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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.