RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

SYNOPSIS

OF

DISSERTATION

“A CLINICAL STUDY OF BENIGN BREAST DISEASES”

Submitted by

Dr. TEJUS V NAGI REDDY

MBBS

POST GRADUATE STUDENT IN

GENERAL SURGERY (M.S.)

Under the guidance of

Dr. S.N. LINGE GOWDA

M.B.B.S, M.S, FRCS (Edin)

PROFESSOR

DEPARTMENT OF GENERAL SURGERY

S.A.H. & R.C., B.G.NAGARA

DEPARTMENT OF GENERAL SURGERY

ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,

B.G.NAGARA-571448

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / Dr. TEJUS V NAGI REDDY
NO. 74, KALPATARU BHAVAN,
A.I.M.S., B.G.NAGARA,
NAGAMANGALA TALUK,
MANDYA DISTRICT,
KARNATAKA-571448.
2. / NAME OF THE INSTITUTION / SRI ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES, B.G.NAGARA
3. / COURSE OF THE STUDY & SUBJECT /

M.S. IN GENERAL SURGERY

4. / DATE OF ADMISSION TO COURSE / 13th JUNE 2013
5. / TITLE OF THE TOPIC / “A CLINICAL STUDY OF BENIGN BREAST DISEASES”
6. / BRIEF RESUME OF INTENDED WORK
6.1 NEED FOR THE STUDY
6.2 REVIEW OF THE LITERATURE
6.3 OBJECTIVES OF THE STUDY / APPENDIX – I
APPENDIX – IA
APPENDIX – IB
APPENDIX – IC
7. / MATERIALS AND METHODS
7.1 SOURCE OF DATA
7.2 METHOD OF COLLECTION OF DATA-INCLUDING SAMPLING PROCEDURE IF ANY
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS; IF SO PLEASE DESCRIBE BRIEFLY
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION FOR THE ABOVE / APPENDIX – II
APPENDIX – IIA
APPENDIX – IIB
APPENDIX – IIC
APPENDIX – IID
8. / LIST OF REFERENCES / APPENDIX – III
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE / Benign breast disease is a common problem presenting with pain with or without lump. Most often psychological with poor response to medical or surgical line of treatment, which requires reassurance especially, young ladies without lump. The proposed study is to exclude cancer-phobia, to advice routine health checkup, to find out type of benign breast disease, investigations, effective treatment and its response by follow-up.
11. / NAME AND DESIGNATION OF {IN BLOCK LETTERS}
11.1 NAME & DESIGNATION OF GUIDE / Dr. S.N. LINGE GOWDA M.B.B.S, M.S, FRCS (Edin)
PROFESSOR,
DEPARTMENT OF GENERAL SURGERY,
A.I.M.S, B.G.NAGARA.
11.2 SIGNATURE OF GUIDE
11.3 CO-GUIDE (IF ANY) / NO
11.4 SIGNATURE OF CO-GUIDE / NO
11.5 HEAD OF DEPARTMENT /
Dr. R. SRINATH M.B.B.S., M.S.,
PROFESSOR AND HEAD
DEPARTMENT OF GENERAL SURGERY,
A.I.M.S, B.G.NAGARA.
11.6 SIGNATURE
12 / 12.1 REMARKS OF THE CHAIRMAN & PRINCIPAL / The facilities required for the investigation will be made available by the college
Dr. SHIVARAMU. M.G., M.B.B.S., M.D.
PRINCIPAL,
AIMS, B.G. NAGARA.
12.2 SIGNATURE

APPENDIX - I

6. BRIEF RESUME OF INTENDED WORK

APPENDIX - IA

6.1 NEED FOR THE STUDY:

Breast is a dynamic structure, which undergoes changes throughout a woman’s reproductive life, and superimposed upon this, cyclical changes throughout the menstrual cycle. The pathogenesis of Benign Breast diseases involves disturbances in the breast physiology extending from an extreme of normality to well defined disease process.

Benign Breast disease is the most common cause of breast problems – upto 30 percent of women will suffer from a benign breast disorder requiring treatment at sometime in their lives.1

Approximately 40% of all patients attending a breast clinic have a benign breast lump. The main problem from a woman’s point of view is fear that such a lump may be cancer.2 The aim of treatment is to exclude cancer and once this has been done, to treat any remaining symptoms.

Benign breast disorders and diseases encompass a wide range of clinical and pathological entities. Surgeons require – in depth understanding of benign breast disorders so that clear explanation may be given to affected women, appropriate treatment instituted and unnecessary long term follow up avoided.3

APPENDIX - IIB

6.2 REVIEW OF LITERATURE

Astley Paston Cooper (1768-1841) surgeon, Guy’s Hospital, London, England was an important early worker to describe many aspects of benign breast disorders as well as malignant disease, in his monograph – “Illustration of diseases of the breast”, published in 1829.4

The French Surgeon, Reclus, gave an excellent description of clinical and pathological aspects of cystic diseases in 1893, recognizing both multiplicity and bilaterality of the cyst.4

Benjamin Collins Brodie (1783-1862) Surgeon, St. George’s Hospital, London, England, described cystosarcoma phyllodes or Serocystic disease of Brodie in 1840.1

Dr. Uma Krishnaswamy (2003), Department of Surgery Appollo Hospitals, Chennai in his cross-sectional analysis of 1786 Urban Indian Women undergoing routine health check-up found that 12.75% women had benign breast problems.5

A prospective Cohort study by Tariq Wahab Khanzada et al at Isra University Hospital, Hyderabad and two other private hospitals in Hyderabad, Pakistan showed that fibroadenoma was the most common benign breast disease seen in 27% of patients followed by fibrocystic disease in 21%. The conclusion was that benign breast disease are common problems in females of reproductive age. Fibroadenoma is the commonest and mostly seen in 2nd and 3rd decades of life. Fibrocysistic disease is the next common BBD whose incidence increases with increasing age.6

A study of profile of Breast lesions among women with positive biopsy findings by A.K. Al Thobhani et al (2006), Department of Surgery, University of Sana’a, Yemen showed that benign lesions were found in 79.9% of cases and Invasive Carcinoma in 20.1% of cases. Fibroadenoma was the most prevalent lesion (30%) with mean age of presentation of 22.2 years, followed by fibrocystic disease (27.4%) and breast inflammation (13.1%).7

A study of breast lump of 2246 cases by fine needle aspiration by Dr. Pradhan M, Pathology Clinic, Oslo, Norway between 2000-2004 found that out of 2246 cases, 1840 cases non-malignant out of which 43% was Fibrocystic, 8% fibroadenoma, 6% abscess and 4% fibrocystic changes.8

A study by Jorge Blanko.A et al of Severo OChoa Hospital, Madrid, Spain (1999) described the clinical, mammographic and Sonographic findings of phylloides tumors of breast and its clinical behaviour and correlated them to benign or malignant pathological nature. Only the histopathological features of the excised mass proved to be helpful in assessing malignancy.9

A study by Tewari M. et al, Department of Surgical Oncology, Institute of Medical Sciences, Varanasi (2005) found that the significance of breast tuberculosis is due to the mistaken identity with breast cancer and pyogenic breast abscess. Diagnosis is based on identification of typical histological features of tuberculosis bacilli under microscopy or culture.10

In 2009, Engwad et al studied 783 breast aspirates to determine whether FNAC or CNB should be used as the first preoperative diagnostic tool and recommended the use of FNAC as a first choice tool in triple diagnostics.

APPENDIX - IC

6.3 AIM OF THE STUDY:

To study the following features

  1. Types of benign breast diseases.
  2. The age of occurrence of different benign breast diseases.
  3. Modes of presentation and clinical features.
  4. Management, response to treatment and complications arising during follow-up.
  5. Correlation of clinical findings with FNAC, ultrasound and Histopathology.

APPENDIX - II

7. MATERIALS AND METHODS

APPENDIX - IIA

7.1 SOURCE OF DATA:

A clinical study of benign breast disease will be conducted at Sri Adichunchanagiri Hospital & Research Centre, B.G.Nagara attached to Sri Adichunchanagiri Institute of Medical sciences B.G.Nagara in the Department of Surgery.

Female patients above 12 years of age attending the OPD and also the patients admitted to the Department of Surgery with Clinical diagnosis of benign breast disease during the study period from Nov. 2013 to May 2015 will be taken up for the stud

APPENDIX - IIB

7.2 METHOD OF DATA COLLECTION:

Female patients above 12 years of age attending the OPD and those admitted to the Department of Surgery, Sri Adichunchanagiri Institute of Medical sciences B.G.Nagara will be interviewed as per the proforma to be designed for the study which includes clinical features, clinical findings, investigations, treatment and complications that may arise following treatment.

A minimum of 50 cases will be selected on random sampling basis.

INCLUSION CRITERIA :

  • Female patients above 12 years of age attending the OPD and those admitted in Department of Surgery, Sri Adichunchanagiri Institute of Medical sciences B.G.Nagara with clinical diagnosis of benign breast disease and who are willing to undergo investigations and treatment.
  • Patients willing for follow up on monthly basis for a total period of 12 months following excision or conservation management.

EXCLUSION CRITERIA :

  • Male patients
  • Cases of malignant breast lumps as per FNAC findings.
  • All patients aged 12 years and less.

APPENDIX - IIC

7.3 Does the study require any investigations or interventions to be conducted on patients or other animals; if so describe briefly:

YES

INVESTIGATIONS:

  • Routine investigations:
  • Hemoglobin percentage
  • Total count
  • Differential count
  • Erythrocyte sedimentation rate
  • Bleeding time
  • Clotting time
  • Urine for protein, sugar and microscopy
  • Random blood sugar
  • Blood urea
  • Serum creatinine
  • Specific investigations:
  • Fine needle aspiration cytology
  • Ultrasound
  • Excision biopsy
  • Mammography

1, 2 will be done in all the cases 3, 4 will be done in selected cases. No animal studies are conducted in this study.

APPENDIX – II D

7.4 PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION A
a / Title of the study / “A CLINICAL STUDY OF BENIGN BREAST DISEASES”
b / Principle investigator
(Name and Designation) / Dr. TEJUS V NAGI REDDY
NO. 74, KALPATARU BHAVAN,
A.I.M.S., B.G.NAGARA,
NAGAMANGALA TALUK,
MANDYA DISTRICT,
KARNATAKA-571448.
c / Co-investigator
(Name and Designation) / Dr. S.N. LINGE GOWDA
M.B.B.S, M.S, FRCS (Edin)
PROFESSOR,
DEPARTMENT OF GENERAL SURGERY,
A.I.M.S, B.G.NAGARA.
d / Name of the Collaborating
Department/Institutions / DEPARTMENT OF GENERAL SURGERY, A.I.M.S., B.G.NAGARA
e / Whether permission has been obtained from the heads of the collaborating departments & Institution / YES
Section – B
Summary of the Project / APPENDIX I
Section – C
Objectives of the study / APPENDIX IC
Section – D
Methodology / APPENDIX IIB
A / Where the proposed study will be undertaken / SAH & RC, B.G.NAGARA
B / Duration of the Project /
18 MONTHS
C / Nature of the subjects:
Does the study involve adult patients?
Does the study involve Children?
Does the study involve normal volunteers?
Does the study involve Psychiatric patients?
Does the study involve pregnant women? / YES
NO
NO
NO
NO
D / If the study involves health volunteers
  1. Will they be institute students?
  2. Will they be institute employees?
  3. Will they be Paid?
  4. If they are to be paid, how much per session?
/ NO
NA
NA
NA
E / Is the study a part of multi central trial? / NO
F / If yes, who is the coordinator?
(Name and Designation)
Has the trial been approved by the ethics Committee of the other centers?
If the study involves the use of drugs please indicate whether.
I. The drug is marketed in India for the indication in which it will be used in the study.
II. The drug is marketed in India but not for the indication in which it will be used in the study
III. The drug is only used for experimental use in humans.
IV. Clearance of the drugs controller of India has been obtained for:
Use of the drug in healthy volunteers
Use of the drug in-patients for a new indication.
Phase one and two clinical trials
Experimental use in-patients and healthy volunteers. / NA
NA
NA
NA
NA
NA
NA
NA
G / How do you propose to obtain the drug to be used in the study?
-Gift from a drug company
-Hospital supplies
-Patients will be asked to purchase
-Other sources (Explain) / NA
H / Funding (If any) for the project please state
-None
-Amount
-Source
-To whom payable / NIL
I / Does any agency have a vested interest in the out come of the Project? / NO
J / Will data relating to subjects /controls be stored in a computer? / NO
K / Will the data analysis be done by
-The researcher?
-The funding agent / YES
NO
L / Will technical / nursing help be required form the staff of hospital.
If yes, will it interfere with their duties?
Will you recruit other staff for the duration of the study?
If Yes give details of
  1. Designation
  2. Qualification
  3. Number
  4. Duration of Employment
/ NO
NA
NA
NA
M / Will informed consent be taken? If yes
Will it be written informed consent:
Will it be oral consent? Will it be taken from the subject themselves?
Will it be from the legal guardian? If no, give reason: / NO
NA
NA
NA
NA
N / Describe design, Methodology and techniques / APPENDIX II

Ethical clearance has been accorded.

Chairman,

P.G Training Cum-Research Institute,

A.I.M.S., B.G.Nagara.

Date :

PS : NA – Not Applicable

APPENDIX – III

8. LIST OF REFERENCES
  1. Sainsburg RC. The Breast. 24th edition. In : Russel RCG, Williams NS, Bullstrode CJK, Bailey and Love’s Short practice of surgery. London : Arnold Publishers 2004; 824-826.
  2. Greenhall MJ. Benign conditions of the breast. In. Morris PJ, Malt RA, Oxford textbook of surgery. New York. Oxford Medical Publication 1994; 789-808.
  3. Kirby I Bland, Samuel W. Beenken and Edward M. Copeland. The Breast. 8th Edition. In F. Charles Brunicardi et al. Schwartz’s Principles of Surgery. McGraw Hill Medical Publishing Division 2005; 463.
  4. Hughes LE, Mansel RE, Webster DJT. Benign disorders and disease of breast. Concepts and clinical management. 2nd edition. Bailliere Tindall. London : 1989.
  5. Krishnaswamy U. Profile of benign breast disorders and diseases in Urban India. Indian J Surgery 2003; 65 : 178-81.
  6. Tariq Wahab Khanzada, Abdul Samad, Champa Sushel. Spectrum of Benign breast diseases. Pakistan Journal of Medical Sciences 2009; 25(2): 265-268.
  7. Al-Thobhani AK, Raja YA, Noman TA, Al-Romaimah MA. Profile of Breast Lesions among women with positive biopsy findings in Yemen. Eastern Mediterranean Health Journal 2006; 12(5).
  8. Pradhan M, Dhakal HP. Study of Breast Lump of 2246 cases by Fine Needle aspiration. Journal of Nepal Medical education 2008; 47(172): 205-209.
  9. Jorge Blanco A et al. Phylloides tumours of the breast 1999; (9(2): 356-60.
  10. Tewari M. Shukla MS. Institute of Medical Sciences Varanasi, India. Breast Tuberculosis. Diagnosis Clinical features and management. Indian J Med 2005; 122 (2): 103-10.

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