ANNEXURE I: PROFORMA

Patients identification number as per hospital records:

Age of patient:

Sex:

Brief relevant History:

PREOPERATIVE EVALUATION
1.

Otoendoscopic Examination of perforation:

Size:

Small

Moderate

LEFT

RIGHT

Large

2.

Pure tone audiometry Findings:

Air Conduction:
Bone Conduction:
Air-Bone Gap:

POSTOPERATIVE EVALUATION (After 12 weeks)

1.

Otoendoscopic Examination
Graft uptake: Taken well (YES/NO)
Other findings if any:

2.

Pure tone audiometry:

Air Conduction:
Bone Conduction:
Air-Bone Gap:

PATIENT INFORMATION SHEET AND

INFORMED CONSENT FORM

Study Title: STUDY OF OUTCOMES OF ENDOSCOPIC ASSISTED
TRANSCANAL TYPE 1 TYMPANOPLASTY
Principal Investigator:

Dr. P. KRISHNA SOUMYA REDDY

Guide:

Dr. PRADEEP KUMAR.K.. DLO, DNB

Consultant,
Department of Otorhinolaryngology and Head and Neck
Surgery

Study centre:

Mazumdar Shaw Medical Center

Narayana Health, Bommasandra Industrial Area
Bangalore.

Introduction
I am Dr. P. Krishna Soumya Reddy, Postgraduate trainee in the Department of
ENT at Narayana Hospital. We are doing research on STUDY OF OUTCOMES OF
ENDOSCOPIC ASSISTED TRANSCANAL TYPE 1 TYMPANOPLASTY. I am
going to give you information about the study and invite you to be part of this research.
There may be some words that you do not understand. Please ask me to stop as we go
through the information and I will take time to explain .If you have questions later, you
can ask me or other research team members.

Description of the Process

All adult patients who have chronic otitis media mucosal dry inactive with central
perforation and mild to moderate conductive hearing loss will be examined and
documented.
Purpose of the Study

To study the graft uptake rate.

Evaluate the hearing improvement after endoscopic transcanal type 1

tympanoplasty for small, moderate and large central perforations.

Participant selection
All adult patients in the age range of 18-45 years with chronic otitis media
mucosal dry inactive with central perforation and mild to moderate conductive hearing
loss, who apt for endoscopic procedure.

Voluntary Participation:
Your participation in this research is entirely voluntary. Whether you choose to
participate or not, all the services for patients will continue at standard care and nothing
will change. You are free to refuse your participation in the study or you may withdraw
yourself from the study at any time. Your decision to withdraw from study will not affect
your current or future medical care. Your identity will not be revealed anywhere and all
the measures will be taken to maintain confidentiality.

Study Procedure

Diagnosed patients of chronic otitis media inactive mucosal disease will be

selected and worked up for surgery.

All patients will undergo a thorough head and neck examination prior to surgery

Demographic data, including age and gender will be noted.

Otoendoscopy will be done to note the size of perforation.

Pure Tone Audiometry will performed to know the degree and type of hearing
loss.

Patients will be counselled regarding treatment options i.e. microscopic and

endoscopic tympanoplasty (advantages and disadvantages of each procedure).

Those who opted for endoscopic tympanoplasty only will be included in our
study.

Benefits of the Study

The only direct benefit for you is there wont be any scar behind the ear and it
also will help us find the answer to the research objectives.

Duration of Study
This prospective study will be conducted at Multispeciality Hospital, Narayana
Hrudayalaya from 1st September 2013 to 31st January 2015.

Risk of the Procedure

We might require post aural incision some times to expose mastoid when we find
mucosal active disease, granulation tissue, squamous disease, after elevating the
tympanomeatal flap. Since the procedure done is the routine management protocol for
Chronic otitis media mucosal dry inactive with central perforation and mild to moderate
conductive hearing loss, there will not be any additional risks because of this study.

Compensation
As the study does not involve separate investigations, no compensation will be
offered during the study.

Confidentiality of Records
As a part of the study, the information obtained will be analysed and reported in
an encrypted way. By signing this document you are giving permission to the study
investigator and members of the study staff to use this information in conducting the
study. The overall results of this study may be presented at meeting and in publication,
however your identity will not be revealed in those presentations, in no way your name
will be used in any published form in connection with the result of this study.

Whom to contact
If you have any questions concerning your participation in this study, you should
contact your investigator.
Investigator name: Dr. P. KRISHNA SOUMYA REDDY
Signature:

Date:

Contact number: 7022361953

If you have any questions concerning your rights as a study subject you should
contact ethics committee at:
Narayana Hrudayalaya Medical Ethics Committee,No.258/A,
Bommasandra Industrial Area,
AnekalTaluk, Bangalore-560099.
Contact Person: Dr. S. V. JogaRao, EC Chairperson
Contact Number: +91-(0)-80_32901381

CERTIFICATE OF CONSENT
I have been invited to participate in research of study of outcomes of endoscopic
assisted transcanal type 1 tympanoplasty. I have read the foregoing information, or it
has been read to me. I have had the opportunity to ask questions about it and any
questions that I have asked have been answered to my satisfaction. I consent voluntarily
to participate as a participant in this study. The following has been explained to me in the
language which I understand.

Name of the Participant:

Signature:
Date (D/M/Y):

If Illiterate,
I have witnessed the accurate reading of the consent form to the potential
participant, and the individual has had the opportunity to ask questions. I confirm that the
individual has given consent freely.
Name of the witness

Signature of the witness

Date

and

Thumb Print of the

Participant

Statement by the Researcher/person taking consent:

I confirm that the participant was given an opportunity to ask questions about the
study, and all the questions asked by have been answered correctly and to the best of my
ability. I confirm that the individual has not been forced into giving consent, and the
consent has been given freely and voluntarily.

Name of the Investigator obtaining the consent:

Signature of the Investigator obtaining the consent:

Date: