RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA.

ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

NAME OF THE CANDIDATE AND ADDRESS (IN BLOCK LETTERS)

DR. SAURABH RAJ ROOM NO. 4, PG MENS HOSTEL, BMCRI, BANGALORE -2

NAME OF THE INSTITUTION

BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE, BANGALORE- 560002

COURSE OF STUDY AND SUBJECT

MS IN ENT

DATE OF ADMISSION TO THE COURSE

31-05-2011

TITLE OF THE TOPIC

A CLINICAL STUDY OF TRAUMATIC PERFORATION OF TYMPANIC MEMBRANE

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BRIEF RESUME OF INTENDED WORK: 6.1 Need for the study: Traumatic perforation of the tympanic membrane is a common injury that is under-reported, there is the need to educate on unskilled removal of foreign body, early identification, evaluation and referral of patients so as to reduce the morbidity1. Although traumatic TM perforations have good prognosis, it is necessary to induce patients with profuse explanations for possible complications to visit the out-patient clinic until the wound has healed completely2. 6.2 Review of Literature: A retrospective study of tympanic membrane perforation done by Chun SH et al at general hospital, Seoul, Korea from January,2002 to December,2007 on 152 cases showing perforation of Grade I was most common, with 86 cases (57%). Among them,with 54 cases (35.5%), antero-inferior perforation constituted about one third of all cases.The mean air-conduction difference was 14.7dB, and showed a tendency to increase as the size of perforation increased.Spontaneous healing rate was 76%, and the mean duration for complete healing was 22.1 days.There was also a tendency for the duration of healing to increase as the size of perforation increased. In the case of complication with otorrhea, there was a tendency for the duration of healing to be shorter4. A long-term follow-up study of traumatic tympanic membrane perforations was done by Kristensen et al on 37 patients which showed that early surgical intervention of a traumatic myringeal perforation is not indicated, as most of these perforations (an average of 88%) do heal spontaneously without complications,further stressing the importance of performing a meticulous auditory and vestibular examination with close follow-up and repeat audiograms in all patients with acute traumatic myringoruptures to provide enough information for diagnosis of a major perilymph leak that would warrant operation. Myringeal perforations or major conductive hearing losses persisting 3 months after injury warrant tympanotomy and appropriate reconstruction5. An observational study of the management of traumatic tympanic membrane perforations was by conducted by J. E. O. Amadasun at Westend Hospital and Diagnostic Centre, Warri, Nigeria which showed that the management of a fresh tympanic membrane perforation should be limited to cleaning the traumatized ear and preventing infection7. A retrospective study was carried out by Griffin WL Jr. on 227 traumatic tympanic membrane in a clinical practice of otolaryngology between January 2007 and July 2009. The following conclusions were supported by the data: 1.Larger perforations are less likely to heal spontaneously. 2. Lightning and molten metal injuries are less likely to heal spontaneously. 3. Final healing and hearing results are good regardless of the mode of therapy

employed. 4. Spontaneous healing gives better results than early surgical intervention. 5. Infection adversely affects healing in traumatic perforations10. 6.3 Aims and Objective of the study: 1)To evaluate the various aetiology of traumatic membrane perforations. 2)To evaluate the prognosis and outcome of traumatic tympanic membrane perforations by various means of management. 7 MATERIALS AND METHODS: 7.1 Source of data: Patients ( aged 12-50 years) of either sex, irrespective of socio economic status presenting with traumatic perforation of tympanic membrane at Sri Venkateshwara ENT Institute, Victoria Hospital and Bowring and Lady Curzon Hospital attached to Bangalore Medical College and Research Institute, Bangalore. 7.2 Methods of collection of data:
A. Study design: Prospective study B. Study period: November 2011- may 2013

C. Place of study: Sri Venkateshwara ENT Institute, Victoria Hospital and Bowring and Lady Curzon Hospital attached to BMCRI, Bangalore.
D. Sample size: 50 E. Inclusion Criteria:

1) Subjects 12-50 years of age and of both the sexes irrespective of socioeconomic status. 2) Able to comply with study procedures. 3) Informed written consent in English or Kannada. F. Exclusion Criteria: 1) Subjects less than 12 years and above 50 years. 2) Subjects underwent any form of ear surgery involving tympanic membrane in the past. 3) Subjects having middle ear infections.

4) Tympanic membrane perforations caused due blast injuries.

G. Methodology: After obtaining clearance and approval from the Institutional Ethics Committee, 50 patients fulfilling Inclusion/Exclusion who give Informed Consent (Annexure 1) will be included in the study. Data is collected from the patients presenting to the ENT department. Following data will be collected from case sheets of patients in a Study Proforma (Annexure 3). H. Statistical analysis:

Quantitative or qualitative results will be analyzed using Z-score or chi square test wherever applicable.
7.3 Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so, please describe briefly.

Yes. After informing the patients and obtaining prior written consent, the patient will be subjected to investigations, as indicated. No animal study is required.
7.4 Has the ethical clearance been obtained from your institution in case of 7.5? YES. The ethical clearance has been obtained from the ethics committee of Bangalore Medical College and Research Institute, Bangalore.

LIST OF REFERENCES: 1) Peter JK, Paul HK: Principle of trauma. In Byron J Bailey Head and Neck Surgery - Otolaryngology Volume 61. 3rd edition, Edited by: Byron J, Karen H, Gerald B, Harold C, Jonas T, Eugene M, Robert K, Anthony Pazos, Chri Gralapp, Lippincott Williams & Wilkins Publishers; 2001: 69 of 202. 2) Ologe FE: Traumatic perforation of tympanic membrane in Ilorin, Nigeria. Nig J Surg 2002, 8(1):9-12. 3) Da Lilly-Tariah OB, Somefun AO: Traumatic perforation of the tympanic membrane in University of Port Harcourt Teaching Hospital, Port Harcourt. Nigeria., Niger Postgrad Med J 2007.

4) Chun SH, Lee DW, Shin JK:A Clinical Study of Traumatic Perforation Of Tympanic Membrane,Department of Otolaryngology, Hanil General Hospital, Seoul, Korea. 5) Kristensen S et al: Traumatic tympanic membrane perforations:complications and management.Ear Nose Throat J.2009 Jul;68(7):503-16. 6) Schwaber Mitchell: Trauma to the Middle Ear,Inner Ear, and Temporal Bone.In Ballengers Otorhinolaryngology Head and Neck Surgery.Volume 14.Sixteen edition. Edited by James B Snow Jr,John Jacob Ballenger. DC Becker Inc; 2003:345-356. 7) Amadasun JE: An observational study of the management of traumatic Tympanic membrane perforations. J. Laryngol. Otol.2002; 116(3): 181-184. 8) Fernandez G, Sharma VM, Amedee RG. Traumatic perforation of the tympanic membrane. J La State Med Soc. 2001 Mar;153(3):116-8. 9) Kazuharu Yamazaki, Ken Ishijima, Hiaraoki Sato. A Clinical study of traumatic tympanic membrane perforation. 2010; 113(8):679- 686 10) Griffin WL Jr: A retrospective study of traumatic tympanic membrane perforations in a clinical practice.2009; Laryngoscope 89 (2 part 1) : 261-282.

SIGNATURE OF CANDIDATE

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REMARKS OF THE GUIDE

Traumatic perforation of tympanic membrane is commonly encountered in out patient department.It is one of the important causes of conductive hearing loss.Most of the times conservative means is effective,if failed surgical intervention is required.It is important medicolegally,hence the need for study. Dr. SAROJAMMA
MBBS, MS.

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NAME AND DESIGNATION 11.1 GUIDE

PROFESSOR, DEPARTMENT OF ENT, BMCRI, BANGALORE. 11.2 SIGNATURE

11.3 CO-GUIDE ( IF ANY)

NONE

11.4 SIGNATURE

11.5 HEAD OF THE DEPARTMENT

Dr. H.S. SATISH MBBS, DLO, MS. PROFESSOR & HEAD, DEPARTMENT OF ENT, BMCRI, BANGALORE.

11.6 SIGNATURE

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12.1 REMARKS OF CHAIRMAN AND PRINCIPAL

12.2 SIGNATURE