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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA. ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1. NAME OF THE CANDIDATE AND ADDRESS DR. VIDYA JANAKI. R. PG IN ENT, KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI – 580 022. 2. NAME OF THE INSTITUTION KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI-22. 3. COURSE OF THE STUDY AND SUBJECT M.S. IN ENT. 4. DATE OF ADMISSION TO THE COURSE 10-06-2008. 5. TITLE OF THE TOPIC CORRELATION OF SITE AND SIZE OF TYMPANIC MEMBRANE PERFORATION WITH PURE TONE AUDIOGRAM. 6. BRIEF RESUME OF INTENDED WORK: 6.1 NEED FOR THE STUDY: Chronic suppurative otitis media(CSOM) is a wide spread disease of the developing countries like India especially in the rural areas. It is one of the commonest causes of hearing loss that mainly results due to a tympanic membrane perforation. The large effective surface area of an intact and normally vibrating tympanic membrane plays a major role in the middle ear transformer mechanism. Perforation of the tympanic membrane is a common cause for hearing loss due to loss of effective area of vibration. Perforations can result from various reasons including middle ear disease, trauma. It has been generally believed that the degree of hearing loss increases with the size of the perforation. Many prior clinical studies have shown that hearing loss associated with perforation was more at low frequencies than at high frequencies and it increases with the size of perforation. Correlation of the site of perforation to hearing loss is not very clearly established though a few studies have shown no significance of site of perforation. Another showed postero inferior perforation caused more hearing loss than others. Accurate assessment of the TM Perforation and its relationship with hearing loss is important as it enables the clinician to optimally assess the condition and offer an appropriate solution. Hence the need for the study. 6.2 REVIEW OF LITERATURE: 1. In 1979, Ahmad.S.W and Ramani G. V studied 70 patients with dry central perforations to assess the hearing loss and concluded that hearing loss was greater at the lower frequencies and increases with the size of the perforation. They also found that posteroinferior quadrant perforations caused more hearing loss than antero inferior ones, the difference being greater at lower than at higher frequencies.1 2. In 2006, Ritvik P Mehta, Rosowski J John et al conducted a study on 56 patients with isolated TM Perforations and showed that hearing loss is frequency dependant and the greatest loss occurred at the lowest frequencies, hearing loss increased with increase in size of perforation, varied inversely with middle ear volume and does not vary substantially with location of the perforation.2 3. In 2003, Bhusal C L et al studied fifty patients with CSOM –Tubo tympanic type undergoing myringoplasty and showed that hearing loss was more at lower frequencies and less as frequencies increase and hearing loss increased with the size of perforation.3 4. In 2001 ,Voss S E, Rosowski JJ et al measured acoustic transmission before and after making controlled perforations in cadaver ears and showed that perforations caused frequency dependent loss that was largest at low frequencies ,increased as the size of perforation increased and did not depend on perforation location.4 5. In 1972, Walter P et al studied the effects of both size and location of tympanic membrane perforations on hearing loss in 103 patients who had undergone myringoplasty and concluded that effectiveness of the TM decreased with loss of total area.5 6.3 AIMS OF THE STUDY: 1. To record the site and size of tympanic membrane perforations. 2. To correlate the site and size of the perforation with pure tone audiogram in such patients who fulfilled the study criteria.. 7. MATERIALS AND METHODS: 7.1 SOURCE OF DATA: Patients attending ENT OPD in KIMS, Hubli in the study period from January 2009 to December 2009 who have a tympanic membrane perforation. 7.2 METHODS OF COLLECTION OF DATA: A cross sectional, correlative study is planned. Every consecutive eligible patient will be recruited into the study and divided into two to three groups depending on the size of the perforation. The site of perforation will also be recorded and a pure tone audiogram will be performed on the patient. The data obtained will be analyzed using an appropriate statistical test. INCLUSION CRITERIA: 1. Subject should have central TM perforation due to trauma or CSOM. 2. All subjects should have dry ears ( duration 3 months ) 3. Patients with intact ossicular chain- confirmed by patch test. 4. Age between 10 to 60 years. EXCLUSION CRITERIA: 1. Patients with Attico- antral disease- presence of cholesteatoma or granulation tissue. 2. Active CSOM. 3. Patients with ossicular chain pathology. 4. Patients who cannot give a valid and consistent PTA response. 5. Patients with sensorineural hearing loss. 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” Pure tone audiometry and patch test. 7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3? Yes, Ethical clearance has been obtained from ethical committee of KIMS, Hubli. 8. LIST OF REFERENCES: 1. Ahmad S W and Ramani G V “Hearing loss in perforations of the tympanic membrane.” The Journal of Laryngology and Otology 1979;93;1091-1098. 2. Ritvik P Mehta et al “Determinants of hearing loss in perforations of the tympanic membrane.” Otology and Neurology 2006;27;136-143. 3. Bhusal et al “Size of tympanic membrane perforation and hearing loss.” JNMA J Nepal Med Assoc. 2006;45(161);167-172. 4. Voss S E et al “How do tympanic membrane perforations affect human middle ear sound transmission?”Acta otolaryngol. 2001 jan;121(2):169-73. 5. Walter P Anthony et al “Tympanic membrane perforation” Archives of otolaryngology 1972;vol 95 :504-510. 6. Ajith kumar U and Vikram Bhat K. “Do the site and size of tympanic membrane perforation correlate with audiogram?”Asian journal of Ear,Nose and Throat 2000;4;25-30. 7. Vikram J Jaisinghani et al “quantitative analysis of tympanic membrane disease using video –otoscopy” The Laryngoscope 2000 oct:110:1726-1730. 8. Ibeweke TS et al “quantitative analysis of tympanic membrane perforation:a simple and reliable method. The journal of laryngology and otology 2008 oct 22:14. 9. Ibeweke TS et al “assessments of the size of tympanic membrane perforations:a comparison of clinical estimations with video otoscopic calculations. Ear Nose and Throat Journal. 2008 oct:87(10):567-569. 10. Payne M C and Glither F J 1951 archives of otolaryngology, 54 666-674. 9. SIGNATURE OF THE CANDIDATE 10. REMARKS OF THE GUIDE 11. 11.1 11.2 12 NAME AND DESIGNATION OF DR. VIKRAM K BHAT MS, DNB, Phd. THE GUIDE ASSOCIATE PROFESSOR OF ENT DEPARTMENT OF ENT, KIMS, HUBLI. SIGNATURE 11.5 HEAD OF THE DEPARTMENT 11.6 SIGNATURE 12.1 REMARKS OF THE CHAIRMAN AND THE PRINCIPAL 12.2 SIGNATURE DR. UMESH S NAGALOTIMATHMS,DNB PROFESSOR & HEAD, DEPARTMENT OF ENT, KIMS, HUBLI.