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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE ANNEXURE – II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION : 1. NAME OF THE CANDIDATE Dr.SHILPA TUBAJIRAO HOTKAR AND ADDRESS PG IN E.N.T DEPARTMENT OF E.N.T MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE – 570 001. 2. NAME OF THE INSTITUTION 3. COURSE OF STUDY AND SUBJECT 4. DATE OF ADMISSION TO THE COURSE : MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE : MS ENT : 16th JUNE 2012 : 5. TITLE OF THE TOPIC “CORRELATION BETWEEN CHRONIC SUPPURATIVE OTITIS MEDIA AND SINONASAL PATHOLOGY ’’ 1 6. BRIEF RESUME OF THE INTENDED STUDY 6.1 Need for the study Chronic suppurative Otitis media (CSOM) is the chronic inflammation of the middle ear (ME) cleft with history of ear discharge for more than 3 months & permanent tympanic membrane defect. .Middle ear cleft constitutes Eustachian tube, tympanic cavity, attic, aditus, antrum and mastoid air cells lined by epithelium and in continuity with the atmosphere of nose and nasopharynx. The pathogenesis of CSOM has been related to the presence of prior or concurrent nasal disease. Infection of the nose and paranasal sinuses (PNS) can involve the Eustachian tube (ET) leading to its obstruction. Chronic Obstruction of ET in turn leads to CSOM. Diseases of the nose and PNS can thus influence the ME condition. Although most of the literature refers to sinusitis and upper respiratory tract as causative factor of CSOM ,only few articles refer to actual nasal pathologies that can lead to it. Those patients who have CSOM secondary to nasal and/or PNS pathology need to have both problems addressed. Those who need surgery on the ear should have nasal and/or PNS problems attended to first, if an ear operation is to be successful. The present study was undertaken to evaluate the correlation between nose and PNS pathology and CSOM. 6.2 Review of literature The upper respiratory tract including nose, Eustachian tube, paranasal sinuses are lined by pseudostratified ciliated columnar epithelium. They also contain non ciliated columnar epithelium, basal cells and goblet cells. In cases of chronic inflammation, there is an increase in size and number of goblet cells. The mucus secreted by the paranasal sinuses are cleared by motility of the cilia, which are 50 to 200 per cell and they beat at the rate of 700 to 800 beats per minute moving at the rate of 1cm per minute.In patients with sinusitis, the etiology being the anatomical variants leading to stasis of secretions, allergy, viral, bacterial, fungal infections; there is alterations in the quality and quantity of the secretions. In some patients,the cause for sinusitis being 2 genetic and congenital defect in mucociliary clearance like Kartageners syndrome,cystic fibrosis, primary ciliary dyskinesia, young’s syndrome and also acquired mucociliary dysfunction due to smoking, pollution, medication and surgery. The normal mucociliary clearance in which the anterior group of sinuses like frontal, maxillary and anterior ethmoidal sinuses drain along the anterior and inferior part of pharyngeal end of Eustachian tube. The posterior group of sinuses including the posterior ethmoid and sphenoid sinuses drain posterior and superior to Eustachian tube. In sinusitis, the quality and quantity of mucous is altered to either purulent or mucopurulent . This leads to alteration in the mucosa lining the pharyngeal end of Eustachian tube with edema, inflammation of subepithelial lymphoreticular network leading to block and obstruction of Eustachian tube and this leads to reduced ventilation and changes in mucosal lining of middle ear cleft. This leads to hypertrophy and increase in number of goblet cells in middle ear cleft. Hence, sinusitis causes inflammation of the middle ear mucosa with increased and persistent mucoid / mucopurulent discharge and remains as a active mucosal disease. 1. A study by sankaranarayan Gopalakrishnan, satheesh kumar1in 2012 at Kilpaulk medical College, Royepettah Hospital :Evaluation revealed that sinusitis in chronic otitis media patients was the cause for persistent discharge. All patients had one or more evidence of sinusitis like pus in middle meatus , deviated nasal septum and turbinoseptal deformities ,prominent enlarged bullae , enlarged middle turbinate on DNE and CT. The otoendoscopy showed inflamed and boggy middle ear mucosal status. All patients underwent septoplasty /FESS depending on findings .Out of 60 patients 52 patient had improvement in middle ear mucosal status with surgery. 2. A prospective study by Aditya M Yeolekar And K S Sengupta8 at Department of ENT, Indira Gandhi Medical college, Nagpur, India,was conducted wherein distribution of sinonasal disease was studied in all 200 patients and concluded that sinonasal disease is the most common cause for the persistence of ear symptoms in chronic otits media and supported by their improvement after treating the sinonasal pathology. They have 3 emphasized that evaluation and management of sinuses is a must in all cases of chronic otitis media. 3.A Fujita, I Honjo, K.Kuzata2 has studied cases of refractory otitis media in 83 adolesents with 103 controls and they had concluded after evaluating the various parameters including the Eustachian tube function and found that 48% of the cases had refractive ear disease due to sinusitis and 78% had abnormal sinuses and concluded that in cases of chronic otitis media refractory to treatment the main focus of pathology/infection is in sinuses. 4.In 1989 Bluestone and his collegues7 studied about 40 patients of chronic otitis media active mucosal type and found Eustachian tube dysfunction to be reason for the persistence of the disease. He concluded that diseases of the sinuses as the main cause rather than adenoid in adolescents and adults for Eustachian tube block. 5.M Miura and H Takashi5 in 1995 studied on the influence of upper respiratory infection including sinusitis on tubal compliance in children and adolescents with otitis media. They concluded that72% of patient with refractory tubal compliance due to chronicity of upper respiratory infection including sinusitis leading to persistence of otitis media. 6.In an observation made by M.J. Lorenson in 2002, when persistent ear discharge is found, it is extremely important to rule out history of upper respiratory infection, colds and sinusitis.5 6.3 Aims and Objectives of the study 1.To study the correlation between chronic suppurative otitis media (CSOM) and sinonasal pathology. 2.To study whether the sinonasal pathology is a focus of infection for CSOM. 4 7. MATERIALS AND METHODS 7.1 Source of data: “Observation method of primary source of information” technique will be used on registered CSOM patients, registered in ENT department of Mysore Medical College and Research Institute, Mysore for collecting relevant information after using “Informed Written Consent ’’ method as to get patient’s consent. 7.2 Sample size and sampling methodology: Prevalence of CSOM according to WHO in India is 7.8%. Using “ Estimation method “ with allowable error and level of significance of 5%,the inflated sample size will be 115 and these sampling elements will be selected on convenience basis. 7.3 Duration of study: The dated duration of the study is eighteen months from December 2012 to May 2014. 7.4 Study Design: Cross sectional study 7.5 Statistical techniques: Proportion, Chi square test or Z test for proportion, Bar chart, Pie chart, Multiple bar chart, and related statistical techniques will be used using statistical softwares. Inclusion criteria: Patients of both sexes and more than 10 years of age presenting with 1. Chronic Suppurative otitis media- Atticoantral type 2. Chronic Suppurative otitis media- Tubotympanic type Exclusion criteria: 1. Traumatic perforation 2. Traumatic dislocation of ossicles 3. Acute infection of nose and PNS 4. Age < 10 years 5. Acute suppurative otitis media 6. Otitis media with effusion 7. Carcinoma of middle ear 5 8. Cases associated with medical comorbidities like diabetes mellitus, immunocompromised status. 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION / INTERVENTION TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? -YES All patients entering the present study will undergo following investigations: Investigations : 1. Hemogram 2. X-ray and CT scan both mastoids 3. X-ray and CT Scan PNS 4. Otomicroscopy and Otoendoscopy 5. Diagnostic Nasal endoscopy 6. Bacteriological study of ear discharge 7. Bacteriological study of nasopharyngeal swab 8. Pure tone audiometry 7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3? YES (copy enclosed) 7.5 DURATION OF STUDY 18 months ( 1st December 2012 - 30th May 2014) 8. LIST OF REFERENCES: 1. Sankaranaryanan Gopalakrishnan, Satheesh kumar Kilpaulk Medical College, Royepettah Hospital: A study on chronic otitis media active mucosal type with sinusitis 6 as focal sepsis ,Otolaryngology online journal ,Vol 2 ,No. 4(2012),Issue 4 2012 URL: jorl.net 2. A Fujita, I.Honjo, K.Kuzeta, Refractory Otitis Media, Organic Abnormalities of Euastachain tube dysfunction. American Journal of Oto Laryngology Volume 14, Issue 3, May – June 1993, Page 187 to 190. 3. Stammberger, Functional endoscope sinus Surgery 1992.105 – 113. 4. Scott-Brown’s , Otorhinolyrngology, Head and Neck Surgery, 7th Edition, 2008, 1469-1478, 3395-3446,1315-1340. 5. M.Miura and Takashi influence of URTI on tubal complaints and Otitis Media, Acta – Oto- Laryngologica 1997, Volume 117, No. 4, Page 574 to 577. 6. Paparella M, Shumirick D, Gluekman J, Meyerofw: Otolaryngology, Volume 1(1991) physiology of middle ear and E.tube function in tympanoplasty. Acta otolaryngol (Stock) 1990. Supply 471: 9-12. 7. Blue Stone CD: Assessment of Eustachian tube function. In Jerger J (Ed): Handbook of clinical impedance Audiometry, New York, American Electormedics Corporation, 1975, pp. 127-148. 8. Yeolekar AM, Dasgupta KS, Otitis Media: Does the onus lie on sinonasal pathology? Indian J Otol 2011;16 9. Ballengerr’s Otorhinolaryngology, Head and Neck Surgery 17th Edition1-17, 201229, 567-577. 7 ETHICAL COMMITTEE CLEARANCE 1. Title of Dissertation : “ CORRELATION BETWEEN CHRONIC SUPPURATIVE OTITIS MEDIA AND SINONASAL PATHOLOGY ’’ 2. Name of the Candidate : Dr. SHILPA TUBAJIRAO HOTKAR 3. Subject : MS ENT 4. Name of the Guide : Dr. K. M. GOVINDE GOWDA, MS ENT Professor And Unit Chief Department Of ENT Mysore Medical College and Research Institute, Mysore 5. Name of the Co- Guide : Dr. P.S. MARADESHA, MS ENT Asst. Professor Department of ENT Mysore Medical College and Research Institute, Mysore 6. Approved / Not Approved : Approved (If not approved, suggestion) 8