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CTRI Number  CTRI/2018/11/016341 [Registered on: 15/11/2018] Trial Registered Prospectively
Last Modified On: 22/04/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Single centre descriptive observational study 
Study Design  Other 
Public Title of Study   Study to observe clinical and pathological presentation of breast lump in female of Bihar 
Scientific Title of Study   A clinical-pathological study of benign breast disease in tertiary centre of Bihar. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mukesh kumar 
Designation  Associate professor 
Affiliation  igims patna 
Address  Department of general surgery,Indira gandhi institute of medical sciences, Patna.

Patna
BIHAR
800014
India 
Phone  9708309952  
Fax  0612-2297225  
Email  drmukeshk@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Mukesh kumar 
Designation  Associate professor 
Affiliation  igims patna 
Address  Department of general surgery, indira gandhi institute of medical sciences, patna.

Patna
BIHAR
800014
India 
Phone  9708309952  
Fax  0612-2297225  
Email  drmukeshk@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Mukesh kumar 
Designation  Associate professor 
Affiliation  igims patna 
Address  Department of general surgery,indira gandhi institute of medical sciences, patna.

Patna
BIHAR
800014
India 
Phone  9708309952  
Fax  0612-2297225  
Email  drmukeshk@yahoo.com  
 
Source of Monetary or Material Support  
Indira gandhi institute of medical sciences, patna 
 
Primary Sponsor  
Name  Dr mukesh kumar 
Address  Department of general surgery, indira gandhi institute of medical sciences, patna 
Type of Sponsor  Research institution 
 
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 
Dr mukesh kumar  Room no. 425, 4th floor, ward block, Department of general surgery,  Indira gandhi institute of medical sciences, patna.800014.
Patna
BIHAR 
9708309952
0612-2297225
drmukeshk@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics comittee, igims, patna.  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 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Female patients with benign disease of breast. for example breast lump, breast pain and nipple discharge. 
 
ExclusionCriteria 
Details  Female patients with obvious malignant disease or those who had treated for malignancy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical presentation such as breast lump, breast pain and nipple discharge.also fnac report and birads grade from usg or mammography of breast.  Clinical presentation such as breast lump, breast pain and nipple discharge.also fnac report and birads grade from usg or mammography of breast. 
 
Secondary Outcome  
Outcome  TimePoints 
To check malignant changes in benign breast disease  One year duration 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/11/2018 
Date of Study Completion (India) 15/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/03/2020 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
4. Khemka A, Chakravarti N, Shah S, Patel V. Palpable breast lumps: Fine needle aspiration cytology versus histopathology, a correlation of diagnostic accuracy. Internet J Surgery. 2009;18:1. 5. NavneetKaur, NitinAgarwal, Pankaj Parwar. Clinicopathological profile of benign breast conditions in Indian women. Prospective study based on aberrations of normal development and involution classification. World J Surgery. 2012; 36:2252-58. 6. A clinic-pathological study of benign breast disease in rural population. Das N et al. Int J Res Med Sci. 2014 Aug;2(3):1067-1069. 7. Study of various benign breast disease. SelvaKumran S et al. International surgery journal.2017 Jan;4(1):339-343.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Benign breast disease is most common problem in females of our society. Benign breast disease is a group of breast disease which is not a cancer. Up to 30% of women suffer from benign breast disease will require treatment at some time in their lives. A tripple assessment which include clinical examination, immazing ( mammography or USG of breast) and pathological examination (FNAC or Core needle biopsy), during initial consultation, allows majority of the patients with discrete benign breast disease and to be given immediate reassurance. Making an early diagnosis and planning the treatment within 72 hour of the first consultation, helps in alleviating unnecessary anxiety about breast cancer. Breast self examination and education to females is very important in cases of benign breast disease. so Reassuarance is the first step in treatment of benign breast disease. This is  observational  descriptive study which will be done regarding clinical pathological pattern of benign breast disease of 100 females patients in General surgery OPD in IGIMS patna over one year duration.The aims and objective of this study are to find out different clinical presentation of benign breast disease and there incidence, to know age wise distribution of benign breast disease, side wise distribution and incidence of different types of benign breast disease.

 
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