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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast,  
 
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.

 


 
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