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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA. ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the Candidate and DR.BHAT SUPRIYA MOHAN Address (In Block Letters) PG IN ENT SRI VENKATESHWARA ENT INSTITUTE, VICTORIA HOSPITAL, BANGALORE: 560002. 2. Name of the institution BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE. 3. Course of study and Subject M.S. IN ENT 4. Date of admission to the course 02-05-2009 5 Title of the topic A CLINICAL STUDY AND MANAGEMENT OF CAVITY PROBLEMS ENCOUNTERED IN CANAL WALL DOWN MASTOIDECTOMY. 6. BRIEF SUMMARY OF THE INTENDED WORK 6.1 NEED FOR THE STUDY Chronic suppurative otitis media (CSOM) is a long standing infection of a part or whole of middle ear cleft characterized by intermittent or persistent, chronic purulent drainage through a perforated tympanic membrane. One of the surgical modalities of treatment for this is canal wall down mastoidectomy (CWDM) which broadly means a procedure requiring removal of the posterior wall of external auditory canal. It includes both radical and modified radical mastoidectomy. The advantages of this procedure include excellent intraoperative exposure of cholesteatoma facilitating eradication of disease and easy detection of recurrence postoperatively. It decreases the need for second stage operation and hence is costeffective. The above factors make it an optimum surgery especially in the Indian setting. The major drawback with this procedure is the cavity problems like discharging ear, granulations, wax and keratin accumulation, difficulty in prescribing hearing aids, dizziness and small meatus encountered postoperatively. Few studies have been carried out in this respect especially in the Indian scenario. If cavity problems and the means to prevent or alleviate them are identified, quality of life of patients can be improved. Hence the need for this clinical study. 6.2 REVIEW OF LITERATURE Chronic otitis media with cholesteatoma is a potentially dangerous disease because it can lead to life threatening intracranial complications. The objective of surgery for chronic otitis media with cholesteatoma and chronic otomastoiditis is to eradicate the disease and prevent recurrence. CWDM is the most widely used surgical method worldwide. It is supposed to be easier, of shorter duration, necessitates less surgical experience than the canal wall-up procedures, and has low recurrence and residual rate. The anatomic and functional outcome is satisfactory, and the rate of complications is acceptably low. A tympanoplasty can also be performed simultaneously.1, 2 In a retrospective review of 101 patients who underwent canal wall down procedure, the average visits per patient was 13.3 (median of 11 visits). The greatest number of visits occurred in the first 24 months after surgery with the commonest reasons being the removal of the clinical features of chronic cavity inflammation like wax, keratin accumulation, discharge, debris and granulation tissue. Residual or recurrent cholesteatoma, residual perforations and structural cavity problems were infrequent.3 A retrospective study was conducted to evaluate the long-term, anatomic and functional outcome of CWDM performed for chronic otitis media with cholesteatoma and chronic otomastoiditis resistant to all conservative treatment. 1 to 24 years after surgery, cavities were found to be dry and self-cleaning in 95% of cases, and still humid with otorrhea, in 5% of the cases. The study concluded that anatomic and functional results are satisfactory, and the rate of complications is acceptably low provided both patient and the surgeon engage in a long-term follow-up.4 Assessment of 10 year results of CWDM for acquired cholesteatoma in 136 patients showed cholesteatoma recurrence in 23 patients (17%) and after revision the cholesteatoma recurred again in three patients (2% of the total series). 133 (98%) of the ears operated on were dry, two (1%) were moist and one ear (0.7%) was discharging. The tympanic membrane was intact in 125 ears (92%) and perforated in 11 ears (8%). Only 14% of patients had hearing levels of 20 dB or better and 46% had 40 dB or better hearing. There were 7 (5%) totally deaf ears. The author concluded that the surgical technique of CWDM should be improved in order to lower the recurrence rate and to improve hearing results.5 Another study emphasized that rehabilitation of the tympanomastoid cavity is important to achieve a long-standing trouble free cavity and good functional hearing levels. From 1980 to 2004, 1602 CWDM were performed of which 978 had primary surgery and 624 were revision cases. Healing of cavity and tympanic membrane (TM) graft was achieved in 1548 (94.2%) of cases. Revision surgery was performed in 32 cases for recurrence or residual cholesteatoma, mostly in the attic and middle ear. Persisting discharge was present in 12 cases. Serviceable hearing air-bone (A-B) gap closure up to 20 dB was achieved in 1017 (63.5%) cases. Hearing was worse than pre-operative level in 154 (9.6%) cases. There was no improvement in hearing in 397 (24.8%) cases. Serviceable hearing was obtained after second stage ossiculoplasty in 34 (2%) cases. It was concluded that proper post operative follow up, analysis of the failure cases and modifications in standardized procedures are necessary to get a dry ear and serviceable hearing.6 A retrospective review with respect to intraoperative findings in revision canal wall down mastoidectomy showed that the mastoid cavity following primary surgery was found to be dry only in 60% of the cases. Four factors which influenced whether the resulting mastoid cavity would remain dry were: presence of an open middle ear, a large cavity, a high facial ridge and a small meatus. If all four factors were present then the cavity had a 100% chance of discharging. Many cases of revision mastoid surgery have identifiable inadequacies in the primary surgical technique. Attention to key surgical principles should improve the dry ear rate post canal wall down mastoidectomy.7 This study identified what constitutes a problem cavity and techniques to avoid such difficulties. Problem cavity is likely to exhibit a small meatus behind which can be found a high facial ridge, partially removed posterior and superior canal walls, a partially removed lateral attic wall, a deep mastoid tip cavity, no tympanic membrane or a perforation and active mucopurulent drainage. The most common cause of problem cavity was poor execution of open technique.8 6.3 OBJECTIVE OF THE STUDY 1. To identify the cavity problems following canal wall down mastoidectomy. 2. Preventive measures to be taken in the intraoperative and early and late postoperative period to reduce the occurrence of complications, hence the morbidity. 7. MATERIALS AND METHODS 7.1 SOURCE OF DATA The study will include patients of all age groups & either sex undergoing canal wall down mastoidectomy operation in Sri Venkateshwara ENT Institute, Victoria Hospital and Bowring & Lady Curzon Hospitals attached to Bangalore Medical College and Research Institute, Bangalore during the study period from December 2009 to July 2011. 7.2 METHODS OF COLLECTION OF DATA 1. Detailed History taking. 2. Clinical examination. 3. Relevant investigations. 4. Indication for canal wall down mastoidectomy. 5. Postoperative follow up of patients to identify the occurrence of the cavity problems. SAMPLE SIZE: 50 cases undergoing canal wall down mastoidectomy will be included in the study. 7.3 INCLUSION CRITERIA 1. Patients of all age group and either sex. 2. Patients who have undergone canal wall down mastoidectomy. 7.4 EXCLUSION CRITERIA 1. Patients who have undergone canal wall up mastoidectomy Statistical analysis of the data parameters will be done using following statistical tests. 1. Chi-square test. 2. Fisher exact test. 3. Analysis of variance. 7.5 Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so, please describe briefly Yes 1. Complete Haemogram, Bleeding time, Clotting time, Urine Analysis. 2. Random blood sugar, Blood Urea, Serum Creatinine. 3. Chest X-Ray, ECG. 4. Pure Tone Audiometry. 5. Pus for Culture and Sensitivity. 6. X-Ray Mastoid 7. Computed Tomography or Magnetic Resonance Imaging (if necessary). After informing the patients and obtaining prior written informed consent, the patient will be subjected to investigations as indicated and confirmed to well recognized, practiced and established modalities of treatment. No animal study is required. 7.6 Has the ethical clearance been obtained from your institution in case of 7.5? Yes. 8. LIST OF REFERENCES 1. Grewal DS, Hathiram BT, Saraiya SV. Canal wall down tympanomastoidectomy: the 'on-disease' approach for retraction pockets and cholesteatoma. J Laryngol Otol. 2007 Sep; 121(9): 832-9. 2. Nikolopoulos TP, Gerbesiotis P. Surgical management of cholesteatoma: the two main options and the third way- atticotomy / limited mastoidectomy. Int J Pediatr Otorhinolaryngol. 2009 Sep; 73(9): 1222-7. 3. Khalil HS, Windle-Taylor PC. Canal wall down mastoidectomy: A long term commitment to the outpatients? BMC Ear Nose Throat Disord. 2003 Sep 4; 3(1): 1. 4. Kos MI, Castrillon R, Montandon P, Guyot JP. Anatomic and functional long-term results of canal wall-down mastoidectomy. Ann Otol Rhinol Laryngol. 2004 Nov; 113(11): 872-6. 5. Vartiainen E. Ten-year results of canal wall down mastoidectomy for acquired cholesteatoma. Auris Nasus Larynx. 2000 Jul; 27(3): 227-9. 6. Mahadevaiah A, Parikh B, Govindaraj R. Rehabilitation of the Tympanomastoid cavity In Canal Wall Down procedures. Indian Journal of Otolaryngol Head Neck Surg. 2007 Jun; 59(2): 120-123. 7. Phelan E, Harney M, Burns H. Intraoperative findings in revision canal wall down mastoidectomy. Ir Med J. 2008 Jan; 101(1): 14. 8. Glasscock M, Nissen A, Schwaber M, et al: Open mastoid procedures:Contemporary indications and surgical technique. Laryngoscope. 1985; 95: 1037-1043. 9. Signature of Candidate: 10. Remarks of Guide: Cavity problems following canal wall down mastoidectomy are many which may be troublesome to the patients. Hence this study may help us to understand better about the problems and various steps to prevent these and to learn various modalities of treatment of these problems as and when they occur. As this Institution has got all the infrastructure and facilities this study can be undertaken. 11. 11.1 NAME & DESIGNATION OF GUIDE: Dr. M.RAJASHEKHAR MBBS, MS (ENT) Professor of ENT Bangalore Medical College & Research Institute Bangalore: 560002 11.2 SIGNATURE: 11.3 CO-GUIDE (IF ANY) 11.4 SIGNATURE 11.5 HEAD OF THE DEPARTMENT: Dr.H.S. SATISH MBBS, DLO, MS(ENT) Sri Venkateshwara ENT Institute Bangalore Medical College & Research Institute Bangalore: 560002 11.6 SIGNATURE: 12. 12.1 REMARKS OF CHAIRMAN & PRINCIPAL: SIGNATURE: