NARENDRA MODI MEDICAL COLLEGE

INSTITUTIONAL REVIEW BOARD

DISSERTATION TITLE:

“A COMPARITIVE STUDY OF TEMPORALIS FASCIA GRAFT AND

TRAGAL CARTILAGE GRAFT IN TYPE 1 TYMPANOPLASTY IN
CHRONIC SUPPURATIVE OTITIS MEDIA”

NAME OF THE DEPARTMENT : OTORHINOLARYNGOLOGY

NAME OF THE STUDENT : DR. MUSKAN VIRENDRA MEHTA

NAME OF PG TEACHER : DR. HIREN DOSHI

NAME OF HEAD OF THE DEPARTMENT : DR.HIREN DOSHI

CONTACT NUMBER OF STUDENT : +91 9033399273

CONTACT NUMBER OF PG TEACHER : +91 99245 75751

DATE & SIGN OF PG TEACHER:

DATE & SIGN OF HEAD OF THE DEPARTMENT

 INTRODUCTION:

• Tympanic membrane is a membranous partition separating the external auditory

meatus from the tympanic cavity measuring 9-10 mm vertically and 8-9 mm
horizontally. Tympanic membrane perforation is caused by variety of causes, the
most common being trauma and infections. Trauma (Barotrauma, temporal bone
fracture), infections (Acute otitis media, Chronic otitis media, TB), iatrogenic
(ventilation tubes).[1]

• Inactive Mucosal chronic otitis media is defined as permanent perforation of the

pars tensa but the middle ear and mastoid are not inflamed.[2]

• Tympanoplasty is "a procedure to eradicate disease in middle ear and to reconstruct

the hearing mechanism, with or without tympanic membrane grafting".[3]

• It is important to diagnose and treat tympanic membrane perforation as early as

possible as untreated tympanic membrane perforation leads to ongoing destructive
changes in the middle ear, thus adding to further hearing loss. Tympanic membrane
perforation leads to varying degree of conductive hearing loss.[4]

• Loss of hearing is a national health problem with significant physical and psycho
social problem. [4]

• Several graft materials have been used for tympanic membrane repair such as
temporalis fascia, tragal cartilage and perichondrium, conchal cartilage, fascia lata
etc. [5]

• Using temporalis fascia as graft, there is a good improvement in hearing and

higher tympanic membrane closure rate. However this approach is associated with
physical scar and long term numbness around the ear after surgery. [6]

• Cartilage offers the advantage of higher mechanical stability compared with

membranous transplant thus preventing retraction of tympanic membrane in long
run. [7]

• The greatest advantage of cartilage grafts was initially thought to be their very
low metabolic rate. However, this tissue can receive nutrition by diffusion; it is
easy to work with because it is pliable and can resist deformation by pressure
variations. The major advantage of cartilage grafts is their stiffness and
bradytrophic metabolism. [8]
 AIMS AND OBJECTIVES

• To compare the efficacy in terms of graft uptake or graft displacement between

temporalis fascia graft and tragal cartilage graft groups.

• To compare the efficacy in terms of audiological outcomes - pure-tone

audiometry results preoperatively and postoperatively, between temporalis fascia
graft and tragal cartilage graft groups.

METHODOLOGY

STUDY DESIGN:

Hospital based prospective study.

INCLUSION CRITERIA:

● All patients diagnosed clinically with mucosal type of chronic otitis media.
● Age of more than 12 years .
● Patients with dry ear.
● Patient willing to give consent for study and surgery.
● Type 1 Tympanoplasty

EXCLUSION CRITERIA :

● Patient with active disease / pure sensorineural hearing loss / squmosal type of
chronic otitismedia .
● History of previous ear surgery,systemic disease which may affect the ear
(collagen vascular or granulomatous diseases).
● Patient not fit for surgery.

STUDY PLACE:

ENT Department, LG Hospital, Narendra Modi Medical College, Ahmedabad.

STUDY DURATION:

October 2023 to May 2026

MATERIALS AND METHODS:

• All patients fulfilling the inclusion criteria will be included in the study.

• The patients are allocated to the two study groups randomly, considering the
inclusion and exclusion criteria. The patients who underwent tympanoplasty
with tragal cartilage were included in Group A and patients who underwent
tympanoplasty with temporalis fascia graft were included in group B.

• A detailed clinical history to be obtained and a complete otorhinolaryngologic

and systemic examination will be performed.

• Preoperative audiometry will be performed in all patients.

• A preoperative haematological and radiological assessment of patient will be

performed.

• Surgery will be performed for the respective group (Group A Tympanoplasty

with tragal cartilage graft, Group B tympanoplasty with temporalis fascia graft)
by the surgeon.

• Post operative follow up examinations 1 week, 1 month and 3 months and

PTA would be done for all patients at post op 1 months and 3 months
duration.

• Results will be analyzed using appropriate statistical methods.

STATISTICAL ANALYSIS:

Appropriate statistical methods will be applied on the collected data base.

PROPOSED PUBLICATION PLANS:

The study will be used for publication after completion of my dissertation and attainment
of my M.S ENT Degree, in the indexed journal.

ETHICAL ASPECTS:

Consent of the patients to participate in the study (format enclosed) will be taken and its
confidentiality will be maintained.
 CONSENT FORM

I _______________________________________________________, the undersigned,

have been explained about the study “A COMPARITIVE STUDY OF TEMPORALIS
FASCIA GRAFT AND TRAGAL CARTILAGE GRAFT IN TYPE 1
TYMPANOPLASTY IN CHRONIC SUPPURATIVE OTITIS MEDIA”. At Sheth L.G.
General Hospital, Ahmedabad.
I understand that this study includes collection of data related to my disease and
treatment given to me. I have been given affirmation that confidentiality of all data,
photographs and identity will be maintained and they may be used for the purpose of
publication and education.

I hereby give my consent to be included in the study.

Signature of Participant : Signature of Researcher :

Signature of witness : Date :

 સંમતીપત્રક

મને __________________________________________________,નીચે

હસ્તાક્ષરિત, “ ક્રોનનક સુપ ૂિે રિવ ઓિાઇરિસ મીરિયામાાં િાઇપ 1 રિમ્પેનોપ્લાસ્િીમાાં

િેમ્પોિાલલસ ફેનિયા ગ્રાફ્િ અને ટ્રેગલ કારિિલેજ ગ્રાફ્િનો તુલનાત્મક અભ્યાસ“ નવિે

સમજાવવામાાં આવ્ુાં છે . િેઠ એલ.જી. જનિલહોસ્સ્પિલ, અમદાવાદ.

હુ ાં સમજુ ાં છાં કે આ અભ્યાસમાાં માિા િોગ અને મને આપવામાાં આવેલી સાિવાિ

સાંબનાં િત િેિાના સાંગ્રહનો સમાવેિ થાય છે . મને ખાતિી આપવામાાં આવી છે કે

તમામ િેિા, ફોિોગ્રાફ્સ અને ઓળખની ગુપ્તતા જાળવવામાાં આવિે અને તેનો

ઉપયોગ પ્રકાિન અને નિક્ષણના હેત ુ માિે થઈ િકે છે .

હુ ાં આથી અભ્યાસમાાં સામેલ થવા માિે માિી સાંમનત આપુાં છાં.

દદીની સહી : સાંિોિકની સહી :

સાક્ષીની સહી : તાિીખ :

 सहमतिपत्र

मैं____________________________________________________________

_________________________को अध्ययन “क्रोननक सपरु े टिव ओटिटिस मीडिया

में िाइप 1 टिम्पेनोप्लास्िी में िे म्पोरललस फेलियाग्राफ्ि और ट्रै गल काटििलेज ग्राफ्िका

तुलनात्मक अध्ययन “ के बारे में बताया गया है। िेठ एल.जी. अस्पताल, अहमदाबाद।

मैं समझता हूं कक इस अध्ययनमें मेरी बीमारी और मझ

ु े टदए गए उपचारसे सूंबूंधित

िेिाका सूंग्रह िालमल है । मुझे आश्वासन टदया गया है कक सभी िेिा, तस्वीरों और

पहचानकी गोपनीयता बनाए रखी जाएगी और उनका उपयोग प्रकािन और लिक्षाके

उद्देश्यसे ककया जा सकता है।

मैं इस अध्ययनमें िालमल होने के ललए अपनी सहमनत दे ता हूं।

मरीज़ के हस्ताक्षर : सुूंिोिक के हस्ताक्षर :

साक्षी के हस्ताक्षर : तारीख :

 PROFORMA

History taken by:

History given by:

• Name:

• Age:

• Sex:

• Residence :

• Occupation:

• Phone Number:

• Indoor registration Number:

• Date of Admission:

• Date of Operation:

• Date of Discharge:

COMPLAINTS

EAR DISCHARGE : Yes / No

Side : Right / Left / Both

Duration : ……………...Months / Year

Amount : Scanty / Moderate / Profuse

Colour : Yellowish / White / Green

Consistency : Watery / Mucoid / Purulent / Mucopurulent

Blood stained : Yes / No

Foul Smelling : Yes / No

Aggravating factors :

Reliving factors :

Associated with : Decreased Hearing / Tinnitus / Other complaints

EAR ACHE : Yes / No

Side : Right / Left / Both

Duration :………..………Months / Years

Type of Pain : Dull-aching / Throbbing

Severity of Pain : Mild / Moderate / Severe

Aggravating factors :

Relieving factors :

Associated with :

DECRASED HEARING : Yes / No

Side : Right / Left / Both

Duration :………………..Months / Years

Degree of hearing loss : Mild / Moderate / Severe

Decreased hearing at time of Discharge : Yes / No

Associated with:

VERTIGO : Yes / No

If Yes then since how long :………………..Months / Years

Type of Vertigo:

Vertigo with Deafness or not :

Associated with Neck movement : Yes / No

TINNITUS : Yes / No

Since how long :....................Months / Years

Type of Tinnitus :

Unilateral / Bilateral :

AUTOPHONY :

FACIAL SYMMETRY :

NOSE :

NASAL BLOCKAGE : Yes / No

Duration :

Unilateral / Bilateral :

Occasional / Persistent :

Relieving / Aggravating factor :

NASAL DISCHARGE : YES / NO

Duration :

Unilateral / Bilateral :

Consistency :
OTHER COMPLAINTS

PAST HISTORY

History of Hypertension / DM / TB / Jaundice /Any major illness

History of Similar Surgery / Any Surgery

History of Blood Transfusion

History of Hospitalization

History of Immunocompromised state like HIV-AIDS / Malignancy

FAMILY HISTORY

History of Hypertension / DM / TB / Jaundice / Any major illness

PERSONAL HISTORY

Diet :

Appetite :

Bowel :

Bladder :

Addiction :

H/O Drug reaction :

H/O Allergy :

MENSTRUAL HISTORY

LMP:
GENERAL EXAMINATION

Built / Nourishment

VITAL DATA

Temperature :

Pulse :

Blood Pressure :

Respiratory Rate :

SIGNS

Pallor :

Icterus :

Cyanosis :

Clubbing :

Pedal Oedema :

GENERALIZED LYMPHADENOPATHY
LOCAL EXAMINATION

EAR

Pre auricular Region :

Pinna :

Post auricular Region :

Tragal Tenderness :

Mastoid Tenderness :

External Auditory Canal :

Tympanic Membrane :

Tuning Fork Test :

RINNE TEST

WEBER TEST

ABSOLUTE BONE CONDUCTION TEST

Fistula test :

Facial Nerve Examination :

NOSE

External Appearance :

Vestibule :

Anterior Rhinoscopy :

1. Septum :
2. Floor :
3. Mucosa :
4. Cavity :
5. Inferior Turbinate :
6. Middle Turbinate :
7. Middle Meatus :
8. Discharge :
9. Polyp :
10. Mass :
11. Bleeding :
12. Crusts :
13. Pus :

Posterior Rhinoscopy :

Para nasal sinus Tenderness :

ORAL CAVITY

Tongue :

Floor of Mouth :

RetromolarTrigone :

Teeth :

Hard Palate :

Buccal Mucosa :

Gum :
OROPHARYNX

Anterior Pillar :

Tonsil :

Posterior Pillar :

Soft Palate :

Uvula :

Base of Tongue :

Posterior Pharyngeal wall :

INDIRECT LARYNGOSCOPY

NECK

PROVISIONAL DIAGNOSIS
PRE-OPERATIVE

INVESTIGATIONS

HEMATOLOGICAL

1. Hemogram:

2. Blood Sugar:

3. Bleeding Profile:

4. Renal Function Test:

5. Liver Function Test:

6. Blood Group Cross Matching:

7. HIV:

8. HbsAg:

ECG:

RADIOLOGICAL FINDING

Chest X ray (PA View):

X ray Mastoid:
AUDIOLOGICAL:

Pure Tone Audiometry:

INTRAOPERATIVE:

Type of Graft Material:

OT NOTE:

POST OPERATIVE:

Ear Examination

At 1 week:
At 1 month:
At 3 months:

● Graft Uptake

● Graft displacement

Pure Tone Audiometry

At 1 months

At 3 months
 REFERENCES:

1. Donaldson JA, Duckert LG (1991) Anatomy of the ear. In: Paparella MM,
Shumrick DA (eds) Otolaryngology. Basic sciences and related principles,
3rdedn. WB Saunders Company, Philadelphia

2. Scott brown otorhinolaryngology head and neck surgery 8th edition chapter
83;980

3. Glasscock shambaugh 6th edition chapter 28; page 465-488

4. Pannu K, Chadha S, Kumar D (2011) Preeti: Evaluation of Hearing Loss in

Tympanic Membrane Perforation. Indian J Otolaryngol Head Neck Surgery
63(3):208-2

5. Jain A, Samdani S, Sharma MP, Meena V. Island cartilage vs temporalis fascia

in type 1 tympanoplasty: a prospective study.
ActaOtorrinolaringoEsp.2018;69(6):311-317 doi: 10.1016/j.otorri.2017.10.004

6. Myringoplasty With an Ultrathin Cartilage-Perichondrium Complex Graft

Versus Temporalis Fascia Graft: A Propensity Score-Matched Analysis Yi-Bo
Huang, MD, PhD1*, Lu-lu Hu, MD2*, Dong-Dong Ren, “hD1, and Zhao Han,
MD, PhD3Otolaryngology-Head and Neck Surgery 1-7Ó American Academy of
Otolaryngology-Head and Neck Surgery Foundation2020Reprint. And
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7. Comparison of results of graft uptake using tragal cartilage perichondrium

composite graft versus temporalis fascia in patients undergoing surgery for
chronic otitis media – squamous type.S Khalilullah1, Shankar P. Shah2*, D.
Yadav3, R. P. Shrivastav4 and H 3hattarai4.Khalilullah et al.Head& Face
Medicine(2016) DOI 10.1186/s13005-016-0123-z

8. Levinson RM. Cartilage-perichondrial composite graft tympanoplasty in the

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