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CTRI Number  CTRI/2015/01/005440 [Registered on: 22/01/2015] Trial Registered Retrospectively
Last Modified On: 19/01/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   ENLARGEMENT OF MALE BREAST: OUTCOME OF MEDICAL AND SURGICAL MANAGEMENT 
Scientific Title of Study   INVESTIGATION OF CLINICAL TYPES, HORMONAL PROFILE AND TREATMENT OUTCOMES IN PATIENTS WITH GYNECOMASTIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subash Lohani  
Designation  Junior Resident  
Affiliation  AIIMS 
Address  Department of Surgical Disciplines, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9650462762  
Fax    
Email  subash.lohani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maneesh Singhal  
Designation  Additional Professor  
Affiliation  AIIMS 
Address  Department of Surgical Disciplines, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9868397713  
Fax    
Email  drmaneesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Subash Lohani  
Designation  Junior Resident  
Affiliation  AIIMS 
Address  Department of Surgical Disciplines, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9650462762  
Fax    
Email  subash.lohani@gmail.com  
 
Source of Monetary or Material Support  
AIIMS 
 
Primary Sponsor  
Name  AIIMS  
Address  Ansarinagar, New Delhi, 110029 
Type of Sponsor  Research institution and hospital 
 
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 
Subash Lohani   Department of Surgical Disciplines  Administrative Building, 5th floor, AIIMS, Ansari Nagar, New Delhi, 110029
South
DELHI 
9650462762

subash.lohani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Post-Graduate Research, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gynecomastia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  One stage subcutaneous mastectomy   Patients will undergo subcutaneous mastectomy of the entire enlarged breast in a single sitting  
Intervention  Two stage subcutaneous mastectomy  Patients will undergo subcutaneous mastectomy of upper half of the enlarged breast on first sitting, followed three months later by that of lower half of the breast. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Patients coming to surgical/ endocrinology OPD with the diagnosis of gynecomastia. 
 
ExclusionCriteria 
Details  1. Patients who are unwilling or unable to provide informed consent.
2. Patients who have contraindications to tamoxifen therapy viz history of thromboembolism, stroke, and coronary artery disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Cosmesis score   6 months from surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Surgical complications  Withing 6 months of surgery  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   09/07/2014 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Gynecomastia is a common condition such that nearly 40% all boys develop this condition during puberty and 36% of men aged 17-58 years have palpable breast tissue. Nearly two-thirds of patients have been reported in western literature to respond to tamoxifen therapy. In the rest, surgical management in pursued in the form of subcutaneuos mastectomy with good surgical results. There have been multiple case reports on gynecomastia from Indian sub-continent but not a single large series has yet been published. Here at AIIMS outpatient department, we come across a large number of patients with gynecomastia and operate on thirty to forty cases each year. Thus a dedicated reserch with an aim to document the clinical types, hormonal profile and treatment outcomes of gynecomastia will add up significantly to the existing literature.

 

In our study, patients with gynecomastia will be recruited from surgical or endocrinology OPD. Patients will be evaluated with clinical examination and pertinent investigations including ultrasound and biopsy. Patients will be prescribed 20 mg/day of tamoxifen for three to six months unless they have any contraindication to tamoxifen. Patients will be reassessed after three months of tamoxifen therapy to check the response. If there is significant reduction in breast volume (> 50% reduction) at three months, then tamoxifen will be continued for further 3 months. Patients with minimal or no response will be randomized to undergo either a one stage or 50-50 two stage subcutaneous mastectomy (half of the breast plate excised by circumareolar incision and repeat excision of remaining half 3 months later). Patients will be followed up in clinic for final surgical outcome assessment at 6 months.

 
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