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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE,KARNATAKA.
PROFORMA FOR REGISTRATION OF DISSERTATION
TOPIC:
COMPARING THE EFFICACY OF VISUAL INSPECTION OF
CERVIX WITH ACETIC ACID(VIA) AND LUGOL’S IODINE(VILI)WITH PAP SMEAR
CYTOLOGY IN SCREENING FOR CANCER CERVIX IN
ASYMPTOMATIC WOMEN .
Dr .SNEHIL SINHA
POST GRADUATE
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
K.V.G MEDICAL COLLEGE,
SULLIA.
Rajiv Gandhi University of Health Sciences
Karnataka, Bangalore
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
NAME OF THE CANDIDATE AND
ADDRESS
Dr SNEHIL SINHA
POST GRADUATE STUDENT
DEPARTMENT OF OBSTETRICS AND
GYNAECOLOGY
K.V.G MEDICAL COLLEGE AND
HOSPITAL KURUNJIBHAG SULLIA –
574327
2.
NAME OF THE INSTITUTION
3.
COURSE OF STUDY AND SUBJECT
4.
DATE OF ADMISSION TO COURSE
K.V.G MEDICAL COLLEGE, SULLIA.
M.S OBSTETRICS & GYNAECOLOGY
5.
TITLE OF TOPIC
31-05-2011
COMPARING THE EFFICACY OF
VISUAL INSPECTION OF CERVIX WITH
ACETIC ACID(VIA) AND LUGOL’S
IODINE(VILI)WITH
PAP
SMEAR
CYTOLOGY
IN
SCREENING
FOR
CANCER CERVIX IN ASYMPTOMATIC
WOMEN
6
BRIEF RESUME OF THE INTENDED STUDY
6.1 Background and need of the study:
Of all the responsibilities of the gynaecologist in modern world perhaps none is as
important as the detection of the neoplasia at the earliest.Cancer cervix is the most
common cancer in the developing countries and second most common form of cancer in
women throughout the world.
Approximately 9710 new cases of invasive cervical cancer are diagnosed each
year.About 3700 deaths were anticipated in United States in 20061. 5 years survival rate
is 90% for localized cervical cancer and is considerably lower(14%)for persons with
advanced stage IV disease.
Although screening programs in the United States are well established,it is estimated that
30% of cervical cancer cases will occur in women who have never had a pap test.In
developing countries,this percentage approaches 60%.
This study aims at detecting the efficacy of visual inspection with acetic acid(VIA) and
lugols iodine(VILI) in the early detection of cancer cervix.The relative efficacy of these
two methods is compared with pap smear and cervical biopsy to choose an easily
interpretable low cost but equally effective method for early detection.
6.2 Review of literature:
1)In a study done by V Singh,A Sehgal,A Parashari,P Sodhani,L Satyanarayana to assess
the sensitivity and specificity of visual inspection of cervix for detection of pre cancerous
and early cancerous lesions of cervix they observed that screening for cervical pre
cancerous and cancerous lesions using visual inspection aided by acetic acid may be a
suitable low cost and a feasible alternative modality for control of cervical cancer in a
resource poor setting2.
2)In a study done by P.S.BASU et al observed that visual inspection of the cervix after
application of 3 to 5% acetic acid is a potential alternative to cytology for screening in
low resource countries3.
3)In three recent reviews of accuracy of cervical cytology assessment ,the sensitivity of
the pap test in detecting CIN 2-3 ranged from 47% to 62% and the specificity ranged
from 60% to 95%4.
4)Study conducted at the department of obstetrics and gynecology,Fatima Jinnah Medical
College,Lahore involving 501 women for comparison of visual inspection of cervix and
pap smear for cervical cancer screening.Of these 156 subjects were positive with
VIA(visual inspection with acetic acid)while pap smear was positive in 78 cases.The
accuracy of VIA was 77.5% compared to 52.8% PAP smear.They concluded that VIA
was more sensitive and highly specific.5
5)University of Zimbabwe/JHPIEGO cervical cancer project conducted a study in 1090
women to compare VIA with cytology.They concluded that VIA was highly sensitive
and could be valuable in detection of pre cancerous lesions of cervix but emphasis to
increase the specificity of VIA was made.6
6.3 Objectives of the study:
1)To compare the efficacy of visual inspection of cervix with acetic acid (VIA) and
lugol’s iodine(VILI) with Pap smear cytology in screening for cancer cervix in
asymptomatic women.
2)Early detection of pre cancerous conditions and treating them before they progress to
invasive cancer.
7-MATERIALS AND METHODS:
7.1 SOURCES OF DATA:
This study comprises of women who are sexually active , who come to gynaecology
out patient department with various complaints and those admitted to the gynaecology
ward.
PERIOD OF STUDY:1st of JANUARY 2012 31st OF DECEMBER 2012(1 year)
SETTING: Hospital based population.
DESIGN OF STUDY:prospective ongoing clinical study.
STATISTICAL TECHNIQUE USED:chi square test of significance.
7.2 Method of collection of data
Patients from the gynaecology out patient department and patients admitted in the
gynaecological wards will be screened for cancer cervix with visual inspection with
acetic acid ,lugols iodine and pap smear cytology.
SAMPLE SIZE: 200.
INCLUSION CRITERIA:
Non pregnant women.
Both nullipara and multipara.
Women accompanying the patients and those attending gynaecology department and
admitted in wards of gynaecology.
EXCLUSION CRITERIA:
Pregnant women.
Women during menstruation.
Women with intra vaginal medications.
Follow up –not applicable.
Follow up period –not applicable.
7.3 Does the study require any investigation/interventions to be conducted on
patients /human/ animals??
General physical examination:Clinical examination:
Per abdomen examination.
Per speculum examination:Taking of Pap smear followed by application of 3 to
5% acetic acid,followed by application of lugol’s iodine.
MATERIALS NEEDED:
Gloves, examination table, Sim’s double bladed posterior vaginal speculum, anterior
vaginal wall retractor, ayres spatula, lugol’s iodine,2 to 5 % acetic acid, swab, kopliks
jar, glass slides, pathology laboratory.
7.4 Has ethical committee clearance been obtained from your institution in case of
7.3?
YES- CLEARANCE COPIES ENCLOSED.
8
REFERENCES:
1.Jemal A, Tiwari RC, Murray T, et al. Cancer statistics, 2006.CA Cancer J Clin
2006;56:106-30.
2. Singh V, Sehgal A, Parashari A, Sodhani P, Satyanarayana L. Early detection of
cervical cancer through acetic acid application-An aided visual inspection. Sing Med J
2001;42(8):351-54.
3. Basu PS, Sankarnarayana R,Mandal R, Roy C, Das P,Choudhury D et al. Visual
inspection with acetic acid and cytology in the early detection of cervical neoplasia in
Kolkata,india. Int J Gynaecol Cancer2003;13:626-32.
4. Fahey MT, Irwig L, Macaskill P. Meta-analysis of Pap test accuracy. Am J Epidemiol
1995;141:680-89.
5.Tayyeb R, Khawaja NP,Malik N. Comparison of visual inspection of cervix and Pap
smear for cervical screening. J Coll Physicians Surg Pak 2003 ;13(4):201-03.
6.Chirenie ZM, Chipato T, Kasule J, Rusakaniko S.Visual inspection of the cervix as a
primary means of cervical cancer screening. Cent Afr J Med 1999;45(2) 30-3.
INFORMED CONSENT
I Dr.SNEHIL SINHA PG, Department of Obstetrics and Gynaecology,
conducting a research work for Award of MS Degree in Obstetrics and Gynaecology.
The Topic for the Study : A Study on comparing the efficacy of visual inspection of
cervix with acetic acid(VIA) and lugol’s iodine(VILI) with PAP smear cytology in
screening for cancer cervix in asymptomatic women.
This is a prospective study on aymptomatic women who are sexually active who
come to gynaecology out patient department and those admitted to gynaecology ward.It
will be carried out in KVG Medical College, Sullia.
Objectives :
1) To compare the efficacy of visual inspection of cervix with acetic acid (VIA) and
lugol’s iodine(VILI) with Pap smear cytology in screening for cancer cervix in
asymptomatic women.
2) Early detection of pre cancerous conditions and treating them before they progress
to invasive cancer.
I hereby state that the study procedures in details were explained and all questions
where fully and clearly answered to the participant / his/her relative.
Investigators Signature: :
Date :
Place:
Contact Address:
Dr. Snehil Sinha.
Post Graduate
Department of Obstetrics and Gynaecology
KVG Medical College, Sullia
Phone No.: 9880364674
I
have been told in a language that I understand
(
) about the study. I have been told that this is for a research procedure, that my
participation is voluntary and I/he/she reserve the full right to withdraw from the study at
my own initiative at any time, without having to give any reason and that right to
participate or withdraw from the study at any stage will not prejudice my/his/her, rights
and welfare. Confidentiality will be maintained and only be shared for academic purposes.
I hereby give consent to participate in the above study. I am also aware that I can
withdraw this consent at any later date if I wish to. This consent form being signed
voluntarily indicating my agreement to participate in the study until I decide otherwise. I
understood that I will receive a signed and dated copy if this form.
I have signed this consent form before my participation in this study.
Signature of the research subject :
Date :
Place:
Signature of the witness
Date :
Place:
PROFORMA
NAME
AGE
OP/IP NO
OCCUPATION
SOCIOECONOMIC STATUS
ADDRESS
AGE AT MENARCHE
AGE AT MARRIAGE
MENSTURAL HISTORY
OBSTETRIC HISTORY
H/O SEXUALLY TRANSMITTED DISEASE
PAST H/O HT/DM/ASTHMA/EPILEPSY/ TB
PAST H/O SURGERY
GENERAL EXAMINATION
HEIGHT
WEIGHT
BUILD / NOURISHMENT
ANEMIA
JAUNDICE
THYROID
BREAST
VITALS SIGNS
PULSE RATE
BP
RESPIRATORY RATE
TEMP
SYSTEMIC EXAMINATION:
CARDIOVASCULAR SYSTEM
RESPIRATORY STYSTEM
ABDOMINAL EXAMINATION
SPECULUM EXAMINATION
VISUAL INSPECTION WITH ACETIC ACID
VISUAL INSPECTION WITH LUGOL’S IODINE
Pap SMEAR CYTOLOGY
BIOPSY
REPORT
FOLLOW UP ACTION
MASTER CHART
s.no
name
i.p/o.p
age
s/e
status
Age at
menarche
Age at
marriage
parity
VIA
VILI
cytology
Biopsy
9
SIGNATURE OF THE CANDIDATE.
10
REMARKS OF THE GUIDE.
11
NAME AND DESIGNATION OF
Dr.RAMADEVI K,DGO,MS
11.1 Guide:
ASSOCIATE PROFESSOR
DEPARTMENT OF OBSTETRICS
AND GYNAECOLOGY
K.V.G MEDICAL COLLEGE
SULLIA.
11.2 Signature:
11.3 Head of the department:
Dr.VASUMATHY, MD
PROFESSOR AND HOD
DEPARTMENT OF OBSTETRICS
AND GYNAECOLOGY
K.V.G MEDICAL COLLEGE
SULLIA.
11.4 Signature:
PRINCIPAL
K.V.G MEDICAL COLLEGE AND HOSPITAL,SULLIA
ETHICAL COMMITTEE CLEARANCE
“COMPARING THE EFFICACY OF VISUAL INSPECTION OF CERVIX WITH
ACETIC ACID AND LUGOL’S IODINE WITH PAP SMEAR CYTOLOGY IN
SCREENING FOR CANCER CERVIX IN ASYMPTOMATIC WOMEN
1.TITLE OF DISSERTATION
2.NAME OF THE CANDIDATE
Dr. SNEHIL SINHA
3. NAME OF THE GUIDE
4.
APPROVED
APPROVED
/
Dr. RAMADEVI K,MS,DGO
NOT
Sri KRISHNAMURTHY ,Chairperson
Dr. SUBBANNAYYA KOTI GADDE, Secretary.
Dr. S. GOPAL RAO , Member
Dr. C. S. MOHANRAJ , Member
Dr. H. R. SHIVAKUMAR , Basic scientist
LAW EXPERT : Sri KRISHNAMURTHY , Advocate
PRINCIPAL
K.V.G. Medical College and Hospital , Sullia.