Rajiv Gandhi University of Health Sciences, Bangalore s6

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA,

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE Dr. GIRISH.P.B. AND ADDRESS (IN BLOCK POST GRADUATE LETTERS) DEPARTMENT OF OTORHINOLARYNGOLOGY AND HEAD AND NECK SURGERY, J.J.M. MEDICAL COLLEGE, DAVANGERE , KARNATAKA 2. NAME OF THE INSTITUTION J.J.M. MEDICAL COLLEGE, DAVANGERE – 577 004, KARNATAKA.

3. COURSE OF STUDY AND MEDICAL SUBJECT M.S. IN OTORHINOLARYNGOLOGY AND HEAD AND NECK SURGERY.

4. DATE OF ADMISSION TO 16-08-2012 COURSE

5. TITLE OF THE TOPIC “COMPARATIVE STUDY OF DIFFERENT MYRINGOPLASTY TECHNIQUES FOR ANTERIOR LARGE AND SUBTOTAL PERFORATIONS OF CHRONIC SUPPURATIVE OTITIS MEDIA OF TUBOTYMPANIC TYPE”.

6. BRIEF RESUME OF THE INTENDED WORK :

6.1 Need for the study :

Myringoplasty is a surgical procedure to repair the tympanic membrane perforation. There are two established techniques of Myringoplasty, overlay technique and underlay technique. In overlay technique we place the graft lateral to the fibrous layer of the tympanic membrane. In underlay technique we place the graft medial to the tympanic membrane remnant. Underlay technique is the most common and easiest technique, is typically used for posterior perforations, where as the overlay technique is more technically challenging and particularly suited for anterior large or subtotal perforations.

1 If the perforation is in the anterior half of the tympanic membrane or if the perforation is subtotal, then underlay tympanoplasty may fail because the anterior edge of the graft falls away from and fails to adhere to the anterior remnant of the tympanic membrane. Although overlay technique has higher success rate for the reconstruction of anterior large or subtotal tympanic membrane perforations, serious complications including anterior angle blunting, graft lateralization, epithelial pearls and delayed healing may occur. In order to achieve greater success with graft uptake, hearing improvement, and prevention of complications, there are many modifications in underlay technique. In this study we have taken three of these modified techniques for correcting anterior large and subtotal tympanic membrane perforations in chronic otitis media of tubotympanic type. The selected techniques are 1) anterior tagging technique,2) circumferential sub annular grafting technique and 3) cuff technique.

6.2 Review of literature :

J.F. Sharp etal did 47 cases with anterior or subtotal perforation of pars tensa and found in kerr flap technique graft uptake was 95.7% and hearing improved by an average 8.5 dB1 Farhad Mokhtarinejad etal did 38 cases (group- A) circumferential sub annular grafting and 25 cases (group-B) of underlay tympanoplasty with extension of anterior edge of the graft forward against the lateral wall of the Eustachian tube, they found success rate in 97% in group-A and 100% in group B patients, improvement of the air conduction thresholds in all frequencies and closure of the mean air bone gap were significant and similar among two groups 2. Prakash mishra, did prospective study of 100 cases of underlay technique with superiorly based circumferential flap it was found that graft take up was 97%, hearing gain of 10-30 dB was achieved in 95% of cases.3 Abolhassan Faramarzi etal did 45 patients with subtotal or total tympanic membrane perforation and inadequate anterior remnant. Underwent “mucosal pocket” Myringoplasty. They found the graft success rate of 91.1% without lateralization, blunting, atelectasia,or epithelial pearls. Approximately 24% patients had AB gap within 25 dB before intervention which has increased to 71% post operatively. 4

2 Jay B Farrior, did 499 patients with sandwich graft technique shows 98% graft uptake. 5 Scott schraff etal did 164 patients with anterior marginal perforation with window shade technique shows graft uptake 94.5% and AB gap within 10dB in 82%,ABgap within 20 dB in 16%,ABgap within 30dBin 2%. 6 P Hosmani etal did 33 patients with anterior tagging Myringoplasty(group A) and 27 patients without anterior tagging(group B),showed graft uptake was 96.96%in group A and 81.5% in group B and concluded with anterior tagging of graft material is a suitable for anterior and subtotal perforations.7 Mangal Singh etal did 60 cases with perforations of both subtotal and large central perforations of pars tensa and found underlay technique is easier and less time consuming than overlay technique. They also found those patients receiving overlay technique had less gain in hearing (57.1%) as compared to those receiving underlay techniques, graft up taking in both techniques were same (93.3%). 8 Giovanni Ralli, conducted Myringoplasty for perforations of pars tensa and found underlay technique improves in hearing and helps in maintain an air containing middle ear space. 9 Karansingh yadav done retrospective study of modified full cuff technique found graft uptake was 95.4% and hearing has improved in all patients and concluded that this technique is easier and less time consuming. This technique can be taught to beginners. 10 P.Packer compared different techniques on 1065 cases overlay technique graft uptake rate is 88%,in underlay it is 92%,hearing has improved in underlay technique(70%) than overlay(47%) and also found underlay technique is easier and quicker.11 Arunabha etal done prospective study on 40 patients among which in underlay technique done in 16 (40%), overlay technique in 14(35%) and combined technique in10 (25%) patients. They found that graft uptake is equal in techniques and in hearing AB gap reduced in 85%,overall success rate among three methods did not vary significantly.12 Dennis G etol did 108 cases with annular wedge tympanoplasty technique was found that 97% graft uptake rate. 13

3 Dinesh Kumar Sharma etol did 90 cases of Myringoplasty with temporalis fascia graft by underlay or overlay technique through one of the three approaches, permeatal, end aural and post-aural was found 81.11% graft uptake and air bone gap of 26-35dB in 36.66% and 36-45dB in 63.34% of cases.14 Marcielle A. Ghanem etol did 99 cases of butterfly cartilage inlay grafts were retrospectively analysed and found 92% graft uptake rate and the hearing improved to 0- 20dB in 52% of cases. 15 Chopra H. etol did 40 cases between 16-50yrs found that graft uptake with overlay technique in anterior perforations was 85.71%,central perforation 87.5%,as compared to underlay technique in posterior perforations 100% and subtotal perforations 100%.16 Khaled M.etol studied 85 cases. These were classified into three groups; group ‘A’(30 cases) where 0.2mm thickness cartilage graft was used, group‘B’ (30 cases) repaired with full thickness cartilage graft and group‘C’(25 cases) where temporalis fascia graft was used, and found graft uptake is 100% in group A&B, and 60% in group C,and air bone gap decreased in group A 29.7 to 9.9 and in group B 29.3 to 13.8 and in group C 28.9 to 9.3.17 Imre Gerlinger.etol studied 46 cases with KTP-532 laser assisted myringoplasties was found that graft uptake was 100%.18 Jack M Kartush.etol studied 120 cases with over-under tympanoplasty was found 100% graft uptake, and overall the mean air bone gap decreased by 5.3+11.3dB.19 M ILangovan did 40 cases with combined approach tympanoplasty was found graft uptake was 97.5% and hearing improved to 20-40dB.20 Balasubramanian Thiagarajan etol did 50 Myringoplasty using endoscope was found that graft uptake at the end 1stweek is 36 and at the end of 4thweek is 42 cases and hearing improvement from 30-40dB to 20dB. 21 Gian Antonio Bertoli,etol did 73 patients with Fat Myringoplasty was found that graft uptake in posterior perforations was 90.5% and in anterior perforations it was 67.7%.22 Wen–Hung wang.etol did retrospective study of 48 tympanoplasties in 46 patients,28 inlay and 20 underlay procedure, was found graft uptake in inlay and underlay were 82.1% and 85%, and mean air bone gap were 6.3dB and 9.3dB respectively.23

4 Glasscock etal did 1556 underlay technique of which he found graft uptake was 93%, Sheehy did 472 overlay technique found 97% success rate, Vartiainen, did 404 combined technique found 88% graft uptake.24 Paul R Lambert etal studied various Myringoplasty techniques and found by Brackmann <10-15dB in 63% and <20-25dB in 79%,Grote <10-15dB in 62% and <20- 25dB in 83%,Reck & Helms <10-15dB in38% and <20-25dB in 76%,Wehrs <10-15dB in 72% and <20-25dB in 90%,Lesinski <10-15dB in 68% and <20-25dB in 88% hearing improvement.25

6.3 Objectives of the study :

1. To assess the graft uptake, hearing improvement before and after Myringoplasty and associated complications in each technique.

7. Material and methods

7.1 SOURCE OF DATA

This is a comparative study on patients attending as outpatient and inpatient at Department of OTORHINOLARYNGOLOGY AND HEAD AND NECK SURGERY J.J.M.Medical College Davanagere.

Sample size-100

7.2 METHOD OF COLLECTION OF DATA

 Detailed history will be taken followed by clinical examination.

 Selected patients will be investigated by doing Tuning fork tests, Pure Tone Audiometry before and after Myringoplasty.

 Follow up patient after 1st month, 3rd month and 6th month is once again tested for Pure Tone Audiometry and graft uptake.

INCLUSION CRITERIA

 Chronic suppurative otitis media of tubotympanic type with Anterior large and subtotal perforations

 Age group of patients 15 to 60 years and both the sexes.

5 EXCLUSION CRITERIA

 Cases of chronic suppurative otitis media of atticoantral type,  Cases of chronic suppurative otitis media with ossicular discontinuity.  Cases of chronic suppurative otitis media with extensive disease requiring exteriorizing procedure like modified radical Mastoidectomy.

7.3 Does the study require any investigations or interventions to be Conducted on patients or other humans or animals?

 Tuning fork tests

 BLOOD: Haemoglobin, Total count, Differential count, absolute eosinophil count, ESR, bleeding time, clotting time, random Blood Sugar, HIV, HBs Ag, blood urea, serum creatinine  Urine routine examination  Ear discharge culture and sensitivity  X ray mastoids  Examination under Microscope.  Pure Tone Audiometry.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

8. List of References 1. J.F. Sharp, T.F.Terzis,J.Robinson “Myringoplasty for the anterior perforation :experience with the Kerr flap” the journal of laryngology and otology .1992 Jan, vol 106,pp14-16 2. Farhad Mokhtarinejad,Seyyed Ahmad Reza okhovatFarzaneh Barzegar “surgical and hearing results of the circumferential sub annular grafting technique in

6 tympanoplasty randomized clinical study” American journal of otolaryngology-head and neck medicine and surgery 2012;33; 75-79

3. Prakash Mishra, Nishi Sonkhya, Naveent Mathur. “Prospective study of 100 cases of underlay tympanoplasty with superiorly based circumferential flap for subtotal perforations” Indian J Otolaryngol. Head neck surg .2007(July-sept) 59:225- 228 4. Abolhassan Faramarzi,Seyed Basir Hashemi,Ahmadreza Razaee “mucosal pocket Myringoplasty modification of underlay technique for anterior or subtotal perforations” American journal of otolaryngology-head and neck medicine and surgery xx(2012) xxx-xxx 5. Jay B ,Farrior, “sandwich graft tympanoplasty:experience,result,and complications” laryngoscope 1989 Feb, 99 pp 213-217 6. Scott Schraff,Nariman Dash, Barry Strasnick “window shade tympanoplasty for anterior marginal perforations” laryngoscope 2005 sep;115; pp1655-1659 7. P Hosmani,L Ananth,S B Medikeri “comparative study of efficacy of graft placement with and without anterior tagging in type one tympanoplasty for mucosal- type chronic otitis media” journal of laryngology and otology ,2012Feb; issue02;vol 126; pp125-130 8. “Man gal Singh, Ash tosh Rai, Sarmishtha Bandopadhyay, Gupta.S.C.” comparative study of the underlay and overlay techniques of Myringoplasty in large and subtotal perforations of the tympanic membrane” . The journal of laryngology & otology.2003 June, vol 117,pp 444-448 9. Giavanni Ralli, Jacqueline crupi, Guiseppe Nola, Marco de vincentiis. “Anchored Myringoplasty for total perforation with malleus adhesion to the promontory”. Laryngoscope 2000 April; vol 110; pp 674-679 10.Karan Singh yadav, Rajeev Nerurkar. “Abstracts of papers presented at the 187th research meeting of the medical research centre of Bombay hospital trust on Monday 14th Dec. 2010-modified technique of full cuff tympanoplasty”. Bombay Hospital Journal, 2012,No.1;vol 54 1. P. Packer, A. Mackendrick, and M. Solar. “What’s best in Myringoplasty: underlay or overlay, dura or fascia?” The Journal of Laryngology and Otology.1982 Jan, vol 96, pp 25-41. 2. Arunabha sengupta, Bijan Basak, Debasis Ghosh, Deepjoy Basu, Debasish

7 Adhikari, Kuntal Maity. “A study on outcome of underlay overlay and combined techniques of Myringoplasty” Indian j Otolaryngol Head neck surg.2012 Jan- March 64(1):63-66 3. Dennis G.Pappas, L.clark Simpson, “Annular wedge tympanoplasty” Laryngoscope 1992 October; vol 102; 1192-1197. 14.Dinesh Kumar Sharma, Sunder Singh, Barjinder Singh shoal ,Baldev Singh “Prospective study of Myringoplasty using different approaches” Indian J Otolaryngol Head Neck Surg, 2009(October-December) vol, 61;297-300 15.Marcielle A.Ghanem,Angelo Monroy,Farmarz S.Alizadeh,Yamileth Nicolau, Roland D.Eavey, “Butterfly cartilage graft inlay tympanoplasty for large perforations” Laryngoscope 2006October ; vol 116;1813-1816. 16. Chopra H., Munjal M., Mathur N. “Comparison between overlay and underlay techniques of Myringoplasty” Indian Journal of otology,2001, vol 7,no 2,83-85 17. Khaled M. Mokbel M. Thabet. “repair of subtotal tympanic membrane perforation by ultrathin cartilage shield; evaluation of take rate and hearing results” Eur Arch

Otorhinolaryngol DOI;10,1007/s00405-011-1903-5. 18. Imre Gerlinger. Gabor Rath., Istvan Szanyi., Jozsef Pytel “Myringoplasty for anterior and subtotal perforations using KTP -532 laser”. Eur Arch Otorhinolaryngol (2006)263; 816-819. 19. Jack M.Kartush,Elias M.Michaelides, Zoran Becvarovski, Michael J.LaRouere, “Over - under tympanoplasty” Laryngoscope 2002,May; vol112; pp802-807. 20. M.Ilangovan. “Myringoplasty in total / subtotal perforation” Indian Journal of otolaryngology 1986,December;vol 38; no 4; pp5-6 21. Balasubramanian Thiagarajan., Venkatesan Ulaganathan., “Endoscope assisted Myringoplasty” Otolaryngalogy online journal; 2012 vol 2; supplement 1 2012. 22.Gian Antonio Bertoli,;Marco Barbaro,;Valerio Giangrande,;Gianluca Bava,;Elio De Seta,; Roberto Filipo, “Fat graft Myringoplasty; An official procedure for the repair of small perforations of the tympanic membrane” The Mediterranean Journal of otology 2007; vol 3 ;pp120-125.

8 23. Wen-Hung Wang, Yen-Chun Lin, “Minimally invasive inlay and underlay Tympanoplasty” American Journal of otolaryngology –Head and Neck Medicine and Surgery 29(2008)363-366. 24. Glosscock-Shambough (2003) surgery of the ear, 5th edition, pp 400-415 25. Charles. W .Cummings; Otolaryngology Head and neck surgery 2ndedition,; 2978-2987 26. Scott-Brown’s Otorhinolaryngology, Head and neck surgery,7thedition,vol 3; 3421-3422

9. SIGNATURE OF CANDIDATE

9 10 REMARKS OF THE GUIDE This is a good study to know the better technique to improve graft uptake in anterior large and Subtotal perforations of tympanic membrane. 11 NAME & DESIGNATION Dr. A. M. MALLIKARJUNAPPA OF (IN BLOCK LETTERS) PROFESSOR 11.1 Guide DEPARTMENT OF OTORHINOLARYNGOLOGY AND HEAD AND NECK SURGERY, J.J.M. MEDICAL COLLEGE, DAVANGERE - 577 004.

11.2 Signature

11.3 Co-Guide (if any) - -

11.4 Signature - -

11.5 Head of Department Dr. K.V. LOKANATH PROFESSOR AND HEAD, DEPARTMENT OF OTORHINOLARYNGOLOGY AND HEAD AND NECK SURGERY, J.J.M. MEDICAL COLLEGE, DAVANGERE - 577 004.

11.6 Signature

12 12.1 Remarks of the Chairman & Principal

12.2. Signature.

10 Approval of Ethics Committee To Dr. GIRISH.P.B. POSTGRADUATE, DEPARTMENT OF OTORHINOLARYNGOLOGY & HEAD & NECK SURGERY J.J.M. MEDICAL COLLEGE, DAVANGERE.

The Institutional Ethics Committee, J.J.M. Medical College, Davangere has reviewed and discussed your application to conduct the study/dissertation entitled

Title: “COMPARATIVE STUDY OF DIFFERENT MYRINGOPLASTY TECHNIQUES FOR ANTERIOR LARGE AND SUBTOTAL PERFORATIONS OF CHRONIC SUPPURATIVE OTITIS MEDIA OF TUBOTYMPANIC TYPE”

The following documents were reviewed : a. Trial Protocol (including protocol amendments), dated ______Version no. (s). ______(not applicable). b. Patient information sheet and Informed Consent form (including updates if any) in English and/or vernacular language. (yes) in Vernacular language. c. Investigator’s Brochure, dated ______, Version no. ______(not applicable). d. Proposed methods for patient accrual including advertisement (s) etc. proposed to be used for the purpose. (not applicable) e. Principal Investigator’s current CV. f. Insurance Policy / Compensation for participation and for serious adverse events occurring during the study participation (not applicable)

g. Investigators agreement with the sponsor. (not applicable)

h. Investigators Undertaking (Appendix VII) (not applicable).

We approved the study to be conducted in its presented form.

The Institutional Ethics Committee, J.J.M. Medical College, Davangere expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information/ informed consent and asks to be provided a copy of the final report.

Your sincerely,

Member Secretary, Ethics Committee Chairman/Vice Chairman Ethics Committee

J.J.M. MEDICAL COLLEGE, DAVANGERE DEPARTMENT OF OTORHINOLARYNGOLOGY AND HEAD AND NECK SURGERY INFORMED CONSENT

I ______the undersigned hereby give my consent for the investigations and medical treatment given to me. I am satisfied with the information given about this clinical study titled “COMPARATIVE STUDY OF DIFFERENT MYRINGOPLASTY TECHNIQUES FOR ANTERIOR LARGE AND SUBTOTAL PERFORATIONS OF CHRONIC SUPPURATIVE OTITIS MEDIA OF TUBOTYMPANIC TYPE” being conducted by Dr. GIRISH. P. B., under the guidance of Dr. A.M.MALLIKARJUNAPPA, M.S., Professor, Department of OTORHINOLARYNGOLOGY AND HEAD AND NECK SURGERY. I have been informed and explained the risk involved and I hereby voluntarily and unconditionally give my consent without any fear or pressure, in mentally sound and conscious state to participate in this study.

Patient signature Date :

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