RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA.
ANNEXURE - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS / DR. ASHWINI GODSE
PG IN ENT,
KIMS, HUBLI - 580022.
2. /

Name of the institution

/ KARNATAKA INSTITUTE OF MEDICAL SCIENCES, HUBLI-580022
3. / Course of the study and subject / M.S. ENT.
4. / Date of admission to the course / 16 /05/2012
5. /
Title of the topic
/ “CORRELATION OF OUTCOME OF TYMPANOPLASTY BY MICROSCOPIC METHOD AND ENDOSCOPIC METHOD”
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, hence treating CSOM with surgical treatment by tympanoplasty is one of the common procedure in ENT.
The introduction of the operating microscope has significantly enhanced the outcome of tympanoplasty by improving the accuracy of the technique. The operating microscopy provides a magnified image in straight line, hence the surgeon can’t visualize the deep recesses of the middle ear in single operating field. This is overcome by use of rigid endoscope for tympanoplasty. In rigid endoscopy view is better but surgeons 2 hands are not free so manipulation here is difficult.Very few studies have been conducted till date to correlate the outcomes of microscopic and endoscopic tympanoplasty such as
Post operative stay.
% of graft uptake.
Postop air bone gap improvement.
Hence this is study to compare the outcomes of tympanoplasty by conventional microscopic method and endoscopic method
Review of Literature:
1.  Yadav s.p, s.agarwal et al studied about the endoscopic assisted myringoplasty.endoscopic assisted myringoplasty was carried out in 50 patients aged 18-45 yr, using temporalis fascia graft. Over all graft uptake and improvement in conductive deafness as air bone gap closure was achieved in 80% of cases, they concluded that endoscpic myringoplasty is equally effective , less morbid,very cost effective in smaal central perforation, however it is not effective in large perforation.
2.  A study conducted by Raj A, Mehar R on endoscopic transcanal myringoplasty and compare the outcomes with that of myringoplasty using microscope , showed that graft uptake is 90% in endoscopic method and 85% in microscopic method but there was no significant differences between the gain in the air bone gap in either group.Study was done on 40 patients. These 40 patients were devided into 2 equal groups of 20 patients each.
3.  Study conducted by Harugop AS, Mudhol RS,Godhi A, on A comparative study of endoscopy assisted myringoplasty and microscopy assisted myringoplasty done between 2003 to 2006 concluded that surgery with endoscope has several advantages and few disadvantages. Surgical outcome of endoscopy assisted myringoplasty was comparable to the conventional microscopic assisted myringoplasty but in terms of cosmesis post-operative recovery the patient in endoscope group had better result.
4.  Karchuketo TS studied the tympanoscope assisted myringoplasty.30 ears of 29 patients with different sized perforation underwent endoscope assisted myringoplasty. In their study concluded that the post operative air bone gap was less than 10 dB in 90% cases. Hence tympanoscope assisted myringoplasty is reliable and simple procedure with the benefit of minimal trauma to the healthy tissue.
5.  Badr el dine M studied the value of endoscopy in cholesteatoma surgery and concluded that incorporating the endoscope into the surgical procedure contributes much to the concept of minimally invasive surgery. Minimally invasive endoscopic ear surgery should be accepted as a new horizon in ear surgery. In this study it became obvious that despite the use of endoscope in conjuction with the operating microscope, 100% eradication of the disease still could not be achieved, however the use of endoscopes did reduce the residual cholesteatoma rate.
6.  Kakachata, seizi et al studied the endoscopic transtympanic tympanoplasty in the treatment of conductive hearing loss.study concluded that as opposed to conventional methods, the endoscopic method doesnot require surgical exposure such as otosclerotic drilling and skin incision and avoids the substantial risk of unnecessary injury to chorda tympani. Endoscopic transtympanic tympanoplasty for disrupted ossicular chain is an adequate and minimal invasive procedure and should prove to be an useful surgical procedure in future endoscopic tympanoplsty.
7.  Muaaz Tarabichi studied the endoscopic transcanal middle ear surgery and concluded that the wide angle view provided by the endoscopes enables trans-canal access to the tympanic cavity, attic,sinus tympani,facial recess and hypotympanum.these areas are the primary sites of the disease and surgical failure to cure.
8.  Tarabichi Muaaz studied the trascanal endoscopic management of cholesteatoma and concluded that Endoscopic management of cholesteatoma allows the use of the ear canal as the direct and natural access point to cholesteatoma within the mesotympanum, attic, facial recess, sinus tympani, hypotympanum, and eustachian tube. It does not improve access to mastoid disease.
9.  B. Fabinyi;C. Klug studied, a minimally invasive technique for endoscopic middle ear disease and concluded that Middle ear endoscopy should be considered a useful adjunctive or alternative method to microscopic surgical exploration for middle ear pathology. This minimally invasive technique provides excellent visualization for viewing the surgical micromorphology and pathological findings of the middle ear. Selected patients underwent middle ear endoscopy using a transtympanic approach. Rigid endoscopes of 2.7 mm and 1.9 mm caliber and 0°, 30° and 70° viewing angles were introduced into the tympanic cavity through small tympanostomy incisions.
OBJECTIVES OF THE STUDY:
1.  To study the merits and demerits of endoscope assisted tympanoplasty.
2.  To study the merits and demerits of microscope assisted tympanoplasty.
3.  To co-relate the outcomes of the above two procedures such as
Duration of surgery
Post operative stay
% of graft uptake
Improvement in A-B gap
7. / Materials and methods:
7.1 Source of data:
All patients attending the out-patient department of ENT, KIMS who had satisfied the inclusion criteria mentioned below during the study period of 1 year from November 2012 to December 2013.
7.2 METHOD OF COLLECTION OF DATA:
SAMPLE SIZE:40
STUDY DESIGN AND SAMPLING
This will be a randomised prospective correlative study.All the eligible patients who satisfied the inclusion criteria mentioned below are recruited into the study.Otoscopic examination and tuning fork tests, and pre operative PTA will be done to know the perforation,degree of hearing loss, air bone gap.pre op routine investigations will be done.Patients are randomly selected either for endoscopic tympanoplasty or for the microscopic tympanoplasty. Post operative outcomes such as % of graft uptake,improvement in hearing, air bone gap closure,post op hospital stay in two groups are measured and correlation between two wil be done.
Appropriate statistical test will be used to analyse the data of the two groups as the need arises.
INCLUSION CRITERIA:
Subjects with tympanic membrane perforation due to CSOM or trauma
Subjects with conductive hearing loss due to CSOM or trauma
Subjects with inactive and quiescent CSOM
Age between 15-60 year
EXCLUSION CRITERIA:
·  Patients with active discharge
·  Patients with mastoiditis
·  Patient with sensorineural hearing loss
·  Patients with cholesteatoma
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR
INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR
OTHER HUMANS OR ANIMALS? IF SO DESCRIBE BRIEFLY.
Yes.
·  Routine pre op blood investigations such as Hb,BT,CT,HIV, HBS Ag
·  Pre operative PTA
·  Post operative PTA
·  X ray mastoid
·  Otomicroscopy and otoendoscopy
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.  Yadav S P S, Aggarwal N, julaha M, Goel M. endoscope assisted myringoplasty Singapore med J 2009; 50(5):510-512.
2.  Raj A, Meher R Endoscopic transcanal myringoplasty-a study Indian journal of otolaryngology and head and neck surgery jan-mar vol 53, issue 1, pp 47-49.
3.  Harugop A S, Mudhol R S,Godhi A, comparative study of endoscope assisted myringoplasty and micrsoscope assisted myringoplasty Indian Journal of Otolaryngology and Head & Neck Surgery December 2008,Volume 60,Issue 4,pp 298-302
4.  Karhuketo TS, Ilomäki JH, Puhakka HJ Tympanoscope-Assisted Myringoplasty ORL 2001;63:353–358
5.  Badr-el-Dine, M otology and neurology sep 2002-volume 23-issue 5 PP-631-635.
6.  Kakehata S,Futai K,Sasaki A,Shinkawa H., Endoscopic transtympanic tympanoplasty in the treatment of conductive hearing loss: early results. Otol Neurotol.2006 Jan;27(1):14-9.
7.  Muaaz Tarabichi, Endoscopic transcanal middle ear surgery: Indian J Otolaryngol Head Neck Surg. 2010 January; 62(1): 6–24.
8.  Tarabichi, Muaaz, Transcanal Endoscopic Management of Cholesteatoma Otology & Neurotology: June 2010 - Volume 31 - Issue 4 - pp 580-588.
9.  B. Fabinyi;C. Klug , a minimally invasive technique for endoscopic middle ear surgery European Archives of Oto-Rhino-Laryngology Volume 254, Supplement 1S53-S54
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE / SATISFACTORY
11. / 11.1 NAME AND DESIGNATION OF THE GUIDE / DR. UMESH S.NAGALOTIMATHMS,DNB.
PROFESSOR AND HEAD,
DEPARTMENT OF ENT, HEAD and NECK SUGERY,
KIMS, HUBLI.
11.2 SIGNATURE
11.3 HEAD OF THE DEPARTMENT / DR.UMESH S. NAGALOTIMATHMS,DNB
PROFESSOR AND HEAD,
DEPARTMENT OF ENT, HEAD and NECK SURGERY,
KIMS, HUBLI.
11.4 SIGNATURE
12. / 12.1 REMARKS OF THE CHAIRMAN AND THE PRINCIPAL
12.2 SIGNATURE