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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,
KARNATAKA
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
Sl.no
1.
Name of the Candidate and
Dr.V.V. VINAY KUMAR TUMMIDI
Address
TUMMIDI BROTHERS
JAGADAMBA CENTRE,
VISHAKAPTNAM ,
ANDHRA PRADESH.
NAVODAYA EDUCATION TRUST’S
2.
Name of the Institution
NAVODAYA MEDICAL COLLEGE
HOSPITAL AND RESEARCH CENTRE,
RAICHUR- 584103
3.
Course of Study and Subject
POST GRADUATE DEGREE IN
M.S. Otorhinolaryngology (3 YEARS)
4.
Date of Admission to course
31th MAY 201
Title of the topic
A COMPARATIVE EVALUATION OF MYRINGOPLASTY VERSUS
5.
TYMPANOPLASTY TYPE I WITH MASTOIDECTOMY IN PATIENTS
ATTENDING NAVODAYA MEDICAL COLLEGE, RAICHUR.
6.
Brief Resume of the Intended Work
As Ear discharge is one of the
most common complaint encountered by an
otorhinolaryngologist in their day to day practice and most of the
case attributed to Chronic Serous Otitis Media (CSOM) which
are of 2 types- safe and unsafe, out of which safe variety
comprises of infection of mucosa of the middle ear cleft with
discharge and central perforation were taken for the present
study.
The aim of surgical intervention in safe CSOM, being the
restoration of hearing by reconstruction of the central perforation
where the ossicular chain is intact by Myringoplasty or by Type I
Tympanoplasty.
This study evaluates the Effectiveness of cortical mastoidectomy
in terms of hearing and graft uptake when combined with
myringoplasty as compared to myringoplasty alone.
Mastoid cavity buffers the effect of pressure changes in the
middle ear by supplying air to the middle ear. The capacity of
this system is its volume. Increased mastoid pneumatization
enhances the ability to regulate middle ear pressure. The mean
volume of air in the mastoid air cell system could be about 5-8
ml.
The chances of obtaining a dry and self cleaning ear are over
80%, but the success rate varies between cases. Often, the
hearing is worse after mastoidectomy, since the goal is primarily
to eradicate the disease, rather than preserve hearing. However,
occasionally the hearing may improve as well. Hearing
reconstruction is often delayed because it is necessary to rebuild
the bones of hearing at a future date.
Normal mastoid air cell system is an air reservoir and also an
active cavity having gas exchange capability independent of
Eustachian tube. Air cell system is capable of gas exchange by
sub mucosal capillary network Because gas exchange occurs in
cellular mucosa, total area of mucosal surface affects gas
exchange rate. It has been shown that mastoid cellular system
works like an air reservoir. When the air volume changes in the
middle ear, mastoid air cell system minimize the effects of
pressure changes by adding air to the middle ear. Thus it
works like a pressure buffering system. Therefore in well
pneumatized ears, the buffering function is doing more
efficiently.
6.1
Need for the Study:
The Purpose of this study is to ascertain whether the
mastoidectomy should be combined as a standard operating
procedure for Type I Tympanoplasty in safe type of chronic
suppurative otitis media, so as to achieve the near normal
physiology of the ear and to lessen the graft rejection rate.
6.2
Review of Literature:
The first myringoplasty, including removal of epithelium and
grafting of skin was done by Berthold in 1878. Blake in 1887
used a paper patch for perforations of the tympanic membrane,
and Joynt proposed the use of cautery and patches for defect of
the drumhead in 1919.¹
Prior to introduction of antibiotics mastoidectomy for acute
inflammatory disease In 1649, Riolanus first described mastoid
surgery to relieve obstruction of the eustachian tube and tinnitus,
and Petit in 1736 was the first to perform successfully a mastoid
operation for mastoiditis.¹
Ortegren in 1967 presented a paper on the result of
myringoplasty carried out since 1957 by various eminent
otologists like Zollner, Wright, Heerman et al etc. based on the
extensive study he concluded that connective tissue grafts i.e.
fascia are superior to skin grafts in myringoplasty and the results
of myringoplasty performed on patients above 40 years were not
so good as those below this limit. He also noticed that
reperforations within occurred 6 months in most cases at follow
up and the role of mastoid cellularity in myringoplasties were not
clear in these studies.2
Of all these grafting materials, the most effective have been
those from connective tissue. While each type of graft has its
own advocates, the temporalis fascia graft is by far the most
popular and has become the standard to which all other materials
are compared today.3
Holmquist and others studied 31 cases of chronic otitis media.
The ears were selected preoperatively on the basis of the size of
mastoid air cell system and function of the eustachian tube. They
concluded that there is a need to have an air reservoir connected
with the middle ear for the treatment of patients with poor tubal
function. Therefore, obliteration of the mastoid cavity in middleear surgery should be avoided.4
Wehrs and others observed that in order to achieve a good
hearing result following tympanoplasty, it is necessary to
maintain an aerated middle ear space.5
Poor Eustachian tube function is most commonly blamed in
cases of failure to obtain an adequately aerated middle ear
following tympanoplasty. Although this may be the true
aetiology in some cases, middle ear adhesions, loss of support of
the posterior canal wall and inadvertent blockage of the
eustachian tube orifice by graft material may be contributing
factors. Aeration of the mastoidectomy cavity is also important to
prevent collapse of the posterior canal wall, retraction pockets
and ensure an adequate air reserve.5
The most limited form of chronic inflammatory ear disease is the
perforated tympanic membrane, which usually does not require
mastoid operation. The most prevalent form of disease is chronic
otitis media with otorrhoea but no cholesteatoma.6
Hegde and colleagues did a prospective study which consisted of
100 patients with unilateral middle ear pathologies over a period
of 24 months. Bilateral x-ray mastoids (laws view) were taken
for all the patients. The area was measured by using planimetry.
They observed a statistically significant difference in the area of
the diseased ears in chronic suppurative otitis media
tubotympanic type of duration less then 5yr and more than 5 year
groups but not in the healthy sides. This proves that there is a
definite relation between the area of the mastoid air cells and the
duration of the middle ear disease. They concluded that the
decreased pneumatization in patients with middle ear disease is
secondary to the chronic inflammation and not due to otitis
media in infancy or congenital causes. Hypocellularity is an
affect but not the cause of middle ear pathologies. This study
proved that there is a definite relation between the area of the
mastoid air cells and the duration of middle ear disease.7
Yung studied hearing gain in relation to the perforation site. He
included the patients who had an intact tympanic membrane one
year following the surgery. One hundred perforations of the
tympanic membrane with successful myringoplasties were
reviewed. A partially reversible impairment of bone conduction
was noted, being more obvious in posterior and subtotal
perforations. It was also shown that the site of perforation affects
the degree of hearing loss and the degree of subsequent
improvement after myringoplasty, marginal and malleolar
perforations had a greater hearing loss and less post operative
hearing improvement then central and non malleolar perforations
8
. It was also shown that posterior perforations had a greater
hearing loss then anterior perforations.9
Sharp Terzis and Robinson studied in 47 patients with either an
anterior or subtotal perforation of tympanic membrane extending
up to the anterior annulus margin.10
Their experience with Kerr flap, an underlay graft fashioned to
include a tag of fascia which is placed laterally under the annulus
and the anterior meatal skin, is presented. This method gave a
97.5% closure rate with no cases of anterior marginal blunting
and a mean auditory threshold gain of 8.5dB was achieved at the
frequencies tested. They concluded that use of the Kerr flap is
recommended when repairing the anteriorly placed tympanic
membrane perforation.10
Emmett studied 260 cases of Type I tympanoplasties to
determine whether age is a factor in healing. He concluded that
age is not a factor in success or failure of healing following
tympanoplasty surgery.11
How the size of the temporalis fascia alters with its state of
hydration was reported by England, Strachen and Buckley. The
size of 20 temporalis fascia grafts were measured when fresh and
again after flattening and allowing them to dry, and finally after
rehydrating the grafts with 0.9% saline solution. They noted
significant shrinkage. They proposed that the cause of increased
failure rates, particularly in anterior myringoplasties, is the loss
of underlay due to graft rehydration and shrinkage. Thus they
concluded that graft shrinkage should be considered when
positioning the graft.12
Tympanoplasty with or without mastoidectomy is indicated for
chronic ear disease process such as tympanic membrane
perforation resulting from previous middle ear infections.13
6.3
Objective of the Study:
1. To evaluate the surgical outcomes of myringoplasty in
comparison of Type I Tympanoplasty and mastoidectomy in
terms of improvement in Hearing and graft uptake
2. To know how far mastoidectomy is needed in safe type of
chronic suppurative otitis media.
3. To form a common consensus regarding the surgical
management of chronic suppurative otitis media.
7.
7.1
Materials and Methods:
Prospective study of 60 patients attending the ENT OPD of
Navodaya Medical College and Research Centre with history of
ear discharge and clinical examination who were diagnosed as
Chronic Suppurative Otitis media were taken for the present
study for a period of one and half years from October 2012 to
July 2014.
Method of collection of Data :
7.2
Study Area: Hospital Based (Navodaya Medical College
Hospital and Research Centre)
Design of study: A Prospective Study.
Sampling technique: 60 Patients selected on Simple Random
Selection Technique.
Sample collection study shall include 60 patients with history
of ear discharge, attending ENT outpatient department in
Navodaya medical college hospital and research centre, Raichur
over a period of one half years from October 2012 to July 2014.
This study includes 60 patients of Chronic Suppurative Otitis
Media safe type in Inactive or Quiescent stage. All these cases
will be operated during a period of one and a half years from
October 2012 to July 2014 in the Department of ENT, Navodaya
medical college.
A detailed history followed by Complete clinical examination
will be undertaken and the patients were randomly grouped in to
Group A and Group B consisting of 30 cases each.
30 cases (Group A) will be selected for myringoplasty alone and
30 cases (Group B) will be selected for type 1 tympanoplasty
with cortical mastoidectomy.
Inclusion Criteria:
1. Age>15 years and <60years.
2. Tubotympanic type of CSOM central, subtotal perforation.
3. Mild and moderate Conductive hearing loss.
4. Eustachian Tube should be patent.
5. Quiescent and Inactive Stage of CSOM.
Exclusion criteria:
1. Age <15years and> 60 years.
2. Atticoantral type of CSOM marginal and attic perforation.
3. Profound hearing loss.
4. Previous major ear surgery.
5. Eustachian Tube Obstruction.
6. Patient with Sensorineural Hearing Loss.
7. Active Stage of Infection of the Ear.
8. CSOM with intracranial Complications.
Data Analysis:
Data collected will be entered on excel spread sheet after coding
and further processed using SPSS Version 17.0 (Statistical
package for social sciences). The data analysis will be done by
computing proportions, mean of standard deviation. Appropriate
test of significance will be used based on type of data.
A p value <0.05 will be considered significant.
Does the study require any investigation or intervention or
7.3
investigation to be conducted on patients or other humans
and animals?
Yes , My study involves Investigation like Hemoglobin, Total
count, Differential leucocyte Count, Erythrocyte Sedimentation
Rate, Bleeding time, Clotting time, Random Blood Sugar, Blood
Urea, Serum Creatinine, Urine Routine
Special Investigations like Bilateral Mastoid X-ray, Pure Tone
Audiometry, Diagnostic Otoendoscopy, Computed Tomography
Scan .
Surgery: Examination under microscope, Myringoplasty or
Tympanoplasty Type I with Cortical Mastoidectomy.
Has Ethical Clearance been obtained from your institution in
7.4
case of 7.3?
YES, Ethical Clearance been obtained from the institution.
8
List of References:
1. Otolaryngology By- Paperalla, Shumrick, Gluckman, Meyerhoff, 3rd
Edition,
Volume 2, Pg- 1410.
2. Ortegren. Myringoplasty. Acta Otolaryngology. Suppl: 193, 1-41.
3. Rizer FM. overlay versus underlay Tympanoplasty. Part 1: Historical
review of
the literature. Laryngoscope. 1997; 107: 1-23.
4. Holmquist J and Bergstrom B. The mastoid air cell system in ear
surgery. Arch
otolaryngology.1978; 104:127-9.
5. Wehrs RE, Tulsa OK. Aeration of the middle ear and mastoid in
tympanoplasty.
Laryngoscope. 1981; 91: 1463-7.
6. Otolaryngology Head and Neck Surgery By- Charles W Cummings,
John M
Fredrickson, Lee A Harker, Charles J Krause, Mark A Richardson, David
E
Schuller, 3rd edition, Volume 4, Pg-3120.
7. Hedge MC, Kamath MP, Kumar S, Kumar A and Chandra S. A study
of mastoidcellularity and middle ear diseases. Indian Journal of
Otolaryngology. 2004; 10:6-9.
8. Yung MW. Myringoplasty: Hearing gain in relation to perforation site.
1983;
97: 11-7.
9. Adkins WY, White B and Charleston SC. Laryngoscope. 1984; 94:
916-8.
10. Sharp JF, Terzis TF and Robinson J. Myringoplasty for the anterior
perforation:
Experience with Kerr flap. Journal of Laryngology and Otology. 1992;
106: 14-6.
11. Emmett JR. Age as a factor in the success of tympanoplasty: A
comparison of
outcomes in the young and old. ENT – Ear, Nose and Throat Journal.
1999; 78:
480-3.
12. England RJ, Strachan DR and Buckley JG. Temporalis fascia graft
shrink. The
Journal of Laryngology and Otology. 1997; 111: 707-8.
13. Surgery of the Ear by- Glascock and Gulya, 5th Edition, Volume 3,
Pg-229.
(6):592-5.
9.
Signature of the candidate
10.
Remarks of the Guide
RECOMMENDED AND
FORWARDED
11.
11.1 Name And Designation of Guide
Dr. S R HEGDE
PROFESSOR AND HEAD
DEPARTMENT OF ENT,
NAVODAYA MEDICAL
COLLEGE, RAICHUR
11.2 Signature
11.3 Co-Guide (if any)
11.4 Signature
11.5 Head of Department
Dr. S R HEGDE
PROFESSOR AND HEAD
DEPARTMENT OF ENT,
NAVODAYA MEDICAL
COLLEGE, RAICHUR
11.6 Signature
12
12.1 Remarks of Chairman and
Principal.
12.2 Signature
STUDY SUBJECT CONSENT STATEMENT
TITLE OF THE STUDY: A COMPARATIVE EVALUATION OF
MYRINGOPLASTY VERSUS TYMPANOPLASTY TYPE I WITH
MASTOIDECTOMY IN PATIENTS ATTENDING NAVODAYA MEDICAL
COLLEGE, RAICHUR.
GUIDE: DR. SR HEGDE
HOD AND PROFESSOR OF ENT
PG STUDENT
Dr.V.V. VINAY KUMAR TUMMIDI
NAVODAYA MEDICAL COLLEGE
RAICHUR
I confirm that investigator has explained to me the purpose of study,
study procedure that I will undergo and possible risks and discomforts as well as
benefits that I may experience in my own language. I understand this study
consists of exposure to radiation and invasive procedures. I understand that
medical information produced by this will be subjected to confidentiality. I have
been explained all the above in detail in my own language and I understand the
same. Therefore, I agree to give my consent to participate as a subject in the
research project.
Signature of witness
subject
Date:
Signature of the
Date: