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Clinical Trials/CTRI/2019/07/020330
CTRI/2019/07/020330Not yet recruitingPhase 3

Evaluation of glandular liposculpture as a single treatment of Grade I/II Gynaecomastia

Indira gandhi institute of medical sciences1 site in 1 country50 target enrollmentStarted: January 8, 2019Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
50
Locations
1
Primary Endpoint
2. Satisfaction with overall outcome

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • •Anaesthesiologists physical status grade I or II adults aged 18 to 65 years Consenting patients.

Exclusion Criteria

  • •Non consenting patients Simon’s grade III gynaecomastia Suspicious neoplastic breast lesions.

Outcomes

Primary Outcomes

2. Satisfaction with overall outcome

Time Frame: At 3 months post operative

The outcomes will be analysed as per BREAST-Q RedMast V2.0 English .

Time Frame: At 3 months post operative

Satisfaction with breasts

Time Frame: At 3 months post operative

3. Psychosocial well-being

Time Frame: At 3 months post operative

4. Sexual well-being

Time Frame: At 3 months post operative

5. Physical well-being

Time Frame: At 3 months post operative

6. Satisfaction with care

Time Frame: At 3 months post operative

Secondary Outcomes

  • 3. Psychosocial well-being(1. Sexual well-being)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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