RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web...

32
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION TITLE OF THE TOPIC “CLINICAL STUDY AND MANAGEMENT OF SINONASAL POLYPOSIS” by DR. S. NAZIA AMBREEN P.G M.S ENT (OTORHINOLARYNGOLOGY), AL-AMEEN MEDICAL COLLEGE, 1

Transcript of RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web...

Page 1: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

SYNOPSIS FOR REGISTRATION OF

SUBJECT FOR DISSERTATION

TITLE OF THE TOPIC

“CLINICAL STUDY AND MANAGEMENT OF SINONASAL POLYPOSIS”

by

DR. S. NAZIA AMBREEN

P.G M.S ENT (OTORHINOLARYNGOLOGY),

AL-AMEEN MEDICAL COLLEGE,

BIJAPUR

1

Page 2: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1Name of the candidate and Address (in block

letters)

DR. S. NAZIA AMBREENPRESENT - c/o H.A.HUSSAIN NAIK, OPP. J.M. MARRIAGE HALL, SHASRTINAGAR, BIJAPUR - 586102PERMANENT – NO. 137, SEPPINGS ROAD, BANGALORE - 560001

2 Name of the Institution AL-AMEEN MEDICAL COLLEGE, BIJAPUR

3 Course of study and Subject M.S. ENT (OTORHINOLARYNGOLOGY)

4 Date of admission to course 4th JUNE-2012

5 Title of the topic “CLINICAL STUDY AND MANAGEMENT OF SINONASAL POLYPOSIS”

6 Brief resume of the intended work

6.1 Need for the study Vide Annexure – I

6.2 Review of literature Vide Annexure – II

6.3 Objectives of the Study Vide Annexure – III

7 Material and Methods

7.1 Source of Data Vide Annexure – IV

7.2 Method of collection of data (including

sampling procedure, if any)Vide Annexure – V

7.3 Does the Study require any investigations

or interventions to be conducted on patients or

other humans or animals? If so, please

describe briefly.

Vide Annexure – VI

7.4 Has ethical Clearance been obtained from

your institution in case of 7.3

7.5 Sample informed consent form

Yes (Certificate has been enclosed herewith)

8 List of References Vide Annexure – VII

9 Signature of the Candidate

2

Page 3: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

10 Remarks of the Guide This study will help in the better understanding of the clinical presentation, the different modalities of investigation and the recurrence rate after medical and surgical management in sinonasal polyposis.

11Name and Designation of ( in block letters )

11.1 Guide

DR. M. V. WATWEDLO, DNB (ENT)PROFESSORDEPARTMENT OF ENTAL-AMEEN MEDICAL COLLEGE, BIJAPUR

11.2 Signature

11.5 Head of the Department

DR. S. M. RASHINKARDLO, MS (ENT)PROFESSOR AND H.O.DDEPARTMENT OF ENTAL-AMEEN MEDICAL COLLEGE, BIJAPUR

11.6 Signature

12.1 Remarks of the Chairman and Dean

12.2 Signature

3

Page 4: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

ANNEXURE – I

BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY

The word polyp comes from Greek and subsiquently Latinized word “poly-pous”, which means

many footed.

Nasal polyposis is known to man for almost 5000 years. Many hypothesis concerning its

pathogenesis have been proposed since then. But till now there is no clear evidence for any single cause.

Nasal polyps are defined as pearly white, painless, prolapsed pendunculated parts of nasal mucosa.

They are unique in their position and their compostion.

On examination, polyps appear as “pale bags” which arise most commonly from middle meatus and

are relatively in sensitive when probed.

Tonnes have been written over these benign growths for centuries. From ancient India when polyps

were recognised as an entitiy through the era of Hippocrates.

Nasal polyps appear to be a uniform inflammatory reaction of nasal mucosa, specially in the middle

meatus and the anterior ethmoidal cells.

They commonly occur in systemic disease such as immotile cilia syndrome, cystic fibrosis, aspirin

intolerance and often coincide with intrinsic asthma.

Patient with Nasal polyposis suffers from nasal obstuction, recurrent sinusitis, hyposmia, headache

and post nasal drip.

If nasal polyps occlude the sinuses and lead to symptomatic sinusitis, pulmonary parameters often

worsen and subsequently improve after successful treatment of sinus disease.

4

Page 5: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

Therapy of nasal polyps is one of the major challenge for both conversative and surgical spproaches

including endoscopic sinus surgery.

Nasal polyps have tendency to recur as long as underlying disease cannot be eradicated.

The understanding of pathophysiology and the management of nasal polyposis has long been a

vexing problem for the treating clinician. The past two decades have seen a confluence of advances in

optics, radiographic imaging and surgical technique.

The emergence of nasal endoscopes and computed tomography have revolutionized our

understanding and pathophysiology of nasal polyposis and have radically changed the concept of its

management.

5

Page 6: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

ANNEXURE – II

6.2 REVIEW OF LITERATURE

Nasal polyps were first recognised in India, and by 1000 BC curettes had been devised to remove them.1

Hippocrates (460-370 BC) recognized them, as well as devised a method of removing them using a piece

of string which was passed through nose into nasopharynx. A piece of sponge was attached to the post nasal

end and the sponge was pulled through the nose removing the polyps before it.2

Zuckerkandl (1892) understood that they were an inflammatory condition.3

Killian et al (1906), gave 1st detailed description of this condition and were considered the origin to be

antrum of highmore.4

Schramm and Effron (1980) reviewed 120 paediatric cases with nasal polyposis and 33% of these were

antrochoanal polyps. They also found that 29% of children presenting with nasal polyposis had cystic

fibrosis.5

Berg O et al (1988) did a study on the origin of the choanal polyp. The found in 15 patients that an antral

cyst or a cystic rudiment, was usually attached to the inferolateral aspect of the sinus wall. As a part of the

choanal polyp, the antral cyst exhibited a macroarchitecture and microarchitecture identical to the structure

of the common intramural cyst of the maxillary sinus was studied in nine patients. It was concluded that the

choanal polyp develops from the expanding intramural cyst protruding through the maxillary ostium and

into the nasal cavity. 6

Chamyal PC (1992) did a study of 15 years durarion on nasal polyopsis in children and found that the

incidence of nasal polyposis in children was less than 1% of all nasal cases attending the ENT centres.

However, the incidence rose sharply and ranged upto 6 to 9% in cases associated with mucovisidosis.7

Cook et al (1993) reviewed 33 patients with antrochoanal polyps and found 70% were between 30-70 years

age group and 15% were below 20 years age group.They also found that 24% of patients with ethmoidal

polyps had the aspirin sensitivity, asthma triad. Review of 33 cases, noted statistically significant

association with allergic status (23 out of 33). Strong association between ethmoidal polyp, aspirin

hypersensitivity and asthma (8 out of 33) was found.8

Holmberg K el al (1997) compared the effect of fluticasone propionate to that of beclomethasone

dipropionate as nasal spray in nasal polyposis and found that fluticasone has faster action unless tolerated at

6

Page 7: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

least as well as beclomethasone dipropionate at the same dose. Fluticasone propionate is reported to be

highly effected when used topically for seasonal and perennial allergic and non allergic rhinitis. 200 micro

gram bid and beclomethasone dipropionate nasal spray 200 micro gram bid are effective in treating the

symptoms of nasal polyp with some evidence that fluticasone propionate has faster onset of action.9

Larsen and Tos (1997) conducted a long term follow up study of nasal polyp patients after simple

polypectomy and concluded that patients with asthma have more polypectomies that those without. Patients

with a history of aspirin hypersensitivity had the highest number of polypectomies. Previous troublesome

sinusitis and allergy seemed out to exert major influence on number of polypectomies needed.10

Triglia et al (1997) studied sinonasal in children and found that 80 percent of patients with ethmoidal

polyposis are associated with asthma, and 22 percent of patients with polyposis were associated with cystic

fibrosis.11

Yamada T et al (2000) concluded that macrolide (azithromycin) treatment resulted in decrease in the size

of nasal polyps and IL-08 levels in nasal lavage.12

Blomqvist E H et al (2000), sought to compare the effect of medical treatment versus combined surgical

and medical treatment on olfaction, and other nasal symptoms in nasal polyposis. The sense of smell was

improved by the combination of local and oral steroids and surgery had no additional effect. Symptoms

improved significantly with medical treatment alone but surgery had additional beneficial effect on nasal

obstruction and secretion.13

Zheng C et al (2000) studied effect of intra nasal treatment with capsaicin on the recurrence of polyps after

polypectomy and ethmoidectomy in 29 patients. They kept the cotton pellet soaked with capsaicin into the

middle meatus of both nostrils for 20 min once a week for 5 weeks and found that there is marked reduction

in their nasal obstruction and polyp dimensions and could be alternative treatment to expensive

corticosteroids in developing countries.14

Badia L et al (2001) laid down the objectives of medical management to eliminate or reduce the size of

polyp, reestablish nasal airway and nasal breathing, improve or restore the sense of smell and prevent the

occurrence of nasal polyps. The mechanism of action of corticosteroid may be multifactorial on various

aspects of inflammatory reaction. When polyps are large (grade 3) topical medication is difficult to instill in

a blocked nose and surgery or short term corticosteroid therapy may be required. The typical corticosteroid

ate of use in the primary treatment of nasal polyps when they are of small or medium size (grade 1 and

grade 2) and in the maintenance of any therapeutic improvement. The efficacy of topical corticosteroids

such as betamethasone, beclomethasone dipropionate, fluticasone propionate and budesonide nasal spray in

reducing the polyp size and rhinitis symptoms had been demonstrated.15

7

Page 8: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

Kaushal A el at (2004) studied 20 cases of Antrochoanal Polyps which were subjected to EESS for

studying the site of origin and to validate its efficacy. They found the age at the time of presentation to

range from 7-35 years. The mean duration of symptoms was 3 years. The main presenting symptom was

unilateral nasal obstruction in 100% of cases. Antroscopy revealed the antral part to be cytic in 100% of the

cases. The site of origin of the polyp could be ascertained in only 12 out of 20 cases; in 7 of them it arose

from the inferolateral wall of maxillary sinus, in 2 from the infrromedial wall und in 2 it appeared to arise

from the supromedial wall while in 1 from margin of the ostium. Endoscopic Sinus Surgery was found the

best modality of treating Antrochoanal Polyps they reported a success rate of 95% in their series. 16

Nair S et al (2011) did a comparative study on presentation and treatment outcome after endoscopic sinus

surgery in patients of chronic rhinosinusitis and nasal polyposis. They found that the patients with chronic

rhinosinusitis and nasal polyp have varied severity of symptoms, and that the nasal polyp group having

higher nasalsymptoms and increased severity as compared to chronic rhinosinusitis group. Post endoscopic

sinus surgery they found that there is a reduction in both objective and subjective symptom scores during

1 year follow up in the nasal polyp group. 17

Lathi A et al (2011) did a study examining the clinico-pathological profile of sinonasal masses  in 112

patients for a period of 2 years. Non-neoplastic nasal polyploid masses were found 80 (71.4%) subjects. The

most common site of origin of polyploid masses was the middle meatus (54.4%) followed by the lateral wall

of the nasal cavity (16.1%) and superior meatus (10.7%). Allergic (62.5%) and inflammatory

(25%) polyps were the most common non-neoplastic masses found. 18

8

Page 9: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

ANNEXURE – III

6.3 OBJECTIVES OF THE STUDY

1. To study the clinical presentation of nasal polyposis in different age and sex distributions.

2. To study the different modalities of investigation and to compare the effect of medical and surgical

management of nasal polyposis.

3. To study the recurrence rate in nasal polyposis after medical and surgical management.

9

Page 10: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

ANNEXURE – IV

MATERIAL AND METHODS

7.1 SOURCE OF DATA

Clinical material for present study comprises patients attending the out patient department of

otorhinolaryngology at Al-Ameen Medical College Hospital, Bijapur between December 2012 to December

2014 with antrochoanal polyps and ethmoidal polyposis.

INCLUSION CRITERIA

1. Patient presenting with unilateral polypoidal nasal mass suggestive of Antrochoanal polyp

2. Patient presenting with bilateral polypoidal nasal mass suggestive of Ethmoidal polyposis

3. Patients presenting with recurrent polyps

EXCLUSION CRITERIA

1. Neoplastic nasal masses

2. Granulomatous nasal masses

3. Nasal polyps in pregnant patients

4. Patients with other ENT diseases

5. Pateints with fungal sinusitis

10

Page 11: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

ANNEXURE – V

7.2 METHOD OF COLLECTION OF DATA

EQUIPMENTS REQUIRED1. Bull's eye lamp2. Head mirror3. Tongue depressor4. Nasal specula5. Laryngeal mirrors of various sizes6. Posterior Rhinoscopy mirrors of various sizes7. Ear specula8. Siegle's speculum9. Tuning forks of 256, 512, 1024 Hz10. Jobson Horne probe11. Otoscope12. Gloves13. Suction apparatus14. Rigid Hopkin's rod endoscopes 00 and 300

15. Cold Light Source16. Fibre Optic Cable17. Sickle Knife18. Wildes upturned forceps19. Blakesly forceps20. Kerrison bone punches21. Ostrum's forceps22. Nasal scissors23. Struycken's nasal cutting forceps24. Scoops and suctions

METHOD OF EXAMINATIONThe standard procedure of examination of ear, nose, throat, oral cavity, face and neck shall be carried out on

each patient in the out patient department of the hospital.

The patient be made comfortable and a detailed history of his complaints will be taken under the various

headings mentioned in the proforma.

Thorough clinical examination of ear, nose, throat, oral cavity, face and neck.

First examination is done by anterior and posterior rhinoscopy. Nasal endoscopy in carrired out in each

patient with 00 and 300 Hopkin's rod endoscope. Nasal decongestant spray is used wherever necessary and

4% xylocaine for topical anaesthesia. Grading of nasal polyps is done regarding clinical symptoms and

nasal endoscopy (as per guidelines of Johansson et al).19

11

Page 12: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

PROFORMA

TOPIC: CLINICAL STUDY AND MANAGEMENT OF SINONASAL POLYPOSIS

GUIDE: DR. M. V. WATWE

D.LO, DNB (ENT)

PROFESSOR

DEPARTMENT OF ENT

CANDIDATE: DR. S. NAZIA AMBREEN

CASE RECORD

S. No: Opd/Ipd No: Date:

Name: Age/Sex:

S/o;D/o;W/o: Address:

Occupation: Religion:

CHIEF COMPLAINTS DURATION

1. Nasal blockage

Unilateral/Bilateral

2. Running Nose

3. Sneezing

4. Anosmia

5. Postnasal drip

6. Pain

7. Epistaxis

8. Hyponasal voice

9. Mass protruding from nostrils

12

Page 13: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

10. Headache

PAST HISTORY

Tuberculosis Asthma Seizures

Diabetes Mellitus Hypertension h/o Any Nasal Surgery

PERSONAL HISTORY

Diet: Appetite: Sleep:

Marital Status: Bladder: Bowels:

Addictions

FAMILY HISTORY

Tuberculosis Asthma Malignancy

Similar complaints in the family

GENERAL EXAMINATION

General Condition Built Nutrition

Pallor / Cyanosis / Clubbing / Icterus / Edema / Lymphadenopathy

Pulse: B.P.

Respiration: Temperature:

SYSTEMIC EXAMINATION

CNS CVS

RS P/A

13

Page 14: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

LOCAL EXAMINATIONNOSE: RIGHT LEFT

External Appearance

Columella

Vestibule

Anterior Rhinoscopy (nasal Cavity shows)

◦ Mucosa◦ Floor of Nose◦ Septum◦ Nasal Passage◦ Lateral Wall

Probe Test

Posterior Rhinoscopy

Paranasal Sinus Tenderness

◦ Maxillary◦ Ethmoidal◦ Frontal

Smell Sensation

Nasal Patency Tests

◦ Cold Spatula Test◦ Cotton Wool Test◦ Cottle's Test

Examination of Ear: Routine

Examination of Oral Cavity, Oropharynx: Routine

Examination of Neck: Routine

Neurological examination

Ophthalmological examination

Dental examination

Investigations

Diagnostic Nasal Endoscopy

◦ 1st Pass (Examination of nasopharynx and inferior meatus)

▪ Nasal Cavity (mucosa, septum)▪ Eustachian tube openings▪ Walls of nasopharynx▪ Upper surface of soft palate and uvula▪ Margins of choanae ▪ Posterior ends of turbinates▪ Nasolacrimal duct opening▪ Hasner's valve

14

Page 15: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

◦ 2nd Pass

▪ Sphenoethmoidal recess▪ Superior Turbinate and Meatus

◦ 3rd Pass (Examination of Middle Meatus in detail)

▪ Uncinate process▪ Bulla Ethmoidalis▪ Hiatus Semilunaris▪ Frontal Recess

Radiological Study

◦ Plain X-rays

▪ Water's view

▪ Caldwell's view

◦ CT scan PNS

◦ MRI

◦ Chest X-ray

Histopathological examination

Treatment

◦ Medical

▪ Topical Steroids

▪ Oral Steroids

▪ Antibiotics

▪ Decongestants

▪ Antihistamines

▪ Leukotrines Antagonist

◦ Surgical

▪ Polypectomy

▪ Polypectomy + FESS

Post Operative Medical Treatment

Follow up

◦ 1st

◦ 2nd

15

Page 16: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

ANNEXURE – VI

7.3 INVESTIGATIONS REQUIRED FOR THE STUDY

Complete Haemogram Hb% TLC

DLC P L M B E

Absolute Eosinophil Count (AEC)

Platelet Count

ESR

Random Blood Sugar

Blood Urea

Serum Creatinine

Serum Amylase

Urine

◦ Routine

◦ Microscopy

Diagnostic Nasal Endoscopy

◦ 1st Pass

◦ 2nd Pass

◦ 3rd Pass

Nasal smear for eosinophilia

Histopathological Examination

Radiological Study

◦ Plain X-rays

▪ Water's view

▪ Caldwell's view

◦ CT scan PNS

◦ MRI

◦ Chest X-ray

Echocardiography

16

Page 17: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

MODALITIES OF TREATMENT

The treatment of nasal polyp will differ according to their type

Medical

In ethmoidal polyposis, initially medical therapy can be in the form of topical nasal steroids for mild

disease. However, after a trial of 1 to 3 months of topical treatment without any response, such as in case of

extensive mucosal polyposis, oral steroids are indicated. Topical steroid should be continued, concurrently

antibiotic, decongestant, leukotrine Antagonist and antihistamine treatment can also be added. At the end of

the treatment response should be reassessed by endoscopy and CT scan.

Surgical

Indications:

1) Antrochoanal polyp

2) Failure of medical therapy in ethmoidal polyposis

3) Patient who is not a candidate for oral steroids

4) Persistance of infection or complication of sinus disease such as mucocoele

Techniques:

1) Trans-nasal polypectomy under direct vision

2) FESS (Functional Endoscopic Sinus Surgery)

3) Caldwell Luc Operation

17

Page 18: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

7.4 ETHICAL COMMITTEE

The following study entitled “Clinical Study And Management Of Sinonasal Polyposis” by Dr. S. Nazia

Ambreen, P.G. M.S. ENT (Otorhinolaryngology), 2012 batch has been cleared from the ethical committee

of this institution for the purpose of dissertation work.

Date: Chairman

Ethical Committee

Al Ameen Medical College

Bijapur

18

Page 19: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

7.5 SAMPLE INFORMED CONSENT FORMRESEARCH INFORMED CONSENT FORM

TITLE OF THE STUDY: “CLINICAL STUDY AND MANAGEMENT OF SINONASAL

POLYPOSIS”

PRINCIPAL INVESTIGATOR: Dr. S. Nazia Ambreen

PG GUIDE: Dr. M.V. Watwe, Professor (ENT)

PURPOSE OF STUDY

This study is for better understanding of the clinical presentation, the different modalities of investigation and the recurrence rate after medical and surgical management in sinonasal polyposis.

RISKS AND DISCOMFORTS

I understand that I may experience some pain or discomfort during the examination or during the treatment. This is mainly the result of my condition and the procedure of the study is not expected to exaggerate these feelings which are associated with the usual course of treatment. The risk and possible complications surgically and anaesthetically have been explained to me.

BENEFITS

The benefits of technique have been conveyed to us.

ALTERNATIVES

The various alternative modes of treatment available to me in my disease with merits and demerits have been explained to me.

CONFIDENTIALITY

I understand medical information produced by this study will become part of the hospital record and will be subject to the confidentiality and privacy regulations of the hospital. If the data are used for publication in the medical literature for teaching purposes, no names will be used, and other identifiers, such as photographs and audio or videotapes, will be used only with my special written permission. I understand, I may see the photographs and videotapes and hear the audio tapes before giving this permission. For this purpose every effort will be made by publishing person to contact me in the address furnished by me through postal communication. If no response is received within a reasonable time, all the identities will be removed from the photographs and case report before being submitted for publication.

REQUEST FOR MORE INFORMATION

I understand that, I may be asked more questions about the study at any time. Researcher is available to answer my questions or concern in this research period. I understand that I will be informed of any significant new findings discovered during the course of this study, which might influence my continued participation.

19

Page 20: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

REFUSAL OR WITHDRAWL OF PARTICIPATION

I understand that my participation is voluntary and I may refuse to participate or discontinue participation in the study at any time without prejudice to my present or future care at this hospital. I also understand that the researcher may terminate my participation in the study at any time after I have been explained the reasons for doing so.

INJURY STATEMENT

I understand that in the unlikely event of injury to me resulting directly from my participation in this study, if such injury were reported promptly, then medical treatment would be available to me, but no further compensation would be provided. I understand that by agreement to participate in the study I am not waiving any of my legal rights.

I have explained to _________________________________________

(Patient’s Name)

The purpose of research, the procedures required and the possible risk and benefits to the best of my ability.

-----------------------------------

Investigator Date:

I have been explained clearly about the reason for doing this study, reason for selecting me as a subject in the study. I have also been explained about the risks, benefits and confidentiality of the study. Alternative procedures that might be used in the treatment of my disease also explained to me. I am willing to attend any follow up requested to me at a future date. Freedom is given to me for the participation in the study or discontinue participation at any time without prejudice. All the above explained in detail to me clearly in my own language. I am giving consent voluntarily for inclusion of myself in the study as a subject.

-----------------------------------

Participant’s parent

Date:

-----------------------------------

Witness to signature

20

Page 21: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

ANNEXURE – VII

LIST OF REFERENCES

1. Vancil, M. E., A historical survey of treatments for nasal polyposis. The Laryngoscope 1969;

79: 435–445.

2. Drake-Lee AB. Nasal polyps. In: Kerr AG, Mackay AS, Bull TR, editors. Scott-Brown’s

Otolaryngology. 6. Vol. 4. Rhinology, Oxford: Butterworth-Heinneman; 1997. 4/10/1-16.

3. Zuckerkandl E. Normale und pathologische Anatomie der Nasenholme. Vienna 1892 .

4. Killian G. The origin of choanal polypi. Lancet 1906;2:81-2

5. V. L. Schramm, Jr, M. Z. Effron. Nasal polyps in children. Laryngoscope. 1980 September; 90(9):

1488–1495.

6. Berg O, Carenfelt C, Silfverswärd C, Sobin A. Origin of the Choanal Polyp. Arch Otolaryngol Head

Neck Surg.1988;114(11):1270-1271. 

7. Chamyal PC. Nasal polyposis in children. Indian J Pediatr. 1992 May-Jun;59(3):357-9.

8. Cook PR, Davis WE, McDonald R, McKinsey JP. Antrochoanal polyposis: A review of 33 cases.

Ear Nose Throat J 1993;72:401-12

9. Holmberg K, Juliusson S, Balder B, Smith DL, Richards DH, Karlsson G. Fluticasone propionate

aqueous nasal spray in the treatment of nasal polyposis. Ann Allergy Asthma

Immunol. 1997;78:270–276.

10. Larsen K, Tos M. A long-term follow-up study of nasal polyp patients after simple polypectomies.

Eur Arch Otorhinolaryngol. 1997;254 Suppl 1:S85-8.

11. Triglia JM, Nicollas R. Nasal and sinus polyposis in children. Laryngoscope. 1997 Jul;107(7):963-6.

21

Page 22: RAJIVA GANDHI UNIVERSITY OF HEALTH …rguhs.ac.in/cdc/onlinecdc/uploads/01_M014_35306.doc · Web viewRAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA SYNOPSIS FOR REGISTRATION

12. Yamada T, Fujieda S, Mori S, Yamamoto H, Saito H. Macrolide treatment decreased the size of

nasal polyps and IL-8 levels in nasal lavage. Am J Rhinol. 2000 May-Jun;14(3):143-8.

13. Blomqvist EH, Lundblad L, Anggård A, Haraldsson PO, Stjärne P. A randomized controlled study

evaluating medical treatment versus surgical treatment in addition to medical treatment of nasal

polyposis. J Allergy Clin Immunol. 2001 Feb;107(2):224-8.

14. Zheng C, Wang Z, Lacroix JS. Effect of intranasal treatment with capsaicin on the recurrence of

polyps after polypectomy and ethmoidectomy. Acta Otolaryngol. 2000 Jan;120(1):62-6.

15. Badia L, Lund V. Topical corticosteroids in nasal polyposis. Drugs. 2001;61(5):573-8.

16. Anuj Kaushal, Lakshmi Vaid, P. P. Singh. Antrochoanal polyp — Validating its origin and

management by endonasal endoscopic sinus surgery (eess). Indian J Otolaryngol 56(4):273-

279 (2004).

17. Nair S, Dutta A, Rajagopalan R, Nambiar S. Endoscopic sinus surgery in chronic rhinosinusitis

and nasal polyposis: a comparative study. Indian J Otolaryngol Head Neck Surg. 2011 Jan;63(1):50-

5. Epub 2011 Jan 18.

18. Lathi A, Syed MM, Kalakoti P, Qutub D, Kishve SP. Clinico-pathological profile of sinonasal

masses: a study from a tertiary care hospital of India. Acta Otorhinolaryngol Ital. 2011

Dec;31(6):372-7.

19. Johansson L, Akerlund A, Holmberg K, Melen I, Stierna P, Bende M. Evaluation of methods for

endoscopic staging of nasal polyposis. Acta Oto-Laryngologica. 2000;120(1):72–76.

22