Rajiv Gandhi University of Health Sciences, Karnataka s17

From, Date: 15.11.2011 Dr.Chandana.N, Place: Bellary PG Student in MS (Obstetrics & Gynecology), Department of OBG, Vijayanagar Institute of Medical Sciences, Bellary.

To, The Principal, Vijayanagar Institute of Medical Sciences, Bellary.

Through Proper Channel

Respected Sir,

Subject : “Submission and forwarding of Synopsis for Registration of Dissertation Topic.”

In accordance with the below cited topic, I, the undersigned studying in PG course in MS OBG has been allotted the dissertation topic : “DIAGNOSTIC ACCURACY OF INTRA-OPERATIVE IMPRINT CYTOLOGY IN OVARIAN TUMOURS” under the guidance of Dr.Chandrashekhar.T , Associate Professor, Department of OBG, VIMS, Bellary.

I am requesting you to forward the dissertation topic in the prescribed form to the Registrar, Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka for approval. Thanking you,

Yours faithfully,

(Dr.Chandana.N.)

Signature of the guide , Signature of the HOD,

Dr.Chandrashekhar.T, Dr. A.A. Khazi Associate Professor, Professor & HOD Department of OBG, Department of OBG, VIMS, Bellary. VIMS, Bellary From, Place: Bellary Professor and Head of the Department, Date:15.11.11 Department of Obstetrics and Gynaecology, VIMS, Bellary. To , The Registrar, Rajiv Gandhi University of Health Sciences, Bangalore. THROUGH PROPER CHANNEL Respected Sir, As per the regulations of the University for registration of Dissertation topic, the following Post Graduate Student in MS-Obstetrics and Gynaecology has been allotted the dissertation topic as follows by the Official Registration Committee of all qualified and eligible guides of the Department of Obstetrics and Gynaecology. NAME TOPIC GUIDE DR. CHANDANA.N “DIAGNOSTIC DR.CHANDRASHEKHAR.T Post Graduate Student in M.S. ACCURACY OF INTRA- Associate Professor , Dept. of Obstetrics and OPERATIVE IMPRINT Department of Obstetrics and Gynaecology, CYTOLOGY IN OVARIAN Gynaecology, VIMS, Bellary. TUMOURS” VIMS, Bellary.

Therefore, I kindly request you to communicate the acceptance of the dissertation topic allotted to the PG student at an early date. Thanking you, Yours faithfully,

(DR.CHANDRASHEKHAR.T) Associate Professor , Department of Obstetrics and Gynaecology, VIMS, BELLARY. ,

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,BANGALORE, KARNATAKA

ANNEXURE II

SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 Name of the candidate And Address(in DR.CHANDANA.N. block letter) POSTGRADUATE STUDENT IN M.S. OBSTETRICS AND GYNAECOLOGY, VIMS, BELLARY-583104

2 Name of the institution Vijayanagara Institute of Medical Sciences,Bellary- 583104

3 Course of study and subject Medical M.S.in OBSTETRICS AND GYNAECOLOGY. 4 Date of admission to course 30.06.2011

5 Title of the topic: “DIAGNOSTIC ACCURACY OF INTRA-OPERATIVE IMPRINT CYTOLOGY IN OVARIAN TUMOURS” 6 6.1 BRIEF RESUME OF THE INTENDED WORK

Of all the gynecological cancers, ovarian malignancies represents greatest clinical challenge. It accounts for 15 to20 %of all genital malignancy . Most of the ovarian tumors cannot be easily distinguished from one another on the basis of their clinical or gross alone.Therefore, cytological interpretation of ovarian neoplasms is both interesting and challenging.

It may not be possible to determine before surgery whether patients presenting with ovarian or adnexal masses have benign or malignant disease. Clinical, serological, and radiological findings are not completely specific and even the intra operative findings may be misleading1,3.

Although advanced stage ovarian carcinoma has characteristic macroscopic appearances, occasionally these are mimicked by high-stage borderline (proliferating) tumors, disseminated malignancies of non gynecological origin, and even by inflammatory processes. Assessing the nature of tumors confined to the ovaries is even more problematic because benign and malignant neoplasm can have identical gross appearances4,5.

As the optimal management of benign, borderline, and malignant ovarian tumors differs, especially in patients who wish to retain fertility ,intra operative assessment frequently is used to provide a provisional pathological diagnosis and to guide the extent of surgery and/or the requirement for additional staging procedures7,8.

Cytological techniques have also been used for many years in the intra operative situation either as an alternative or, more commonly, a complement to frozen section diagnosis, and several studies have demonstrated that cytological assessment has similar accuracy to frozen section in a wide variety of tumor types5,6

The aims of the present study, therefore is to further assess the overall accuracy of intra operative diagnosis of ovarian tumors by imprint cytology technique and to compare those cases with histopathological diagnosis , and to determine whether the addition of cytology preparations provides useful information in the intra operative setting8. 6.2 Review of literature: Diagnostic cytology is the science of interpretation of cells that are either exfoliated from epithelial surfaces or removed from various tissues. George N Papanicolou introduced cytology as a tool to detect cancer and pre-cancer in 19281,2.

The use of frozen sections for intraoperative tissue diagnosis is a well-accepted procedure (Ackerman and Ramirez, 1959; Nakazawa et al., 1968; Shivas and Fraser, 1971; Holaday and Assor, 1974)1.

Another method is the examination of imprints of fresh specimens. This technique was favourably reported by Dudgeon and Patrick (1927) and Bamforth and Osborn (1958), but not until recently has it achieved the recognition it deserves in the English literature (Pickren and Burke, 1963; Tribe, 1965; Godwin, 1968; Silverberg, 1975; Suen et al., 1976; Godwin, 1976).3

Amitha Maheshwari et al in 2006 reported Intraoperative frozen section has high accuracy in the diagnosis of suspected ovarian neoplasms. It is a valuable tool to guide the surgical management of these patients and should be routinely used in all major oncology centers.5

Colin J. R. Stewart et al in 2010 reported frozen section proved more accurate than smear preparations in the intraoperative assessment of ovarian tumors in this study. However, the cytology preparations were helpful in supporting the histological diagnoses, and in some cases, provided additional useful information. Thus, cytology has a complementary role to frozen section in the intraoperative assessment of ovarian lesions.3

6.3 Objectives of Study

▸ To establish the validity and reliability of imprint cytology and its accuracy in intra operative diagnosis of ovarian tumours.

▸ To compare it with the final histopathology reports.

7) MATERIALS AND METHODS 7.1 ▸ SOURCE OF DATA: Study will be conducted on patients undergoing surgery for ovarian tumours in OBG Department,VIMS, Bellary during period of 2 years. ▸ STUDY DESIGN: Prospective study ▸ STUDY SETTING : Department of Obstetrics and Gynaecology, Vijayanagara Institute of Medical Sciences, Bellary. ▸ STUDY PERIOD :November 2011 TO October 2013 (24 months).

INCLUSION CRITERIA : 1) All patients undergoing surgery for ovarian tumours.

2) Tumors that may have arisen within the fallopian tubes but were associated with dominant ovarian masses.

EXCLUSION CRITERIA : 1) Patients who had taken radiotherapy. 2 ) suspicious inflammatory ovarian masses. 3) Functional ovarian cysts.

7.2 Method of collection of data ( including the sampling procedure if any) The study will be conducted in the Department of Obstetrics and Gynaecology, Medical college hospital ,VIMS ,Bellary for a period of 2 years from Nov 2011 TO Oct 2013. METHOD OF DATA COLLECTION :

In this prospective study, materials are obtained from patients undergoing surgery for ovarian tumours. Detailed clinical history, physical examination and investigations will be recorded. Intra-operatively multiple imprint smears will be taken from resected tumor masses. Imprint cytology report will be received within 20 min of smear preparation .Further line of management will be decided on table based on the imprint cytology report.. After completion of the surgery, the resected masses will be sent for histopathological study. Results of imprint cytology and histopathology will be compared and diagnostic accuracy of intra-operative imprint cytology evaluated.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.

Yes, the study requires the following routine investigations like complete heamogram, blood group& Rh type, investigations for surgical fitness(blood urea , serum creatinine, RBS, TC,DC, ESR, ECG, Chest X-ray) and special investigations like Ultrasonological examination, CA 125. CT scan done if necessary. All investigations are done under the guidance and supervision of our guide.. Before starting the study all patients included in our study will be supplied with patient information sheet and written/informed consent are obtained from each patient in local language.

7.4 Has the ethical clearance been obtained from your institution in case of 7.3?

Yes, ethical clearance has been obtained from the VIMS Institutional Ethical Committee (IEC),VIMS , Bellary. 8 )LIST OF REFERENCES:

1) . K.C.Suen, W.S.Wood, A.A.Syed, N.F.Quenville, P.B.Clement . “Role of imprint cytology in intraoperative diagnosis:value and limitations” J clinical pathology 1978;31:328-337.

2) Kar tushar, Kar Asaranti, Mahapatra PC .“Intra operative cytology of ovarian tumors” J Obstet Gynecol 2005;55(4):345-349.

3) Colin J.R.Stewart, Barbara A Brennan , Eleanor Koay , Anup Naran. “ Value of cytology in the intra operative assessment of ovarian tumors A review of 402 cases and comparison with frozen section diagnosis” J Cancer Cytology 2010;118:127-36.

4) K.Pavlakis ,I.Messini, T.Vrekoussis, P.Yiannou .“ Intra operative assessment of epithelial and non epithelial ovarian tumors: a 7- year review” J of Gynaeco Oncology 2009;XXX:657-660.

5) Amitha Maheshwari, Sudeep Gupta , Shubhada Kane , Yogesh Kulakarni .“ Accuracy of intra operative frozen section in the diagnosis of ovarian neoplasms” J of Surgical Oncology 2006;4: 1477.

6) Baker P , Oliva E .“ A Practical approach to intra operative consultation in gynaecological pathology” J Gynaeco Patholgy 2008;27:353-365.

7) Kim K, Philips ER, Poolino .“ Intra operative imprint cytology : its significance as a diagnostic adjunct” J Diagn Cytopathol. 1990;6:304-307.

8) Coffey , Kaplan AL, Ramzy I .“Intra operative consultation in gynaecologic pathology” J Arch Pathol 2005;129:1544-1547.

9)Berek SJ, Sathima Natarajan.Ovarian and fallopian tube cancer. Berek & novak’s Gynecology 14th ed Lippincott, Williams, Wilkins.2007;35:1457-1549.

10)John OS,Joseph IS,Lisa MH,Barbara LH,Karen DB,Gary FC. Epithelial Ovarian Cancer. Williams Gynecology .Mc Graw Hill.2008;35:716-738. 9. Signature of candidate:

10. Remarks of guide:

11. Name & Designation : (in block letters)

11.1 Guide Dr. CHANDRASHEKHAR.T Associate Professor, Department of Obstetrics and Gynaecology, VIMS, Bellary.

11.2 Signature of guide

11.3 Co-guide Dr. GOVINDARAJA.E MS, M.Ch (Surgical oncology), Associate Professor, Department of Surgery, VIMS, Bellary. 11.4 Signature

11.5 Head of the department Dr. A.A.KHAZI Professor and Head of the Department , Department of OBG , VIMS, Bellary.

11.6 Signature

12. 12.1 Remarks of chairman & Principal

12.2 Signature