| CTRI Number |
CTRI/2019/07/020330 [Registered on: 23/07/2019] Trial Registered Prospectively |
| Last Modified On: |
22/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Option of minimally invasive surgery for grade I/II Gynaecomastia |
|
Scientific Title of Study
|
Evaluation of glandular liposculpture as a single treatment of Grade I/II Gynaecomastia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
Indira gandhi institute of medical sciences |
| Address |
B405 Vamika Enclave
Jagdeopath
Patna
Bihar
Room no 425
Department of general surgery
IGIMS
Patna BIHAR 800014 India |
| Phone |
7836964003 |
| Fax |
|
| Email |
prashantrmlh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prashant Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
Indira gandhi institute of medical sciences |
| Address |
B405 Vamika Enclave
Jagdeopath
Patna
Bihar
Room no 425
Department of general surgery
IGIMS
BIHAR 800014 India |
| Phone |
7836964003 |
| Fax |
|
| Email |
prashantrmlh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prashant Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
Indira gandhi institute of medical sciences |
| Address |
B405 Vamika Enclave
Jagdeopath
Patna
Bihar
Room no 425
Department of general surgery
IGIMS
BIHAR 800014 India |
| Phone |
7836964003 |
| Fax |
|
| Email |
prashantrmlh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery
Indira Gandhi Istitute of Medical Sciences
Seikhpura
Patna
Bihar
800014
|
|
|
Primary Sponsor
|
| Name |
Indira gandhi institute of medical sciences |
| Address |
seikhpura
patna |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prashant Kumar Singh |
Indira gandhi institute of medical sciences |
Room no 425
Department of general surgery
Fourth floor
Ward block
Patna BIHAR |
7836964003
prashantrmlh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira gandhi institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glandular liposculpture as a minimally invasive procedure in cases of gynaecomastia. |
All patients will have their breasts examined for consistency (glandular, fat, or mixed), the position of the nipple–areola complex in relation to the inframammary line, and the symmetry of the breast. Secondary causes for gynaecomastia such as drugs or testicular tumors were excluded by clinical examination and hormonal blood assay for testosterone and estrogen.
Each patient will give signed informed consent accepting combined liposuction and liposculpturing (which may include possible secondary revision to remove remnants of tissue), possible complications of anesthesia, and possible complications particular to liposuction, mainly hematoma, asymmetry and irregularities of the breast, and having medical photographs taken before and after operation.
Surgical Technique
The infiltrate solution will be prepared (0.5 l saline + 1 mg 1/1000 adrenaline + 2% lidocaine 12.5 ml). A stab incision 5 mm long will be made 0.5–1 cm posterior to the anterior axillary line at the level of the sternal angle where the infiltration process will begin using a 3-mm straight blunt cannula with 20 holes, and the amount of fluid infiltrated will range between 400 and 750 ml according to the size of each breast. The two breasts will be infiltrated sequentially. We will wait 15–20 min after infiltration to start the aspiration.
We will use suction-assisted lipectomy in all cases. Tissue will be aspirated from two openings, the original stab made for infiltration, and another 10 cm inferior to the first, just posterior to the anterior axillary line. This will enable ‘‘crisscross’’ liposuction to achieve a smooth and even contour. A 5-mm blunt cannula will be used initially in the deep plane, followed by a 4-mm cannula to treat skin irregularities. The glandular tissue will be treated with a fat disruptor, which is a cannula 36 cm long with multiple holes 4 mm in size and barbed edges.
This facilitates the breakdown of the tough glandular tissue, particularly in the retroareolar area, keeping in mind the need to spare 1 cm or more of thickness to avoid inversion of the nipple–areola complex. The end point will be when an even contour had been achieved. Symmetry of the breasts was assessed primarily by bilateral pinch tests, as well as the duration of treatment for each breast. The openings will be left open for free drainage and no drains will be inserted.
A compression bandage will be applied around the chest for 4 days, followed by a liposuction garment for 6 weeks, which the patient could take it off only while having a shower.
All patients will be instructed to massage the two breasts frequently, starting from the first post-operative day, and they were encouraged to resume their regular physical exercise after 2 weeks.
The first follow-up visit will be usually on post-operative day four, mainly to exclude the presence of haematoma,infection or seroma and at 3 months for assessment of primary and secondary outcomes.
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Anaesthesiologists physical status grade I or II adults
aged 18 to 65 years
Consenting patients |
|
| ExclusionCriteria |
| Details |
Non consenting patients
Simon’s grade III gynaecomastia
Suspicious neoplastic breast lesions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Satisfaction with breasts
2. Satisfaction with overall outcome
3. Psychosocial well-being
4. Sexual well-being
5. Physical well-being
6. Satisfaction with care
The outcomes will be analysed as per BREAST-Q RedMast V2.0 English .
|
At 3 months post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3. Psychosocial well-being
1. Sexual well-being
2. Physical well-being
3. Satisfaction with care |
At 3 months post operative |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published yet but plan to publish the findings of the study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |