.Simon classification
Regardless of the type of gynaecomastia, if it persists for more than a year the breast tissue will become more fibrous and resistant to medical treatment. At this stage, resection is the mainstay of management
The psychological burden of gynaecomastia on the patients can be appreciable, making them at increased risk of psychological disorders such as depression, anxiety, and social phobia This necessitates intervention in most cases to restore the masculine look of the chest and achieve psychological satisfaction, particularly in grades I and II gynaecomastia in which excision of skin is seldom required. The presence of unsightly scars detracts from the success of the operation, despite the efficient reduction in breast volume and the skin envelope. Minimal scarring can be achieved by liposuction alone.
Although liposuction is known to have a limited effect on the dense glandular and fibroconnective tissues , these tissues tend to be infiltrated by enough fat for the liposuction cannula to be able to penetrate, to reduce the projection in the subareolar area, and to create a normal-looking chest wall with a dramatic retraction of the skin envelope that obviates the need for its excision. Recently, new types of cannulas have been introduced including fat disruptor cannulas on which the edges of the openings are barbed to improve efficient breakdown and liposculpturing of the dense glandular tissue.
We know of few studies published on liposuction alone for correction of gynaecomastia. We designed this study to evaluate the outcome (patients’ satisfaction and assessment by an independent observer) of combining liposuction with glandular liposculpturing through two axillary incisions as a single treatment for grades I and II gynaecomastia.
LACUNAE IN THE EXISTING KNOWLEDGE
1. There are very few studies regarding glandular liposculpture as a single treatment of grade I/II gynaecomastia.
In the era of minimally invasive surgery, minimizing the surgical access intervention needs to be evaluated and guidelines on their efficacy be formulated, which is still lacking regarding glandular liposculpture technique.
Research question
To evaluate glandular liposcupture as a single treatment of grade I/II gynaecomastia
Hypothesis
The study hypothesises that glandular liposculpture can be a single treatment of grade I/II gynaecomastia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Male
入选标准
- •Anaesthesiologists physical status grade I or II adults aged 18 to 65 years Consenting patients.
排除标准
- •Non consenting patients Simon’s grade III gynaecomastia Suspicious neoplastic breast lesions.
结局指标
主要结局
2. Satisfaction with overall outcome
时间窗: At 3 months post operative
The outcomes will be analysed as per BREAST-Q RedMast V2.0 English .
时间窗: At 3 months post operative
Satisfaction with breasts
时间窗: At 3 months post operative
3. Psychosocial well-being
时间窗: At 3 months post operative
4. Sexual well-being
时间窗: At 3 months post operative
5. Physical well-being
时间窗: At 3 months post operative
6. Satisfaction with care
时间窗: At 3 months post operative
次要结局
- 3. Psychosocial well-being(1. Sexual well-being)
