ANNXEURE-1
TITLE:
“COMPARATIVE
STUDY
OF
IMPROVEMENT
OF
NASAL
SYMPTOMS FOLLOWING SEPTOPLASTY WITH PARTIAL INFERIOR
TURBINECTOMY VERSUS SEPTOPLASTY ALONE IN ADULTS BY NOSE
SCALE - A PROSPECTIVE STUDY.”
PROFORMA FOR DATA COLLECTION
A.
PERSONAL DETAILS
1.
Name
:
2.
Age
:
3.
Sex
:
4.
Occupation and Income
4.
Father’s/Husbands name
:
5.
I.P. No.
:
9.
DOA:
10.
Address (Postal & Mobile no):
B.
QUESTIONNAIRE FOR HISTORY TAKING
Chief Complaints
History of Present Illness
Personal History
Treatment History
Family History
Past History:
:
DOD:
1.
Nasal obstruction/blockage :
a)
Duration of obstruction :
b)
Side of obstruction :
c)
Diurnal variation :
2.
Snoring :
3.
Mouth breathing :
4.
Difficulty sleeping :
5.
Nasal discharge (purulent/mucoid) :
6.
Excessive sneezing /allergy :
7.
Post nasal discharge :
8.
Hyposmia/anosmia
9.
Headache :
10.
Bleeding from nose :
11.
Halitosis :
12.
Dental pain
13.
Facial pain
13.
Cough :
14.
Ear pain/ fullness :
15.
Any other associated symptom :
16.
Treatment history :
:
:
:
C. EXAMINATION OF EAR, NOSE AND THROAT:
Nose
External nose
Nasolabial Fold
Vestibule
Anterior Nares
Anterior rhinoscopy
Nasal cavity
Nasopharynx
Choana
Posterior rhinoscopy
PNS tenderness
Oral CavityMouth – Vestibule
Mouth Proper
Uvula
Soft Palate
Throat
Anterior pillar
Posterior pillar
Tonsils
Posterior pharyngeal wall
IDL :
Hypopharynx
Ear
Preauricular region
Pinna
Post auricular region
External Auditary Canal
Tympanic Membrane
Otoscopy
Tuning fork test
D.
SYSTEMIC EXAMINATIONS: -
CVS
RS
CNS
PA
NECK EXAMINATION
E.
INVESTIGATIONS
1.
Plain X ray Paranasal sinuses:
2.
Diagnostic nasal endoscopy (before surgery)
Right
Left
Right
Left
Septum
Turbinates
Airway
Ostiomeatal complex
a. Mucosal hypertrophy
b. Inflammation
c. Erythema
d. Pathologic secretion
e. Anatomic or Mucosal
abnormalities
3.
Routine blood investigation
4. Absolute eosinophil count:
F.
DIAGNOSIS:
•
SURGERY DONE :
H.
POST OPERARIVE TREATMENT:
Date :
I. HISTOPATHOLOGICAL EXAMINATION OF INFERIOR
TURBINATE( IN
PATIENT WHO HAVE UNDERGONE TURBINATE REDUCTION)
FOLLOW UP
J. DIAGNOSTIC NASAL ENDOSCOPY 1 MONTH AFTER SURGERY
Date:
Right
Left
Right
Left
Septum
Turbinates
Airway
Ostiomeatal complex
a. Mucosal hypertrophy
b. Inflammation
c. Erythema
d. Pathologic secretion
e. Anatomic or Mucosal
abnormalities
K. DIAGNOSTIC NASAL ENDOSCOPY 3 MONTHS AFTER SURGERY
Date :
Right
Left
Right
Left
Septum
Turbinates
Airway
Ostiomeatal complex
a. Mucosal hypertrophy
b. Inflammation
c. Erythema
d. Pathologic secretion
e. Anatomic or Mucosal
abnormalities
L. DIAGNOSTIC NASAL ENDOSCOPY 6 MONTHS AFTER SURGERY
Date :
Right
Left
Right
Left
Septum
Turbinates
Airway
Ostiomeatal complex
a. Mucosal hypertrophy
b. Inflammation
c. Erythema
d. Pathologic secretion
e. Anatomic or Mucosal abnormalities
Annexure-2
QUESTIONNAIRES
NAME OF THE PATIENT:
GROUP: A/B
I.P NO. :
DATE :
AGE:
SEX:
NASAL OBSTUCTION SYMPTOMS EVALUATION SCALE (NOSE)
BEFORE SURGERY/1MONTH AFTER SURGERY/3MONTHS/ 6MONTHS AFTER
SURGERY
NASAL
CONGESTION
NASAL
BLOCKAGE OR
OBSTRUCTION
TROUBLE
BREATHING
THROUGH
MY
NOSE
TROUBLE
SLEEPING
UNABLE TO GET
ENOUGH
AIR
THROUGH
MY
NOSE
DURING
EXERCISE
OR
EXERTION
NOT
A VERY
MODERATE
PROBLEM MILD
PROBLEM
PROBLEM
0
1
2
FAIRLY
BAD
SEVERE
PROBLEM
3
4
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
0
1
2
3
4
Annexure-3
Written Informed Consent Form
Informed consent form for the volunteers who will be participating in the research project (MS
dissertation) entitled : “COMPARATIVE STUDY OF IMPROVEMENT OF NASAL
SYMPTOMS FOLLOWING SEPTOPLASTY WITH PARTIAL INFERIOR
TURBINECTOMY VERSUS SEPTOPLASTY ALONE IN ADULTS BY NOSE
SCALE - A PROSPECTIVE STUDY.”
Name of Principal Investigator
Dr. Rajendran Dinesh Kumar,
Postgraduate student
Name of Organization
Department of ENT,
Navodaya Medical College Hospital and
Research Centre, Raichur.
This Informed Consent Form has two parts:
•
Information Sheet (to share information about the research with you)
•
Certificate of Consent (for signatures if you agree to take part)
You will be given a copy of the full Informed Consent Form
PART I: Information Sheet
Introduction
I, Dr. Rajendran Dinesh Kumar, postgraduate student in the Department of ENT, Navodaya
Medical College Hospital and Research Centre, Raichur, am working on my MS dissertation
titled “COMPARATIVE STUDY OF IMPROVEMENT OF NASAL SYMPTOMS
FOLLOWING SEPTOPLASTY WITH PARTIAL INFERIOR TURBINECTOMY
VERSUS SEPTOPLASTY ALONE IN ADULTS BY NOSE SCALE - A
PROSPECTIVE STUDY”.
I am going to give you information and invite you to be part of this research. You do not have to
decide today whether or not you will participate in the research. Before you decide, you can talk
to anyone you feel comfortable with about the 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 them and
get yourself clarified.
Purpose of the research
Deviation of nasal septum towards one side is often associated with an over growth of inferior
turbinate, which occupies expansive space of contralateral nasal cavity. The enlargement of
inferior turbinate can be due to mucosal elements or bony expansion. Many authors argued once
septoplasty is done compensatory hypertrophy regresses on its own while other group of authors
argued that these changes are not spontaneously reversible and should be corrected in
conjunction with nasal septal surgery. Otherwise surgery may relieve the obstruction on one side
of nose but leave other side obstructed, because of relocation of septum towards hypertrophied
turbinate. Numerous medical descriptions are available regarding the pathology and treatment of
the deviated nasal septum, however none of these descriptions have highlighted a complete
surgical management of this condition to improve nasal airway. Many otolaryngologists perform
septoplasty with or without turbinate surgery based largely on clinical judgment. So by doing
this study we want to find out whether reduction of inferior turbinate hypertrophy is necessary
or not and whether septoplasty alone can treat nasal obstruction in patients with deviated nasal
septum.
Type of Research Intervention
In this study if you are selected, detailed history taking and clinical examination will be done.
Plain X-ray PNS and diagnostic endoscopy, routine investigation will be performed. Surgery
would be done either reduction of hypertrophied inferior turbinate with septoplasty or
septoplasty alone either under local anesthesia or general anesthesia.
Participant selection
All patient above 18 years of age presenting to ENT department with history of nasal obstruction
for atleast 3 months and clinically diagnosed to have deviated nasal septum with inferior
turbinate hypertrophy.
Procedures and Protocol
Patients with septal deviation and contralateral inferior turbinate hypertrophy will be recruited in
the study. Detailed history and clinical examination will be done.
Patients need to fill
questionnaires relating to severity of their symptoms using Nasal Obstruction Symptom
Evaluation (NOSE) scale. Patients will then be randomly divided into two groups. In group A,
reduction of inferior turbinate will be performed to treat hypertrophied inferior turbinate together
with septoplasty. In group B, only septoplasty will be performed. Post-operative patient's
symptoms will again be evaluated using Nasal Obstruction Evaluation Scale (NOSE) at 1,3 and 6
month and compared with preoperative findings.
Duration: 1 ½ year.
Voluntary Participation
Your participation in this research is entirely voluntary. It is your choice whether to participate or
not. Whether you choose to participate or not, it will not affect your patient’s treatment process.
Benefits
Personally you might be or may not be benefited in any way directly from the research. But by
taking part in this research, you will be helping the scientific community to learn more about
whether septoplasty alone can treat nasal obstruction in patient with deviated nasal septum and
whether reduction of inferior turbinate is necessary or not.
Possible risks
There is minor physical risks for the person associated with these methods. Risks involves
related to complications associated with surgery or anesthesia. Complications will be explained
in your own language in which you understand prior to surgery.
Reimbursements
You won’t be given any monetary incentives or gifts for being a part of this research.
Confidentiality
The information that we collect from this research project will be kept confidential. Information
about the patient that will be collected during the research will be put away and no-one but the
researchers will be able to see it.
Sharing the Results
The knowledge that we get from doing this research will be shared with you. Confidential
information will not be shared. We will publish the results in order that other interested people
may learn from our research.
Right to Refuse or Withdraw
You do not have to take part in this research if you do not wish to do so. You may also stop
participating in the research at any time you choose. It is your choice and all of your rights will
still be respected.
Who to Contact
This proposal has been reviewed and approved by the Research and Ethical committee of
Navodaya Medical College Hospital and Research Centre, Raichur, which is a committee whose
task it is to make sure that research participants are protected from harm.
You can ask me any more questions about any part of the research study, if you wish to. Do you
have any questions?
PART II: Certificate of Consent
I have read the foregoing information, or it has been read to me. I have been explained the two
modalities of treatment and both are meant for relieving my nasal obstruction. I have been
explained the procedure and complications. I am willing to undergo surgery in either of the
groups. 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
research.
Name of Participant_________________________
Signature of Participant ___________________
Date: __________________________________ (day/month/year)
If illiterate a literate witness must sign (if possible, this person should be selected by the
participant and should have no connection to the research team). Participants who are illiterate
should include their thumb-print as well.
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 witness_________________
Thumb print of participant
Signature of witness _____________
Date ________________________
Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant, and to the best of my
ability made sure that the participant understands that the following will be done:
1. Blood investigations:
•
Hb, TC, DC, ESR, RBS, BT, CT, Blood group, Blood Urea, Serum Creatinine,
HIV, HbsAg, HCV, AEC.
2. Chest x- ray (PA view) and X-ray PNS Water’s view, CT PNS.
3. Diagnostic nasal endoscopy
4. E.C.G
5. Urine routine
6. Anesthesia: General or local anesthesia
7. Surgery: Septoplasty with reduction of hypertrophied inferior turbinate or septoplasty alone.
I confirm that the participant was given an opportunity to ask questions about the study, and all
the questions asked by the participant have been answered correctly and to the best of my ability.
I confirm that the individual has not been coerced into giving consent, and the consent has been
given freely and voluntarily.
A copy of this informed consent from has been provided to the participant.
Name of Researcher/person taking the consent_______________________
Signature of Researcher /person taking the consent_____________________
Date ___________________________
Day/month/year