Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s28

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

Synopsis of Dissertation

“A HISTOPATHOLOGICAL STUDY OF OVARIAN LESIONS”

Submitted by Dr. ASHOK. K. P. M.B.B.S. POST GRADUATE DEGREE STUDENT IN PATHOLOGY (M.D.)

Under the guidance of Dr. M.C. RAGHUPATI B.Sc., M.B.B.S., DCP.,M.D., PROFESSOR DEPARTMENT OF PATHOLOGY A.I.M.S., B.G.NAGARA-571448.

DEPARTMENT OF PATHOLOGY ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES, B.G.NAGARA-571448 2 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE & Dr. ASHOK. K. P. ADDRESS DEPARTMENT OF PATHOLOGY A.I.M.S., B.G.NAGARA, NAGAMANGALA TALUK, MANDYA DISTRICT-571448.

ADICHUNCHANAGIRI INSTITUTE OF 2. NAME OF THE INSTITUTION MEDICAL SCIENCES, B.G.NAGARA

3. COURSE OF STUDY & SUBJECT M.D. IN PATHOLOGY

4. DATE OF ADMISSION TO COURSE 7TH AUGUST 2013

“A HISTOPATHOLOGICAL STUDY OF 5. TITLE OF THE DISSERTATION OVARIAN LESIONS”

6. BRIEF RESUME OF INTENDED WORK APPENDIX – I 6.1 NEED FOR THE STUDY APPENDIX – IA 6.2 REVIEW OF LITERATURE APPENDIX – IB 6.3 OBJECTIVES OF THE STUDY APPENDIX – IC

7. MATERIALS AND METHODS APPENDIX – II

7.1 SOURCE OF DATA: APPENDIX – IIA

7.2 METHOD OF COLLECTION OF APPENDIX – IIB DATA: (INCLUDING SAMPLING PROCEDURE IF ANY)

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS APPENDIX – IIC TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.

7.4 HAS ETHICAL CLEARANCE BEEN YES OBTAINED FROM YOUR APPENDIX – IID INSTITUTION IN CASE OF 7.3. 8. LIST OF REFERENCES APPENDIX – III

3 9. SIGNATURE OF THE CANDIDATE

10. REMARKS OF THE GUIDE

11. 11.1 NAME AND DESIGNATION OF Dr. M.C. RAGHUPATHI, GUIDE B.Sc., M.B.B.S., DCP, M.D., PROFESSOR DEPARTMENT OF PATHOLOGY AIMS, B.G. NAGARA-571448

11.2 SIGNATURE

11.3 CO- GUIDE (IF ANY) NO

11.4 SIGNATURE NO

11.5 HEAD OF THE DEPARTMENT Dr. Y. H. KALEGOWDA. MBBS, DCP, MD PROFESSOR AND HEAD DEPARTMENT OF PATHOLOGY AIMS, B.G. NAGARA-571448

11.6 SIGNATURE

12. 12.1 REMARKS OF THE CHAIRMAN The facilities required for the investigation AND PRINCIPAL will be made available by the college

Dr. M.G SHIVARAMU M.B.B.S., MD PRINCIPAL, AIMS, B.G. NAGARA.

12.2 SIGNATURE

4 APPENDIX-I

6. BRIEF RESUME OF THE INTENDED WORK:

APPENDIX-IA

6.1 NEED FOR THE STUDY

Though ovaries are remarkably resistant to disease, tumors of the ovary are common and form the third most common tumors of female genital tract i.e., next to carcinoma cervix and endometrium. As majority of tumors pose forbidable clinical challenges because they produce no signs and symptoms initially, a histopathological study of all the ovarian lesions is a must for a final diagnosis, so this study is taken up now as the same has not been carried out in our department in the past.

APPENDIX –I B

6.2 REVIEW OF LITERATURE:

Makwana H et al in their study reported that maximum incidence of ovarian masses was between 21 to 40 years of age. Non-neoplastic lesions constituted to 58.46% and neoplastic lesions constituted to 41.54%. Among neoplastic 32.05% were benign, 1.48% borderline and 8.01% malignant1.

Kuladeepa AVK et al concluded in their study that a macroscopic and microscopic feature of ovarian tumors enables categorization into exact morphological type which helps

Gynecologist for proper management. In their study of 134 ovarian tumors 82.35% were benign, 3.68% borderline and 13.97% malignant2.

Tung KH et al reported that ovulatory factors, including lifetime ovulatory cycles and longer duration of breastfeeding, menstrual irregularity, and tubal ligation, were associated with risk of nonmucinous tumors but not of mucinous tumors. There appears to be a histologic link between borderline and malignant tumors, since they share common risk

5 factors. Complex mechanisms in conjunction with ovulation, hormones, inflammation, and molecular pathways may all be involved in the pathogenesis of ovarian cancer3.

Mondal SK et al in their study noted that among 957 cases of ovarian tumors benign tumors occurred between 20 to 40 years of age, while malignant between 41 to 50 years and regarding bilateral involvement of ovaries metastatic tumors were found to involve 72%, malignant serous tumors 45.5%, borderline serous tumors 27.4% and borderline mucinous tumors 15.7%4.

Ashraf A et al reported that neoplastic lesions are common than non neoplastic.

Among the non–neoplastic lesions luteal cyst was the predominant category followed by simple serous cyst. Among neoplastic lesions surface epithelial tumors were the most common followed by germ cell tumors. The commonest benign tumor was dermoid cyst and commonest malignant tumor was serous cystadenocarcinoma5.

Pradhan A et al in their study have pointed out that ovarian malignancies occur at all ages as it was evident from the occurrence of primary malignant ovarian tumors and metastatic tumors in younger age groups6.

Phukan JP et al in their study of ovarian tumors in perimenopausal women have reported that benign tumors accounted for 53.8%, malignant ovarian tumors 43.2% and borderline tumors 3.8%, majority of benign tumors were cystic (82.1%), while a minor proportion of malignant tumors were cystic (9.1%) on palpation7.

Alam S et al in their study of 150 non–neoplastic lesions of ovary, have found that the most common non-neoplastic lesions in oophorectomy specimens were corpus luteal cysts and endometriosis. Follicular cysts, inflammation and infarction were relatively less common findings in the order of frequency8.

6 APPENDIX-IC

6.3 OBJECTIVES OF THE STUDY

1. To find the incidence of non-neoplastic and neoplastic lesions of the ovary with

respect to age, reproductive period, pregnancy, parity, use of oral contraceptives and

whether unilateral or bilateral.

2. To make a histopathological diagnosis of the nature of the non neoplastic lesion and

in case of neoplastic lesions their origin, and benign or malignant nature.

3. To assess the prognosis in case of malignant lesions by considering the microscopic

grading.

7 APPENDIX-II

7. MATERIALS AND METHODS:

APPENDIX-II A

7.1 SOURCE OF DATA

All surgically resected ovarian specimens received at the Department of Pathology,

Adichunchanagiri Institute of Medical sciences, B.G. Nagara from all the units Obstetrics and

Gynaecology Department, Adichunchanagiri Institute of Medical sciences, B.G. Nagara and also from other peripheral hospitals.

APPENDIX-II B

7.2 METHOD OF COLLECTION OF DATA

. By recording a detailed clinical history, clinical examination findings and relevant

investigations carried out in a detailed proforma over a period of 18 months.

. Sample size about 125-150 ovarian masses/oophorectomy specimens to be subjected for

histopathological examination.

. Fixative to be used for histopathological examination is 10% formalin and stain to be

used is routine H&E stain and special stains like PAS, mucin carmine etc wherever

necessary.

INCLUSION CRITERIA

. All ovarian lesions will be included in the study.

EXCLUSION CRITERIA

. To exclude all associated lesions of the uterine cervix and fallopian tube from this study.

8 APPENDIX-II C

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS

TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS; IF SO PLEASE

DESCRIBE BRIEFLY.

. Hysterectomy/oophorectomy to be performed by the gynaec surgeon.

APPENDIX-II D

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION

IN CASE OF 7.3?

YES [PROFORMA ENCLOSED]

9 PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION A

“A HISTOPATHOLOGICAL STUDY OF a Title of the study OVARIAN LESIONS”

Dr. ASHOK. K. P. DEPARTMENT OF PATHOLOGY Principle investigator b A.I.M.S., B.G.NAGARA, (Name and Designation) NAGAMANGALA TALUK, MANDYA DISTRICT-571448.

Dr. M.C. RAGHUPATHI, B.Sc., M.B.B.S., DCP, M.D., Co-investigator c (Name and Designation) PROFESSOR DEPARTMENT OF PATHOLOGY AIMS, B.G. NAGARA-571448

Name of the Collaborating DEPARTMENT OF MEDICAL EDUCATION & d Department/Institutions DEPARTMENT OF O.B.G. Whether permission has been obtained from e the heads of the collaborating departments YES & Institution Section – B APPENDIX I Summary of the Project Section – C APPENDIX IC Objectives of the study Section – D APPENDIX IIB Methodology Where the proposed study will be ADICHUNCHANAGIRI HOSPITAL AND A undertaken RESEARCH CENTRE, B.G. NAGARA B Duration of the Project 18 MONTHS C Nature of the subjects: Does the study involve adult patients? YES Does the study involve Children? NO Does the study involve normal volunteers? NO Does the study involve Psychiatric patients? NO Does the study involve pregnant women? NO

D If the study involves health volunteers NO

10 I. Will they be institute students? NO II. Will they be institute employees? NO III. Will they be paid? NO IV. If they are to be paid, how much per NA session?

E Is the study a part of multi central trial? NO

F If yes, who is the coordinator? (Name and Designation) NA

Has the trial been approved by the ethics NA 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. NA 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.

11 G How do you propose to obtain the drug to be used in the study? - Gift from a drug company NA - Hospital supplies - Patients will be asked to purchase - Other sources (Explain) H Funding (If any) for the project please state - None - Amount NO - Source - To whom payable Does any agency have a vested interest in I NO the out come of the Project? Will data relating to subjects /controls be J YES stored in a computer? Will the data analysis be done by K - The researcher? YES - The funding agent NO L Will technical / nursing help be required from the staff of hospital. NO

If yes, will it interfere with their duties? NO

Will you recruit other staff for the duration of the study?

If Yes give details of NA I. Designation NA II. Qualification NA III. Number NA IV. Duration of Employment

12 M Will informed consent be taken? If yes NO Will it be written informed consent: NO Will it be oral consent? NO Will it be taken from the subject themselves? NO Will it be from the legal guardian? NO If no, give reason: NO

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 :

PG Training-cum research committee

13 APPENDIX-III

LIST OF REFERENCES

1. Makwana H, Maru A, Lakum N, Agnihotri A, Trivedi N, Joshi J. The relative

frequency and histopathological pattern of ovarian masses – 11 year study at tertiary

care centre. International Journal of Medical Science and Public Health. 2014; 3(1):

80-83.

2. Kuladeepa AVK, Muddegowda PH, Lingegowda JB, Doddikoppad MM, Basavaraja

PK, Hiremath SS. Histomorphological study of 134 primary ovarian tumors. Advance

Laboratory Medicine International 2011; 1(4): 69-82.

3. Tung KH, Goodman MT, Wu AH, Mcduffie K, Wilkens LR, Kolonel LN, Nomura

AMY, Terada KY, Carney ME, and Sobin LH. Reproductive factors and epithelial

ovarian cancer risk by histologic type:a multiethnic case-control study. Am J

Epidemiol 2003; 158: 629–638.

4. Mondal SK, Banyopadhyay R, Nag DR, Chowdhury SR, Mondal PK, Sinha SK.

Histologic pattern, bilaterality and clinical evaluation of 957 ovarian neoplasms: A

10-year study in a tertiary hospital of eastern India. Journal of Cancer Research and

Therapeutics. 2011 Oct-Dec; 7(4): 433-437.

5. Ashraf A, Shaikh A S, Ishfaq A, Akram A, Kamal F and Ahmad N. The relative

frequency and histopathological pattern of ovarian masses. Biomedica. Jan.-Jun.

2012; 28: 98-102.

6. Pradhan A, Sinha A, Upreti D. Histopathological patterns of ovarian tumors at

BPKIHS. Health Renaissance [Internet]. [cited 2012 Jul 10]. Available

from:http://www.nepjol.info/index.php/HREN/article/view/6570

7. Phukan J P, Sinha A, Sardar R, Guha P. Clinicopathological analysis of ovarian

tumors in perimenopausal women: A study in a rural teaching hospital of eastern

India. Bangladesh Journal of Medical Science. 2013 Jul; 12(3): 263-268

14 8. Alam S, Bhatti N. Pattern of Non Neoplastic Lesions of Ovary - A Study of 150

Cases. Ann. Pak. Inst. Med. Sci. 2010; 6(3): 156-159.