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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BENGALURU, KARNATAKA
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1
Name of the candidate and address
(in block letters)
2
Name of the Institution
3
Course of the study and subject
M.S. OBSTETRICS AND GYNAECOLOGY
(3 YEARS DURATION)
4
Date of admission to course
22nd APRIL 2011
5
Title of the topic
Dr. SRIPRIYA MOHAN
VYDEHI INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH CENTRE
BANGALORE - 66
VYDEHI INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH CENTRE
BANGALORE - 66
Comparative study of Papanicolaou
Smear and Colposcopy in the
evaluation of cervical lesions.
6
Brief resume of the intended work
6.1 Need for the study
Cancer cervix continues to be the most common genital cancer encountered
in India accounting for 80% of all female genital cancers.[1] More so, in
relevance to our set up where the rural population is dominant.The average
annual crude and age-standardised incidence rate (ASR) of cancer of the
cervix in Bangalore for the period 1992-99 was 18.6 and 28.8 per 100,000
respectively.The average annual crude and age-adjusted death rate for the
period were 8.2 and 13.3 per 100,000 respectively, giving a mortality
incidence ratio of 0.46.[2]
The concept pre-invasive disease of cervix or Cervical intraepithelial
neoplasia(CIN) denotes changes that are confined to the cervical epithelial
cells. Early detection and treatment of CIN has the potential to improve the
outcome of treatment.Invasive cancer of cervix is considered to be a
preventable condition, since it is associated with a long pre-invasive stage
(CIN), making it amenable to screening and treatment.[3]
CIN may be identified by microscopic examination of cervical cells in a
cytology smear stained by the Papanicolaou technique. In cytological
preparations, individual cell changes are assessed for the diagnosis of CIN
and its grading. In contrast, histological examination of whole tissues allows
several other features to be examined.[3]
Nuclear enlargement with variation in size and shape is a regular feature of
all dysplastic cells. Increased intensity of staining (hyperchromasia) is
another prominent feature. Irregular chromatin distribution with clumping is
always present in dysplastic cells. Mitotic figures and visible nucleoli are
uncommon in cytological smears. Abnormal nuclei in superficial or
intermediate cells indicate a low-grade CIN, whereas abnormality in nuclei of
parabasal and basal cells indicates high-grade CIN. The amount of
cytoplasm in relation to the size of the nucleus (nuclear-cytoplasmic ratio) is
one of the most important base for assessing the grade of CIN. Increased
ratios are associated with more severe degrees of CIN. Final diagnosis of
CIN is established by the histopathological examination of a cervical punch
biopsy or excision specimen. A judgement of whether or not a cervical tissue
specimen reveals CIN, and to what degree, is dependent on the histological
features concerned with differentiation, maturation and stratification of cells
and nuclear abnormalities. The proportion of the thickness of the epithelium
showing mature and differentiated cells is used for grading CIN. More severe
degrees of CIN are likely to have a greater proportion of the thickness of
epithelium composed of undifferentiated cells, with only a narrow layer of
mature, differentiated cells on the surface.[3]
6.2 Review of literature
Cancer of the cervix is a major health problem in India, which accounts for
26.1—43.8% of all cancers in Indian women.[3] Therefore, screening and
early detection of precancerous lesions is a priority in our country.
The Papanicolaou (Pap) smear has been recognized widely as the most
effective cancer screening test in history of medicine. Pap smear introduced
by George Papanicoloau into clinical practice circa 1940 is the primary
screening tool for cervical intraepithelial neoplasia (CIN) and invasive cancer
of the uterine cervix. Use of the Pap smear has reduced morbidity and
mortality from invasive cancer in various population groups.[4] Recently, the
assumed accuracy of the Pap smear, 80 to 95% for detecting CIN and early
invasive cancer, has been questioned. Conversely, a false negative rate of
the Pap smear has been reported under carefully controlled condition.The
simultaneous use of cytological studies and screening colposcopy has been
shown to increase cervical cancer detection.[5]
Colposcopy means to look into the vagina (ie, colpo means vagina, scope
means to look). It was first described by Hans Hinselman of Germany in
1925. It is performed using a colposcope, an optical instrument that supplies
magnification (typically 5-25X) and often records photographs. Magnification
provided by colposcope is 6-40 times. Blue/green filter is used for
visualization of vascular pattern, as they appear dark and visibly contrasted
against the surrounding epithelium.The false negative rate was significantly
lower for colposcopy (1.92%) as compared to that for the Papanicolau
smear (17.98%).[6]
Visual inspection with acetic acid (VIA) involves swabbing the cervix with a
5% acetic acid solution prior to visual examination. Due to differences in
precancerous cell structure and opacity, abnormal cells temporarily appear
white when exposed to this solution. Immediately after VIA, the Lugol’s
iodine solution is applied over the cervix, areas of healthy tissues will stain
brown (mahagony brown) while areas of abnormal cells would turn white or
yellow. In case of immature squamous metaplasia, there will be a partial
iodine uptake.[7] The application of iodine or acetic acid highlights the area
with abnormalities and enables the clinician to take biopsies in the affected
area of the cervical epithelium.
6.3 Objectives of the study
1. To compare the efficacy of PAP Smear and Colposcopy.
2.To critically evaluate the sensitivity and specificity of Colposcopy versus
pap smear in the early detection of dysplasias
7
Materials and Methods
7.1 Source of data
The study will be conducted on 100 women attending Gynaecology OPD
and fitting into the inclusion criteria in the Department of Obstetrics and
Gynaecology at Vydehi Institute of Medical Sciences & Research Centre,
Bangalore, from January 2012 to December 2012.
7.2 Method of collection of data (including sampling procedure if
any)
This is a cross sectional study.
A pre structured proforma will be used to obtain:
1. Written informed consent and counselling
2. Detailed history
3. Clinical examination
4. Investigations
Sample Size:100 women fitting into the inclusion criteria will be
selected.
INCLUSION CRITERIA:
1. Age : 20-60 years
2. Patients with abnormal symptoms like profuse white discharge, post coital
bleeding, intermenstrual bleeding or post menopausal bleeding.
3. Patients with clinically unhealthy cervix diagnosed by speculum
examination like, cervical erosion, cervicovaginitis, cervical polyp,
condylomas etc.
EXCLUSION CRITERIA:
1. Patients with bleeding at the time of examination.
2. Women with frank invasive cancer.
3. Pregnant women.
Methodology:
Basic steps of examination include:
1. Written informed consent and counselling
2. Detailed history
3. Physical examination
4. Local examination of vulva
5. Speculum examination of cervix and vagina
6. Pap smear – Conventional method using Ayre’s spatula and fixed using
95% Alcohol
7. Colposcopic evaluation
8. Inspection of cervix after application of 5% acetic acid
9.Examination through green filter
10.Staining the cervix with Lugol’s iodine
11.Colposcope directed biopsy using a punch biopsy forceps if indicated.
Statistical analysis: Data will be analysed using ,

Chi square test to analyse the efficacy of PAP smear &
colposcopy.

Sensitivity and Specificity of PAP smear & colposcopy.
7.3 Does the study require any investigations or interventions to be
conducted on patients or other humans or animal? If so, please
describe briefly.
YES
The investigations done in the cases selected for the study are :

Colposcopic evalution

Pap smear

Biopsy
7.4 Has ethical clearance been obtained from your institution in case
of 7.3
YES
8
References
1. Padubidri VG, Daftary SN. Shaws Textbook of Gynecol 13th ed page 383384
2. Nandakumar A, Anantha N and Thimmastfiy K. (2001).Cancer Patterns in
Bangalore, India 1992-99. Population Based Cancer Registry of Bangalore.
Kidwai Memorial Institute of Oncology: Bangalore, India. BJC(2007) 96,
11071111.doi:10.1038/sj.bjc.6603679 www.bjcancer.com Published online
6 March 2007
3.Miller AB, Nazeer S, Fonn S. Report on Consensus Conference on
Cervical Cancer Screening and Management. Int J Cancer 2000;86:440–7
4. Cronje HS, Parham GP, Cooreman BF, de Beer A, Divall P and Bam RH: A
comparison of four screening methods for cervical neoplasia in a developing
country. Am J Obstet Gynecol 188(2): 395-400, 2003.
5.Sankaranarayanan R, Nene BM, Dinshaw K. Early detection of cervical
cancer: a summary of completed and on-going studies in India. Salud
Publica Mex 2003;45:S399–407
6. Syrjanen K, Naud P, Derchain SM, Roteli-Martins C, Longatto- Filho A:
Comparing PAP smear cytology, aided visual inspection (VIA), screening
colposcopy, cervicography and HPV testing by HCII (normal and selfsampling) as optional screening tools in Latin America. Experience from the
LAMS study. In: Monsonego J(ed.). 5th International Multidisciplinary
Congress EUROGIN 2003. Monduzi Editore, Milano pp. 65-73, 2003.
7.Singh V, Sehgal A, Parashari A, Sodhani P, Satyanarayana L. early
detection of cervical cancer through acetic acid application: An aided visual
inspection. Singapore Med J 2002 Aug; 42(8): 351-4.
9
Signature of the candidate
10 Remarks of the guide:
FEASABLE AND RECOMMENDED
11 Name and designation of the
guide (in block letters)
11.1 Guide
Dr. SHREEDHAR VENKATESH
PROFESSOR & HOD
DEPARTMENT OF OBSTETRICSAND
GYNAECOLOGY
VYDEHI INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH CENTRE,
BANGALORE.
11.2 Signature
11.3 Head of the Department
11.4 Signature
12 12.1 Remarks of the Principal
12.2 Signature
Dr. SHREEDHAR VENKATESH
PROFESSOR & HOD
DEPARTMENT OF OBSTETRICSAND
GYNAECOLOGY
VYDEHI INSTITUTE OF MEDICAL
SCIENCES AND RESEARCH CENTRE,
BANGALORE.