| 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
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansarinagar, New Delhi, 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| 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
|
|
|
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. |