thesis dissertation protocol for the ethics

typanoplasty

1. SUBMISSION OF DISSERTATION PROTOCOL FOR THE APPROVAL OF INSTITUTIONAL ETHICS COMMITTEE ANDHRA MEDICAL COLLEGE

2. This presentation on “ CORRELATION OF SITE AND SIZE OF PERFORATION OF TYMPANIC MEMBRANE IN SAFE CHRONIC SUPPURATIVE OTITIS MEDIA WITH PURE TONE AUDIOMETRY ” by Dr. Abhilasha Jaiswal has been reviewed. Signature of guide

3. DISSERTATION PROTOCOL SUBMISSION SESSION 2022-2025 GUIDE : Name of the Guide : Dr.G.HARI KRISHNA M.S ENT Designation : Head of Department of ENT Name of department : E.N.T Name of institution : Government E.N.T Hospital, Andhra Medical College INVESTIGATOR: NAME : Dr. ABHILASHA JAISWAL DESIGNATION : POST GRADUATE DEPARTMENT : E.N.T TELEPHONE NUMBER : 8871873641 REGISTRATION NUMBER : MP-30000 Title of dissertation “ CORRELATION OF SITE AND SIZE OF PERFORATION OF TYMPANIC MEMBRANE IN SAFE CHRONIC SUPPURATIVE OTITIS MEDIA WITH PURE TONE AUDIOMETRY ”

4. DISSERTATION SYNOPSIS SUBMISSION FORM NAME OF THE CANDIDATE : ABHILASHA JAISWAL SESSION : 2022-25 DATE OF JOINING : 05 NOV 2022 HOSPITAL/INSTITUTE : Government E.N.T Hospital, Andhra Medical College, Vishakapatnam .

5. INTRODUCTION Chronic otitis media (COM) is the chronic inflammation of the middle ear cleft including mucosa, tympanic membrane and ossicles. It can be subdivided into non-suppurative and suppurative. Chronic non-suppurative is better known as otitis media with effusion. Chronic suppurative otitis media subclassification into non-cholesteatoma and cholesteatoma. The term safe (central perforation) associated with or without persistent ear discharge or intermittent ear discharge. The term unsafe [marginal perforation] associated with squamous epithelium ingrowth i.e. cholesteatoma. Non-cholesteatoma ears (with the presence of either a perforation or a retraction pocket) or cholesteatoma cases with ingrowth of keratin-producing epithelium whether this is via an attic perforation or in a pars tensa perforation or retraction. Various studies show prevalence of chronic otitis media in India to range from 2 to 15 %. In a study by Bluestone (2), India was considered to have a low prevalence area of 2% while a study from Haryana by Verma (3) reported it as high as 15.3%.

6. Tympanic membrane is divided into 2 parts : Pars tensa lower 2/3 rd and upper 1/3 rd Pars flaccida . All the 3 layers are present in pars tensa but fibrous layer is absent in pars flaccida . Tympanic membrane can be divided into 4 quadrants by 2 imaginary lines, 1 st horizontal line from the umbo. 2 nd vertical line from the handle of malleus. Size of the perforation is in relation to the quadrant. Small perforation is when only 1 quadrant is involved. Medium perforation when 2 quadrants are involved. Large perforation when 3 quadrants are involved. Subtotal/large when only thin rim of annulus is there. Marginal perforation when there is erosion of fibrous annulus or perforation of pars flaccida . The principal symptom of inactive CSOM is hearing loss. Depending upon the size and site of the perforation, the associated conductive hearing loss can vary between a minimal loss and 60dB.Perforation of the tympanic membrane exposing round window and oval window simultaneously, leads to more hearing loss because of loss of phase difference Pure tone audiometry is a subjective test, to measure the degree of hearing loss, the type of the hearing loss and the frequencies affected.

7. AIMS AND OBJECTIVES Using the oto -endoscope and correlating the association between size and site of tympanic membrane perforation with pure tone audiometry in safe chronic suppurative otitis media patients.

8. MATERIALS AND METHODS STUDY DESIGN:Hospital based prospective study. DURATION OF THE STUDY :June 2023 to December 2024(18 months)   SAMPLE SIZE : 50   SOURCE OF THE DATA : Study will be conducted in the Department of ENT, Government ENT Hospital, Andhra medical college, Visakhapatnam  

9. INCLUSION CRITERIA 1. AGE:18-50 YEARS 2. SEX: Both sex selected 3 . Patients with history of recurrent otorrhea within 5 years of the time of data collection.

10. EXCLUSION CRITERIA 1 Patients in whom hearing loss can be attributed to reasons other than chronic otitis media. Example: following traumatic perforation, history of long term intake of systemic ototoxic drugs, previous ear surgery, meningitis, enteric fever, head injury, diabetes mellitus, familial hearing loss, labyrinthitis, labyrinthine fistula are to be excluded from the study. Patients below the age of 18 years have been excluded due to difficulty in obtaining an accurate audiological profile and those above the age of 50 years are not selected so as to exclude the possible effects of aging process. 4.Patients who refused to give consent

11. ETHICAL CONSIDERATIONS The study will be conducted after obtaining clearance and approval from Institutional ethics committee, AMC, Visakhapatnam. Written informed consent will be obtained from those agreeing to participate in the study. Demographic data including age, sex,occupation,socioeconomic status, marital status and residence will be taken. Confidentiality of the subject will be maintained.

12. METHODOLOGY Patients ( Male and female in the age group of 18 to 50 years) who attended ENT out Patient Department with history of recurrent otorrhea were selected for this study. A thorough evaluation of 50 patients will be done by taking detailed history regarding the hard of hearing, ear discharge, otalgia, tinnitus, vertigo and associated symptoms followed by general physical & systemic examination and examination of ear, nose & throat.

13. STATISTICAL METHODS Data entry will be done in microsoft excel spread sheet The qualitative data will be expressed as numbers and percentages , and quantitative data as means and standard deviation . Chi square test will be applied for test association. Further, relevant statistical tests will be applied whenever necessary.

14. CASE SHEET PROFORMA NAME   SEX   OCCUPATION   AGE   ADDRESS   IP/OP NO.   INFORMANT     COMPLAINTS & DURATION H/O PRESENTING ILLNESS     CLINICAL EXAMINATION RIGHT LEFT 1. HISTORY OF EAR DISCHARGE 2. HISTORY OF HARD OF HEARING   3. HISTORY OF EAR PAIN   4. HISTORY OF TINNITUS 5. HISTORY OF VERTIGO   6. HISTORY OF NOISE EXPOSURE 7. HISTORY OF OTOTOXIC DRUG INTAKE 8. HISTORY OF FEBRILE ILLNESS   9. ANY OTHER COMPLAINTS

15. PAST HISTORY H/O SIMILAR COMPLAINTS IN THE PAST – MEDICAL OR SURGICAL MANAGEMENT IF ANY-  H/O SURGERY TO EAR / NEUROSURGICAL PROCEDURE- H/O HYPERTENSION, DIABETES, EPILEPSY, ASTHMA, TUBERCULOSIS- H/O CHRONIC MEDICATION USAGE- PERSONAL HISTORY: DIET – ANY FOOD ALLERGY   SLEEP AND APETITE   BOWEL AND BLADDER HABITS   HABITUATED TO SMOKING, CONSUMPTION OF ALCOHOL   MENSTRUAL HISTORY IN CASE OF FEMALES  

16. FAMILY HISTORY: GENERAL EXAMINATION: HEIGHT WEIGHT BMI CONSCIOUSNESS AND COHERENCE ORIENTATION TO TIME AND PLACE BUILT AND NOURISHMENT PALLOR / CYANOSIS / ICTERUS / CLUBBING / PEDAL EDEMA / GENERALISED LYMPHADENOPATHY VITAL DATA BP - / MM HG, SUPINE, RIGHT UPPER LIMB PR - BEATS/MIN, REGULAR, NORMAL RHYTHM AND VOLUME RR - /MIN FEBRILE / AFEBRILE SYSTEMIC EXAMINATION : CVS – RESPIRATORY – CNS- GIT-

17. ENT EXAMINATION EAR: RIGHT LEF T PREAURICULAR AREA- PINNA- POSTAURICULAR AREA- EXTERNAL AUDITORY CANAL - TYMPANIC MEMBRANE- TRAGAL TENDERNESS- MASTOID TENDERNESS- RINNES- WEBERS TEST- NOSE: THROAT:-

18. PROVISIONAL DIAGNOSIS:-   MANAGEMENT:-   INVESTIGATIONS: 1. HEMATOLOGICAL 2. URINE 3. SURGICAL PROFILE – VIRAL SCREENING, BLOOD GROUPING AND TYPING 4. RADIOLOGICAL- X RAY MASTOID 5. PRE-OPERATIVE OTOENDOSCOPY 6. PRE- OPERATIVE PTA

19. INFORMED CONSENT FORM ………………………. was explained about the study being undertaken by Dr. ABHILASHA JAISWAL, under the guidance of Dr.G.HARI KRISHNA, M.S (ENT), HEAD OF DEPARTMENT, Dept. of ENT, Andhra Medical College, Visakhapatnam. I have fully understood the details of the study and the procedures that I am subjected to. I have been given a chance to clear any of the doubts that aroused and that the confidentiality of subject will be maintained and the complications will be taken care of by the investigator with the help of KGH specialists that occur during the period of study. I was given the opportunity, whether or not to participate in the study. I was also told that I can withdraw from the study anytime according to my will. I hereby express my willingness to participate in the study without any coercion or whatsoever by signing this consent form. Signature of the Patient Date Signature of the Guardian Date Signature of Postgraduate Date

20. PATIENT INFORMANT SHEET I, DR. ABHILASHA JAISWAL doing a study titled CORRELATION OF SITE AND SIZE OF PERFORATION OF TYMPANIC MEMBRANE IN SAFE CHRONIC SUPPURATIVE OTITIS MEDIA WITH PURE TONE AUDIOMETRY” under the guidance of Dr.G.HARI KRISHNA M.S(ENT),Professor, Andhra Medical College. Before participating in this study you should know the following details. 1. A Consent form will be given to you in which you have to sign after reading it thoroughly. 2. We have to know your personal details, past medical and surgical history for information purpose. 3. A thorough general physical examination, systemic examination & Ear, Nose & Throat will be done as a part of the study. 4. We will collect your recent investigations which ever necessary for this study. 5 .You are not being forced to participate in this study. It’s up to you whether to participate or not. Thank you for your valuable time. Signature of Postgraduate Signature of Participant Date

21. సమ్మతి పత్రం నా, ____________ , ఆంధ్ర మెడికల్ కాలేజీ, విశాఖపట్నంలో సర్కారీ E.N.T. ఆసుపత్రిలో డాక్టర్ అభిలాషా జైస్వాల్ ఆధ్వర్యంలో చేస్తున్నాను. ప్రస్తుతం నా యొక్క ఒక అధ్యయనంలో పాల్గొని ఉన్నాను. ఈ అధ్యయనం లో నాకు అన్ని వివరాలు మరియు నా పై చేయబడే పరీక్షలు Dr. G. హరి కృష్ణ M.S. ద్వారా చెప్పబడ్డాయి. అధ్యయనం యొక్క వివరాలు మరియు నా పై జరుపు పరిక్షలు గురించి నేను పూర్తిగా అర్థం చేసుకున్నాను. నాకు వచ్చిన సందెహాలలో ఏ ఒక్క దానినైనా నివృత్తి చేసే అవకాశం నాకు దక్కింది. నా వ్యక్తిగత వివరాలు గోప్యంగా ఉంచబడ్డాయి. అధ్యయన కాలం లో చోటు చేసుకునే సంక్లిష్టతలు కేజీహెచ్ నిపుణుల సాయంతో పరిశోధకుడు చికిత్స చేస్తారు. అధ్యయనంలో పాల్గొనాలా వద్దా అనే నిర్ణయం తీసుకోవడానికి నాకు అవకాశం ఇవ్వబడింది.నా సంకల్పానికి అనుగుణంగా ఎపుడైనా అధ్యయనం నుంచి ఉపసంహరించుకోవచ్చని కూడా నాకు చేప్పబడింది.ఈ సమ్మతి పత్రం పై సంతకం చేయడం ద్వారా ఎలాంటి నిర్భందనలు మరియు ఒత్తిడి లేకుండా ఈ అధ్యయనం లో పాల్గొనాలనే నా సుముఖతను నేను ఇందుమూలంగా తెలియజేస్తున్నాను. రోగి సంతకం___________ సాక్షి సంతకం___________ వైద్యుడి సంతకం__________

22. REFERENCES 1] Ibekwe TS, Nwaorgu OG, Ijaduola TG. Correlating the site of tympanic membrane perforation with hearing loss. BMC Ear Nose Throat Disord 2009 2]Chole R, Sudhoff HH. Chronic otitis media. In: Cummings Oto - laryngology—Head and Neck Surgery. 5th ed. hiladelphia , PA: Mosby;2005:4985-4986 3] Maharjan M, Kaf le P, Bista M, Shrestha S, Toran KC. Observation of hearing loss in patients with chronic suppurative otitis media tubotympanic type. Kathmandu Univ Med J KUMJ) 2009;7(28):397–401 4]Bluestone CD. Epidemiology and pathogenesis of chronic suppurative otitis media: implications for prevention and treatment. Int J Pediatr Otorhinolaryngol 2018;42(3):207-223 5] American Academy of Otolaryngology Head and Neck. Perforated Ear Drum. [Internet]2005[cited March 2010]. Available athttp://www.entnet.org/HealthInformation/ perforatedEardrum.cfm 6] Ahmad SW, Ramani GV. Hearing loss in perforations of the tympanic membrane. J Laryngol Otol 1979;93(11):1091–1098 7] Ronald NJ, McRac RD, McCombe AW, Chronic suppurative otitis media. In: Key Topics in Otolaryngology and Head and Neck Surgery. 2nd ed. Wales: Bios Scientific Publishers 2001;38–41  8] Voss SE, Rosowski JJ, Merchant SN, Peake WT. How do tym - panic-membrane perforations affect human middle-ear sound transmission? Acta Otolaryngol 2001 9]Oluwole M, Mills RP. Tympanic membrane perforations in children. Int J Pediatr Otorhinolaryngol 1996;36(2):117–123

23. పేషెంట్ ఇన్ఫా ర్మ ెంట్ షీట్ నేను , DR. అభిలాషా జైస్వాల్ “ ప్యూర్ టోన్ ఆడియోమెట్రీతో సురక్షితమైన క్రానిక్ సప్పూరేటివ్ ఓటిటిస్ మీడియాలో సైట్ యొక్క సహసంబంధం మరియు టిమ్పానిక్ పొర యొక్క పెర్ఫరేషన్ పరిమాణం ” అనే శీర్షికతో అధ్యయనం చేస్తున్నారు . G. హరికృష్ణ , MS ENT, ప్రొఫెసర్ మరియు HOD, ENT విభాగం , ప్రభుత్వ ENT ఆసుపత్రి , ఆంధ్రా వైద్య కళాశాల1.మీకు సమ్పచార్ సమమ ి పప్రత్ెం ఇవవ బడుతుెంది , దానిని పూరిగా చదివిన త్రావి త్ మీరు సెంత్క్ెం చేయాలి . అధయ యనెంలో ప్లల్గొనడానికి మీ సమమ ి త్పా నిసరి . సమ్పచార్ ప్రపయోజనెం కోసెం వయసుు , లిెంగెం , వృి , ి నివాసెం , గత్ వైద్య మరియు శస్తసచికిత్ుి చరిప్రత్ వెంటి జన్ఫభా వివరాలు . అధయ యనెంలో భాగెంగా క్షుణ్ెంగా సాార్ణ్ శారీర్క్ పరీక్షణ , దైహిక్ పరీక్ష & చెవి , ముకుక & గెంతు పరీక్ష చేయబడుతుెంది . ఈ అధయ యన్ఫనికి అవసర్మైన మీ ఇటీవలి పరిశోధనలను మేము సేక్రిసాిము . మేము చేయబోయ్య న్ఫసల్ ఎెండోస్కక పీ విానెం మరియు CT పరాన్ఫసల్ సైనస్ల గురిెంచి మీకు వివరిెంచబడుతుెంది . మీరు ఈ అధయ యనెంలో ప్లల్గొనవలస్థెందిగా బలవెంత్ెం చేయబడటెం లేద్ద . ప్లల్గొ న్ఫలా వదాు అనేది మీ ఇష్ెంట . ఈ అధయ యనెంలో ప్లల్గొనడెం దావ రా , మీరు రోగులకు న్ఫణ్య మైన సెంర్క్షణ్ను అెందిెంచడెంలో వైద్దయ లకు సహాయెం చేసాి రు , ఇక్క డ అెందిెంచిన సమ్పచార్ెం శాస్తస్టయెంగా విిశ్లషెంచబడుతుెంది ా మరియు ప్రపసుిత్ చికిత్ు ప్రోటోక్టల్లను మెరుగుపర్చడెంలో మ్పకు సహాయపడుతుెంది . మీ విలువైన సమయానికి ధనయ వాదాలు . ోస్ ప్రగాడుయటయ్యట్ సెంత్క్ెం ప్లల్గొ నేవారి సెంత్క్ెం . తేదీ త్లిద్ెంప్రడులుా / సెంర్క్షకుల సెంత్క్ెం ( ప్లల్గొ నే వయ కి మైనర్ అయితేి రోగి సంతకం ___________ సాక్షి సంతకం ___________ వైద్యుడి సంతకం __________

24. PARTICIPANT INFORMATION SHEET I, Dr. Abhilasha jaiswal doing a study titled – “ CORRELATION OF SITE AND SIZE OF PERFORATION OF TYMPANIC MEMBRANE IN SAFE CHRONIC SUPPURATIVE OTITIS MEDIA WITH PURE TONE AUDIOMETRY ” PRINCIPAL INVESTIGATOR : Dr. Abhilasha Jaiswal PLACE OF STUDY : GOVERNMENT ENT HOSPITAL, ANDHRA MEDICAL COLLEGE, VISAKHAPATNAM. CONTACT NO : 8871873641 INTRODUCTION TO RESEARCH STUDY : You are being asked to take part in the study because you are a patient with symptoms of unilateral or bilateral ear discharge which are chronic in nature (more than 6 months) PURPOSE OF STUDY : Study regarding clinical course of patients with ear discharge and the possibility of deviated septum being reason for the ear pathology . ELIGIBILITY FOR PARTICIPATION (WHO CAN TAKE PART): Patients having symptoms ofunilateral or bilateral ear discharge which are chronic in nature (more than 6 months).

25. EVENTS DURING THE STUDY (WHAT WILL HAPPEN DURING THE STUDY ): Patients’ symptoms are noted with adequate history and clinical examination. ROLE/RESPONSIBILITY OF SUBJECT DURING THE STUDY : Provide accurate information whenever asked. Must inform the study doctor about any problems during the study. Follow the investigator’s instructions. If you want to discontinue from the study, inform the doctor .

26. WHAT ARE THE POTENTIAL BENEFITS OF PARTICIPATING IN THE STUDY : You may or may not benefit from the study. It is possible that you may get better, stay the same or worsen. If you take part in the study, you may help other patients by contributing to the knowledge on managing the disease process. COST OF PARTICIPATING IN THE STUDY : NIL COMPENSATION FOR INJURY : NIL CONFIDENTIALITY OF INFORMATION : Information from the study, including your name, address, medical records, results of tests and study results will be reviewed only by authorized personnel from the ethics committee or regulatory body. Information and results from this study may be presented at meetings or published in journals without including your name or identification.

27. NEW INFORMATION ABOUT THE STUDY : Any new information obtained during the course of the treatment will be informed to you if it has relevance to your decision regarding continuing in the study. VOLUNTARY PARTICIPATION : Entering a research study is voluntary. If you volunteer for a research study , you have the right to stop at any time and you need not give any reason for the same. Your decision not to participate in the study will not affect your future treatment. The investigator may stop the research or your participation in it at any time.

28. THANK YOU