Post Graduate in Department ENT

From,

Dr Shruti Manjunath

Post Graduate in Department ENT,

A.J. Institute of Medical Sciences,

Mangalore- 575004

To,

The Registrar,

RajivGandhiUniversity of Health Sciences,

Bangalore

(Through proper channel)

Sub: Submission of Synopsis of Dissertation

Respected Sir,

Herewith, I am submitting synopsis of my dissertation work: “A COMPARATIVE STUDY ON THE OUTCOME OF FUNCTIONAL ENDOSCOPIC SINUS SURGERY BETWEEN SMOKERS AND NON SMOKERS WITH CHRONIC RHINOSINUSITIS AND / OR NASAL POLYPS” for the registration in Rajiv Gandhi University of Health Sciences, Bangalore.

Thanking you,

Yours faithfully,

Dr Shruti Manjunath

Place: Mangalore

Date:

CURRICULUM VITAE

Name:Dr. Shruti Manjunath

Date of Birth:July 28th, 1988-25 Years

Present Designation : Junior Resident

Department:ENT

College :A.J.Institute of Medical Science

City:Mangalore

Residential Address:Residents Quarter’s No – 309

AJIMS Campus,

Kuntikana, Mangalore

Ph & Fax No with code:Office : 0824– 2225533

Mob No : 9901653153

Email Address :

Date of joining present Institution:June 5th, 2012 as Junior Resident

Qualification:

Qualification / College / University / Year / Registration No of UG & PG with date / Name of the State Medical Council
MBBS / JSSMedicalCollege, Mysore / RajivGandhiUniversity of Health Sciences / March
2012 / Reg no. -94498 Date- March 2012 / Karnataka Medical Council

Details of the previous appointments / teaching experience

Designation / Department / Name of Insttution / From DD/MM/YY / To
DD/MM/YY
PG/Jr Resident / ENT / A.J.Institute of Medical Sciences, Mangalore / June 5th, 2013 / Till date

CURRICULUM VITAE

Name:Dr.Kavitha Ashok Kumar

Date of Birth:March 3, 1974 – 39Years

Present Designation : Professsor

Department:ENT

College :A.J.Institute of Medical Science

City:Mangalore

Residential Address:“Rathna Jyothi” plot No – 47

Dr.Shivaram Karanth Nagar Layout,

Konchady, Mary Hill

Mangalore

Ph & Fax No with code:Office : 0824– 2211876

Residence : 0824 6565641

Mob No : 9448102341

Email Address :

Date of joining present Institution:Sept 01, 2010 as Professor

Qualifications:

Qualification / College / University / Year / Registration No of UG & PG with date / Name of the State Medical Council
MBBS / J.N.MedicalCollege, Belgaum / KarnatakaUniversity / Feb 1998 / 48, 391
Date: Feb 21, 1998 / Karnataka Medical Council
MS (ENT) / J.N.MedicalCollege, Belgaum / RGUHS Bangalore / Sept 2001 / 48,391
Date: May 28, 2003 / Karnataka Medical Council
DM/M.Ch / NA / NA / NA / NA / NA

Details of the previous appointments / teaching experience

Designation / Department / Name of Insttution / From DD/MM/YY / To
DD/MM/YY / Total Experience in years & months
PG/Resident / ENT / J.N.MedicalCollegeBelgaum / Sept 1998 / Aug 2001 / 3 Years
Assistant Professor / ENT / Fr.MullerCollege, Mangalore / Apr 01, 2002 / Mar 31, 2007 / 5 Years
Associate Profesor / ENT / Fr.MullerCollege, Mangalore / Apr 01, 2007 / Aug 31, 2010 / 3 Years 5 Months
Professor / ENT / A.J.Institute of Medical Sciences, Mangalore / Sept 01, 2010 / Till date / 3 years 2 months

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE.

ANNEXURE II

SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / NAME OF THE CANDIDATE AND ADDRESS / DR. SHRUTI MANJUNATH
POSTGRADUATE STUDENT
DEPT OF ENT
A.J.INSTITUTE OF MEDICAL SCIENCES
MANGALORE- 575004
2 / NAME OF THE INSTITUTION / A.J.INSTITUTE OF MEDICAL SCIENCES
MANGALORE- 575004
3 / COURSE OF STUDY AND SUBJECT / MS COURSE IN ENT
4 / DATE OF ADMISSION TO COURSE / 5th JUNE 2013
5 / TITLE OF THE TOPIC / A COMPARATIVE STUDY ON THE OUTCOME OF FUNCTIONAL ENDOSCOPIC SINUS SURGERY BETWEEN SMOKERS AND NON SMOKERS WITH CHRONIC RHINOSINUSITIS AND/OR NASAL POLYPS
6 / BRIEF RESUME OF INTENDED WORK:
6.1. NEED FOR THE STUDY:
Chronic Rhinosinusitis is characterized by the inflammation of the mucosa of the nose and paranasal sinuses of atleast 12 consecutive weeks’ duration.
The two main aetiologies include 1. Any anatomical obstruction to the sinus ostia and 2. defective mucocilliary clearance due to which the sinuses are unable to
drain adequately. As a result, normal nasal secretions become trapped in the sinuses
and become chronically infected.
Functional endoscopic sinus surgery is a procedure designed to open the natural
drainage pathways of the sinuses. The goal of the surgery is to carefully remove the
thin bone and mucous membranes blocking the drainage pathways of the sinuses.
Mucociliary transport is the main defense mechanism of the respiratory tract against
pathogens and toxins, both in the upper and lower airways.However, it should be
noted that the efficiency of transport may vary in different conditions, such as
exposure to harmful particles of cigarette smoke.
In vitro and in vivo studies have shown that exposure of the ciliated epithelium to
particles of cigarette smoke results in a significant decrease in ciliary beat
frequency. Studies byCohen et al. and Stanley et al showed that ciliary beats were
diminished as a result of exposure to tobacco smoke, thus impairing mucociliary
clearance and mucociliary transport was slower in regular
smokers . It is also suggested that the exposure of nasal
mucosa to cigarette smoke varies considerably depending on the type of cigarette and
whether the smoke is exhaled by the nose or mouth.
Heat and toxic elements may directly destroy ciliary cells. Tobacco smoke can cause
irritation and inflammation.
Production of cytokines, including interleukin-5, interleukin-8, and granulocyte-
macrophage colony-stimulating factors
are suspected to be a primary cause of inflammation of the sinuses. It is also believed
that patients who continue to smoke following surgery will
receive minimal benefit from surgery and are more likely to require revision surgery.
The outcome of Functional Endoscopic Sinus Surgery in smokers will be assessed
here and will be compared to the outcome in non-smokers. As most of the research in
this field has been done outside the Indian subcontinent, this study will help to
assessthe effects of cigarette smoking on the outcome of Functional Endoscopic
Sinus surgery in our setup.
6.2.REVIEW OF LITERATURE:
A study in 2011by Krzeski A,Galewicz A,Chmielewski R,Kisiel M. Warsaw
MedicalUniversity, Warsaw, Poland showed that while
smoking did not influence preoperative symptoms, smokers had worse postoperative
outcomes in patients undergoing FESS for chronic rhinosinusitis.4
A study in 2011 by Luke Rudmik, Jess C. MaceandTimothy L. Smith, in Canada
showed that Active smoking status does not alter post-operative
improvement in HRQoL after ESS. Although limited by a small sample size,
increasing smoking volume may contribute to worse post-operative endoscopy
scores.9
Another study in 2011 by Proença, M. , et al.in Portugalsuggested that in smokers, although the mucociliary clearance immediately after smoking is similar to non-smokers’, eight hours after smoking it is reduced, and this reduction is closely related to the smoking habits.3
A study in 2010 in Oregon Health and ScienceUniversity by Jess C. Mace,Yvonne L. Michael, Nichole E. Carlson, et alshowed that for most patients, endoscopy scores and disease specific HRQOL significantly improved after endoscopic sinus surgery. Changes in endoscopy scores explain a portion of the improvement in HRQOL. For patients with CRS, improvements in disease specific HRQoL outcomes are complex, multidimensional constructs that cannot be entirely explained by surgical changes measured by endoscopic examination.1
A study in 2009 by Russell D. Briggs MD,Steven T. Wright MD,et al inAustin,
Texasshowed that Smoking is associated with statistically
worse outcomes after ESS based on average SNOT-16 scores. Although no
investigator has proved that the effects of smoking on sinonasal health are reversible,
we counsel smoking patients considering ESS about the desirability of smoking
cessation (for this and many health reasons), and the possibility of a poorer
postsurgery outcome should they continue smoking. 10
In 2009Timothy L. Smith,Sabrina Mendolia-Loffredo,Todd A. Loehrl
,Rodney Sparapani,Purushottam W. Laud,Ann B. Nattinger in their study in Oregon
Health and ScienceUniversityconcluded that smokers and patients with depression
had the leastchange in endoscopy scores.7
The study, as in 2009 authored by Subinoy Das, Adam M. Becker, J. Drew Prosser,
and Stilianos E. Kountakis, Medical College of Georgia using the snot -20 score
stated that continued smokingmay well affect patient’s long term symptomatology
and increase the need for revision surgery for smokers. 14
A study in 1986 by P J Stanley,R Wilson,M A Greenstone,L MacWilliam, andP J Cole showed that the defective clearance seen in chronic cigarette smokers seems unlikely to be due to slowed ciliary beat frequency. It may be due to reduction in number of cilia or to change in the viscoelastic properties of mucus.2
6.3. AIMS & OBJECTIVES OF STUDY
1. To assess the effect of cigarette smoking on the outcome of Functional Endoscopic sinus surgery by a subjective test (SNOT-20 scoring) and an objective nasal endoscopic evaluation (Lund-Kennedy scoring system).
2. To assess the effect of cigarette smoking on the mucociliary clearance using a Saccharin test.
MATERIALS AND METHODS:
7.1.SOURCE OF DATA:
SAMPLING TECHNIQUE : Universal sampling technique
SAMPLE SIZE : All Patients in the age group of 16-60 years presenting to ENT department of A J Institute of Medical Sciences Mangalore who meet the inclusion criteria.
Inclusion criteria:
Study group: individualswho are chronic smokers in the age group of 16-60 who
will be undergoing functional endoscopic sinus surgery
for chronic rhinosinusitis and/or nasal polyps in AJ Institute of Medical sciences.
Chronic rhinosinusitis will be diagnosed by :

Symptoms/signs –

Major symptoms -

Facial pain/pressure
Facial congestion/fullnes
Nasal obstruction/blockage
Nasal discharge/purulence/discoloured posterior drainage
hyposmia/anosmia

6. Purulence on nasal examination
7. Fever (acute rhinosinusitis only)
Minor symptoms –

Headache
Fever(non acute)
Halitosis
Fatigue
Dental pain
Cough
Ear pain/pressure or fullness.

Diagnosis requires two major factors OR one major and two minor
B. Nasal Endoscopy

CT PNS

Control group: Individuals, non-smokers , in the age group of 16-60 who will be undergoing functional endoscopic sinus surgery in AJ institute of medical sciences for chronic rhinosinusitis and/or nasal polyps.
Exclusion criteria: 1. Individuals with chronic rhinosinusitis unfit for surgery or not willing for surgery.
2. Individuals who have been exposed to other occupational irritants that can affect the mucociliary function.
7.2.METHOD OF COLLECTION OF DATA:
STUDY DESIGN : Interventional study.
Chronic smokers (age group 16-60years) with chronic rhinosinusitis who will be undergoing FESS will be recruited in the study group and non-smokers (16-60 years), age and sex matched, with chronic rhinosinusitis who will be undergoing FESS will be recruited as control group in the study after obtaining informed consent from both the groups .After explaining the procedures and obtaining informed consent from patient/parent /guardian ,a preoperative subjective analysis using a Saccharin test , the snot-20 scoring system and an endoscopic assessment using the Lund- Kennedy scoring system is done. Following FESS a saccharin test, a subjective analysis of the outcome of the surgery will be obtained using the snot-20 scoring system followed by an objective endoscopic assessment using the Lund-Kennedy method in each individual at 1 and 3 months.
STATISTICAL ANALYSIS : Paired t- test will be used to test the significance of the difference before and after treatment. Student t-test will be used to test for the significance of the difference between two independent groups.
7.3 Does the study require any investigation or interventions to be conducted on patients or other human or animals? If so, please describe briefly.
Yes, mentioned in 7.2
7.4 Has the ethical clearance obtained from your institution?
YES
8 /

LIST OF REFERENCES:

1. Jess C Mace, Yvonne L.Michael, Nichole E Carlson, Jamie R Litvack, Timothy L Smith. Correlations between Endoscopy score and Quality-of-Life changes after sinus surgery .2010 April: 340-346.

2. P J Stanley, R Wilson, M A Greenstone, L MacWilliam , P J Cole. Effect of cigarette smoking on nasal mucociliary clearance and ciliary beat frequency . 1986 July ;41(7): 519-523.
3. Proenca M , Fagundes Xavier R , Ramos D, Cavalheri V, Pitta F , Cipulo R. Immediate and short term effect of smoking on nasal mucociliary clearance in smokers. 2011;17:172-6.
4. Krzeski A, Galewicz A, Chmielewski R, Kisiel M. Influence of cigarette smoking on endoscopic sinus surgery long term outcomes. 2011 December;49(5):577-82.
5. Sheri J Polley. Is Endoscopic sinus surgery contraindicated for smokers. 2007 August.
6. Peter H Hwang , Jayakar V Nayak , Jane Y Wang . Endoscopic Sinus Surgery : A patient’s guide.
7. .Smith TL, Mendolia-Loffredo S, Loehrl TA, et al. Predictive factors and outcomes in endoscopic sinus surgery for chronic rhinosinusitis.Laryngoscope.2005;115:2199–205.
8. Hassan H Ramadan , Raymond A Hinerman . Smoke exposure and outcome of endoscopic sinus surgery in children. 2002 December :546-548.
9. Luke Rudmik, Jess C Mace, Timothy L Smith . Smoking and Endoscopic Sinus Surgery : Does smoking volume contribute to clinical outcome. 2011 May-June;1920 :145-152.
10.Russel D Briggs , Steven T Wright , Stephanie Cordes , Karen H Calhoun. Smoking in chronic rhinosinusitis : A predictor of poor Long-Term Outcome After Endoscopic Sinus Surgery. Laryngoscope. 2004 January ;114: 126-128.
11.Smith TL, Litvack JR, Hwang PH, et al. Determinants of outcomes of sinus surgery: a multi-institutional prospective cohort study.Otolaryngol Head Neck Surg.2010;142:55–63.
12.Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group.Ann Otol Rhinol Laryngol Suppl.1995;167:17–21.
13.Lund VJ, Mackay IS. Staging in rhinosinusitus.Rhinology.1993;31:183–4.
14. Subinoy Das, Sunny S, Stilianos E. Kountakis et al . Effects of smoking on quality of life following sinus surgery:4 year follow up. 2009;119:2284-2287.
9 / SIGNATURE OF CANDIDATE:
10 / REMARKS OF THE GUIDE:
11 / NAME AND DESIGNATION OF:
11.1. GUIDE / DR. KAVITHA ASHOK KUMAR PROFESSOR
DEPARTMENT OF ENT
A.J.INSTITUTE OF MEDICAL SCIENCES
KUNTIKANA, MANGALORE - 575004
11.2. SIGNATURE
11.5. HEAD OF THE OF THE DEPARTMENT: / DR.DEVAN P.P,
PROFESSOR AND HOD ENT,
A.J.INSTITUTE OF MEDICAL SCIENCES,KUNTIKANA,MANGALORE-575004
11.6. SIGNATURE:
12 / 12.1.REMARKS OF THE CHAIRMAN AND PRINCIPAL:
12.2.SIGNATURE OF THE PRINCIPAL:

A. J. INSTITUTE OF MEDICAL SCIENCES, MANGALORE

Title : “A COMPARATIVE STUDY ON THE OUTCOME OF FUNCTIONAL ENDOSCOPIC SINUS SURGERY BETWEEN SMOKERS AND NON SMOKERS WITH CHRONIC RHINOSINUSITIS AND/OR NASAL POLYPS”

PROFORMA FOR DATA COLLECTION

A.Personal Details

1.Name :

2.Age:

3.Sex:

4. Occupation :

4. Father’s/Mother’s name :

5.I.P. No.:

9.Date :

10.Address:

B.HISTORY AND EXAMINATION

Chief complaints

Present history

Past history

Personal history

Family history

Social history

Obstetrics history

Medication history

General physical examination

EXAMINATION OF NOSE:

External Examination of Nose-

Cold spatula test

Anterior Rhinoscopy-
Colour of Mucosa
Nasal septum
Nasal cavity

a. Discharge b. Crusts c. Polyp d. Any other mass e. Bleeding

f. Maggots (if any)

Posterior Rhinoscopy –
Examination of Sinuses –

a)Inspection

b)Palpation

EXAMINATION OF EAR:

EXAMINATION OF ORAL CAVITY AND THROAT :

SYSTEMIC EXAMINATION :

C. SACCHARIN TEST :

Time of placing saccharin in nose / Time at which patient feels the sweetness in throat
Saccharin transit time (STT) :

D. Questionnaire for SNOT-20 SCORING:

1.Considering how severe the problem is when you
experience it and how frequently it happens,
please rate each item below on how "bad" it is by
circling the number that corresponds with how
you feel using this scale: → / No problem / Very mild problem / Mild or slight problem / Moderate problem / Severe problem / Problem as bad as it can be / 5 MOST IMPORTANT ITEMS
1. Need to blow nose / 0 / 1 / 2 / 3 / 4 / 5
2. Sneezing / 0 / 1 / 2 / 3 / 4 / 5
3. Runny nose / 0 / 1 / 2 / 3 / 4 / 5
4. Cough / 0 / 1 / 2 / 3 / 4 / 5
5. Post-nasal discharge / 0 / 1 / 2 / 3 / 4 / 5
6. Thick nasal discharge / 0 / 1 / 2 / 3 / 4 / 5
7. Ear fullness / 0 / 1 / 2 / 3 / 4 / 5
8. Dizziness / 0 / 1 / 2 / 3 / 4 / 5
9. Ear pain / 0 / 1 / 2 / 3 / 4 / 5
10. Facial pain/pressure / 0 / 1 / 2 / 3 / 4 / 5
11. Difficulty falling asleep / 0 / 1 / 2 / 3 / 4 / 5
12. Wake up at night / 0 / 1 / 2 / 3 / 4 / 5
13. Lack of a good night’s sleep / 0 / 1 / 2 / 3 / 4 / 5
14. Wake up tired / 0 / 1 / 2 / 3 / 4 / 5
15. Fatigue / 0 / 1 / 2 / 3 / 4 / 5
16. Reduced productivity / 0 / 1 / 2 / 3 / 4 / 5
17. Reduced concentration / 0 / 1 / 2 / 3 / 4 / 5
18. Frustrated/restless/irritable / 0 / 1 / 2 / 3 / 4 / 5
19. Sad / 0 / 1 / 2 / 3 / 4 / 5
20. Embarrassed / 0 / 1 / 2 / 3 / 4 / 5

E. NASAL ENDOSCOPIC ASSESSMENTBY LUND-KENNEDY METHOD:

PREOPERATIVE / POSTOPERATIVE
FEATURES / RIGHT NASAL CAVITY / LEFT NASAL CAVITY / RIGHT NASAL
CAVITY / LEFT NASAL
CAVITY
1 month / 3 month / 1 month / 3 month
POLYP (0,1,2)
EDEMA (0,1,2)
DISCHARGE (0,1,2)
TOTAL

Notes :

Polyp : 0- absent , 1-restricted to middle meatus, 2-extending into nasal cavity

Edema of mucosa : 0- absent , mild/moderate edema, 2- polypoid degeneration

Discharge: 0-absent , 1- hyaline, 2 – thickened and/or mucopurulent

F. INVESTIGATIONS :

Blood investigations

a. CBC

b.Serology:

c.Bleeding time and Clotting time:

d.Blood groupig and Rh typing :

e.B.Urea: f . S.Creatinine : g. RBS:

h. CT PNS :

G. DIAGNOSIS:

H . DATE AND DETAILS OF SURGERY DONE :

I. Questionnaire for SNOT-20 SCORING postoperatively at 1 and 3 months:

J. POSTOPERATIVE SACCHARIN TEST :

Time of placing saccharin in nose / Time at which patient feels the sweetness in throat
Saccharin transit time (STT) :

TIMELINE

TITLE : A COMPARATIVE STUDY ON THE OUTCOME OF FUNCTIONAL ENDOSCOPIC SINUS SURGERY BETWEEN SMOKERS AND NON SMOKERS WITH CHRONIC RHINOSINUSITIS AND/OR NASAL POLYPS

Phase / Time Period / Activity
1. / August - 2013 to
October – 2013 / 1. Identification of the problem
2. Review of literature
3. Preparing of proforma
4. Pilot Study
5. Preparation and submission of synopsis
2. / November 2013ToNovember 2014 / Collection of Data
3. / November 2014ToNovember 2015 / Analysis and Discussion of collected data
Submission
Written Informed Consent Form

A J INSTITUTE OF MEDICAL SCIENCES,

KUNTIKANA, MANGALORE.

Informed consent form for the volunteers at “A J Institute of Medical Sciences, Kuntikana, Mangalore”, who will be participating in the research project (MS dissertation) entitled : “A COMPARATIVE STUDY ON THE OUTCOME OF FUNCTIONAL ENDOSCOPIC SINUS SURGERY BETWEEN SMOKERS AND NON SMOKERS WITH CHRONIC RHINOSINUSITIS AND/OR NASAL POLYPS”

Name of Principal Investigator / Dr. Shruti Manjunath,
Postgraduate student
Name of Organization / Department of ENT,
A J Institute of Medical Sciences, Kuntikana, Mangalore

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. Shruti Manjunath, postgraduate student in the Department of ENT, A J Institute of Medical Sciences, Kuntikana, Mangalore, am working on my MS dissertation titled “A COMPARATIVE STUDY ON THE OUTCOME OF FUNCTIONAL ENDOSCOPIC SINUS SURGERY IN SMOKERS AND NON SMOKERS WITH CHRONIC RHINOSINUSITIS AND/OR NASAL POLYPS”.

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

Chronic Rhinosinusitis is characterized by the inflammation of the mucosa of the nose and paranasal sinuses of atleast 12 consecutive weeks’ duration.

The two main aetiologies include 1. Any anatomical obstruction to the sinus ostia and 2. defective mucocilliary clearance due to which the sinuses are unable to

drain adequately. As a result, normal nasal secretions become trapped in the sinuses