Most Common Benign Intranasal Lesion Biology Essay

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Nasal polyposis is the most common benign intranasal lesion.The managementremain achallenge to the treating physician. The treatment modalitiesinclude both medical and surgery. Surgical treatment is a blind procedure,comprises of polypectomy and ethmoidectomy which have high recurrence rate and have significant complications. All these shortcomings are overcome by endoscopic sinus surgery( ESS), which is nowbecomingthe choice ofsurgical treatment for nasal polyposis . Hirschmann in 1991 did the first attempt at nasal and sinus endoscopyusing modified cystoscope. Since then,many advances have been made and endoscopic sinus surgery is becoming a popular approach.

At present, the Department of Otorhinolaryngology- Head and Neck Surgery of Southern PhilippinesMedical Center geared towards such advances insinus surgery through endoscopy since 2003. However, there has been no local study yet ever done as to evaluate and assess the outcome of endoscopic sinus surgery in this institution.

General quality of life (QOL) measurement tolls have been used to evaluate the impact of a variety of acute and chronic illnesses but may be limited when used to measure the disease-specific impact on patients perception of disability or the outcome from treatment. Therefore based on the form outlined by Kennedy et al in 1989 which is regarded asdisease-specific, self reported outcome measurement tool, we will evaluate the symptom outcome of patients with nasal polyposisthat will undergo ESS in two year period in Southern Philippines Medical Center.

Relationships of research objectives, data subtrates, operationally-defined variables and data analyses

Objectives

Data substrates

Operationally-defined variables

Analyses

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To describe the demographic profile of the patients who will undergo endoscopic sinus surgery

Questionnaire

-Mean age

-Proportion of the distribution of sex and martial status

Descriptive statistics using means and proportions

To describe the clinical profile of patients

Questionnaire

Description of clinical profile

Descriptive statistics using the proportion

Graphical presentation using pie chart and horizontal bar diagram

To compare the severity of symptoms pre-operatively and one week post-operatively

Questionnaire

Distribution of the symptomatics

Percent symptomatic

McNemar Change test Chi-square

To determine the success rate of the symptoms at three-month follow-up and six-month follow up

Questionnaire

Distribution of symptoms

Success rate

INTRODUCTION

Topic Background: "What is the topic all about?"

Nasal polyposisis the most common benign intranasal mass with multifactorial etiology. The course of the disease isburdensome to our patients and the managementremains a challenge to the treating physician . The treatment modalities of nasal polyposis are both medical and surgeryfollowing the assessment of the patient. Medical management affords symptomatic relief but the promise of medical polypectomy remains controversial.The traditional polypectomy and ethmoidectomyprovide high recurrence rate of about 50% with a possibility of catastrophiccomplications such as blindness and cerebrospinal fluid leakdue to the complexparanasal sinus anatomy.1 All these shortcomings of the traditional surgery are overcome bythe advent of endoscopic sinus surgerybecoming a popular surgical approach for nasal polyposis.

At present, the Department of Otorhinolaryngology- Head and Neck Surgery(ORLHNS) of the Southern Philippines Medical Center(SPMC) formerly Davao Medical Center(DMC)3 year census review appeared that nasal polyposis showed30 - 39%of the totalsinonasal elective admissions and 16 - 23%of the totalsinonasal outpatient cases.2 Forty percent of such elective admissions are recurrent from a previous polypectomy.2The SPMC- ORLHNS department isgeared towards such advances insinus surgery through endoscopy since 2003.However, there has been no local study yet ever done as to evaluate and assess the outcomes of endoscopic sinus surgery in this institution.

Review of Related Literature: "What is already known about the topic?"

Endoscopic sinus surgery (ESS) has revolutionized the management of sinus diseases.The concept of nasal endoscopy has existed for almost a century, however, it was not utilized as a surgical approach to the paranasal sinuses until the late 1970s.3 The procedure performed endoscopically increases after Kennedy introduced this approach in the United States in 1984.4Currently, there are existing numberof literatures on the objective and symptom specific efficacy of both medical and surgical interventions for paranasalsinus diseases.

Hirschmann in 1901 using modified cystoscope performed the first sinonasal endoscopy. Since then, many advances have been made in the field of endoscopic sinus surgery until during 1970's whenProfessors Messerklinger and Wigand introduced the procedure and later popularized in Europe by Stammberger and subsequently in North America by Kennedy.The use of this approach has become more popular with improvement in the understanding of the anatomical variation of lateral nasal wall and osteomeatal complex According to Messerklinger theory , that the anatomical variationscould cause obstruction of both drainage and ventilation of the sinuses, initiated the development of a functionally oriented surgical approach.5 Theendoscopic sinus surgery technique provides better tool foraccurate diagnose,and carefully perform surgery and provide better post-operative care and follow up for paranasal sinus diseases.

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The pathophysiology of chronic sinonasaldisease has been elucidated through the work of Professor Messerklinger.6He noted that the mucosal changes that meatus, maxillary ostium, infundibulum, uncinate process, ethmoid bullae, and hiatus semilunaris) resolvewhen normal ventilation and mucociliary clearance is restored. This knowledge has led to the acceptance of endoscopic sinus surgery as a valuable modality in the surgical management of sinus disorders.

Based on his investigation, the indications for endoscopic sinus surgery have expanded to include not only the management of sinus infection resistant to medical management,but also the treatment of nasal polyposis, and surgical management ofbenign and well-localized malignant neoplasms. Endoscopy also providesexcellent modality for nasal examination.7

Conventional Endoscopic Sinus Surgery( ESS) have transformed all of the surgical specialties not only confined to paranasal sinuses like inflammatory sinus diseases, bebign and selected malignant sinonasal tumors but also expanded its application to the treatment of cranial base pathology, most commonly the cerebrospinal leaks and pituitary tumors.8,9,10 However, the advanced technology entails proper training to prevent unnecessary morbidity and achieve good outcomes.11

Endoscopic Sinus Surgery has been accepted as minimally invasive technique for the treatment of nasal polyposis resistant to medical therapy.6 Different studies have been done to show comparison in the outcomesthrough complications by Stammberger in 1990, Hosemann in 1991, Vleming in 1992 and the Fageeh et al study 1996.Outcomes such as synechiae, loss of smell, orbital hematoma, blindness, bleeding, cerebrospinal fluid leak, internal carotid and death are extremes.Synechiae remains to be the most common complications in the study presented by Stammberger and Fageeh and bleeding as the second most common.History remains the most important factor in predicting the patients outcome and benefits from ESS.6Patient's comorbidities, surgeons training and expertise and institutional resources are potential limitation in the outcome of the procedure.11 Although the Messerklinger approach was used by all surgeons, the availability of resources may be a limitation.Almost all tertiary institutions are accessible to thestate of the art instrument such as microdebrider and the liketo improve the outcome of the surgery.

At present, the Department of Otorhinolaryngology- Head and Neck Surgery of Davao Medical Center now Southern Philippines Medical Center geared towards such advances insinus surgery through endoscopy since 2003.However, with the limitation of resoursesthere has been no local study yet ever done as to evaluate and assess the outcome of endoscopic sinus surgery in this institution and compare its outcome to other institution.

Research Question: "What is not yet known about the topic?"

General question

What are the outcomes the outcomes of patients undergoing endoscopic sinus surgery(ESS) from January2009 - June 2010 inSouthern Philippines Medical Center?

Sub-question

What arethe demographic and clinicalprofiles of the patients who will undergo endoscopic sinus surgery?

What are the changes in symptoms' scoring, preoperative Paranasal sinus(PNS) CT scan staging, endoscopic evaluation preoperatively, 1 week, 3 months, and 6 months posoperatively?

What are the complications that patients experience after ESS?

What is the success rate of ESSbased on symptoms scoring outcome, endoscopic evaluation, and complications at three-month follow-up and six-month follow up?

Significance of the Study: "What will healthcare be if the answers to the research questions will be known?

The impact ofoutcome measurement in evaluating themanagement modalities of nasal Polyposismay be limited when the outcome measurement is dependent only in the disease-specific impact on patients perception of disability. Kennedy et al in 1989 outlined form which is regarded asdisease-specific, self reported outcome measurement tool, which is the standard protocol in most institutions in the world including our local institution. We will evaluate the outcome of patients with nasal polyposisthat will undergo ESS based on symptoms scoring, CT scan evaluation, pre and post operative endoscopic evaluation and complications in two year period in Davao Medical Center now Southern Philippines Medical Center.

This study willdirect us to determine the status of endoscopic sinus surgery in our institution despite the limited surgical logistics compared to other institutionalized studies with accessible andmore availableinstrumentation.At the same time, this study will standardize guidelines in the approach to nasal polyposismanagement inour institution.

Objectives: "What will the study do?"

General:

To determine the outcome of patients undergoing endoscopic sinus surgery from January2009 - December 2010 in Southern Philippines Medical

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Specific:

To describe the demographic profile of the patients in terms of

Age

Sex

Occupation

To describe the clinical profile of patients in terms of:

Chief complaints ( nasal congestion, nasal obstruction, nasal discharge( rhinorrhea), loss of smell, sneezing, headache, facial pain, others( epistaxis, cough, hyponasal speech, mouth breathing, halitosis.)

History of the disease( recurrence, type and year of surgery, anesthesia, history of allergy and asthma)

History of concurrent medical conditions( Diabetes, hypertension, asthma, others)

History of previous and concurrent medication( side effects,)

CT Scan staging of the patient( Lund-Mackay system)

Physical examination( Endoscopic sinuscopy)

laterality ( unilateral, bilateral)

grade( 1, 2, 3 )

To compare the severity of symptoms pre-operatively and one week post-operatively in terms of:

Nasal obstruction

Nasal discharge

Nasal bleeding

Recurrent infection

Headache

Lost of smell

Facial pain

Facial pressure

Post nasal drip

To determine the success rate of the symptoms at three-month follow-up and six-month follow up in terms of:

Nasal obstruction

Nasal discharge

Nasal bleeding

Recurrent infection

Headache

Lost of smell

Facial pain

Facial pressure

Post nasal drip

To describe results of endoscopic reevaluate and reported complications of patients at 1 week, 3 months, and 6 months.

Methodology

Study Design

Abefore and after study design will be utilized.

Setting

Patients admitted at Southern Philippines Medical Center for ESS from the period January 2009 to December 2010will be included.

Participants

The study will include all patients seen and indicated for surgery in the sinus clinic,diagnosed withnasal polyposis clinically or histopathologically who meet all the following inclusion criteria:

Either unilateral or bilateral

Endoscopically grade 2 to 3 polyp based on Mackay Classification

Either initial or recurrent

Failed medical treatment for 3 months

Either sex above 16 years of age with preoperative paranasal sinus CT scan

Admitted from January 1, 2009 to December 31, 2010

And none of the following exclusion criteria:

Patients having antrochoanal polyp

Patients with markedly deviated nasal septum and premalignant and malignant lesions. Patients having antrochoanal polyp, marked deviated nasal septum and premalignant and malignant lesions were excluded from the study.

Baseline Data Collection

Initial patient work-up included detailed history taking about the symptoms and their duration. Thereafter, complete ENT examination including anterior rhinoscopy via endoscopy, posterior rhinoscopy, throat and ear examination will bedone.

A questionnaire will be given to patients to grade the severity of their symptoms (nasal obstruction, nasal discharge, nasal bleeding, recurrent infection, headache, loss of smell, facial pain, facial pressure and posterior nasal drip) before and after surgery (See Questionnaire, annex A). The patient's symptoms on presentation will be studied, and each symptom will be graded 0 to 3 (0 denoted none, 1 mild, 2 moderate and 3, severe problems.)

Description of Surgical Intervention

The extent of surgery will bebased on the findings in pre-operative CT scan of paranasal sinuses.The endoscopic evaluation will be graded based onMackay Classification. Grade 1 polyps are those that do not prolapse beyond middle turbinates, grade 2 are those that extend below middle turbinates, and grade 3 are those massive and occluding the entire nasal cavity.

A standardized procedure of polypectomy, anterior ethmoidectomy, posterior ethmoidectomy, middle meatus antrostomy and clearance of frontal recess will be performed in all the patients. Along with this any significant anatomical abnormality will be a noted and taken cared of during surgery. A week systemic oral antibiotic and oral steroid will be given to all populationpre-operatively.The patients will be given systemic antibiotic for 10 days upon discharge. Steroid nasal spray andalkaline nasal douching will be advised in all cases.

Outcome Measures and Follow- Up

Baseline symptom questionnaire and symptom scoring will be repeated at 1 week, 3 weeks and 6 months. Postoperative symptoms will also beevaluated.Each symptom will be reassessed and graded in severity frommuch worse (-2), worse (-1), no change (0), better (1+) or much better (+2). Follow up endoscopic evaluation is done to monitor recurrences.Minor and major, immediate and long term complications as described by Cummings( See appendix A)will be noted by the investigator.

Sample Size Computation

Total enumeration of patients admitted who are diagnosed with nasal polyposis and indicated for surgery in the sinus clinic will be done.

Data Analysis

Descriptive statistics will be used to summarize data.Comparison of continuous variable will be done using the t- test.Comparison of categorical variables will be done using the chi-square test.

Ethical Consideration

Permission to conduct study

As soon as the permission from the hospital management to conduct the study is granted, permission will be sought from the individual participants who are included in the study.The investigator will personally solicit the informed consent to the study participants and this may take about twenty minutes in order to complete the whole process of collection of informed consent. The participating individual will be requested to read the informed consent initially, after which the investigators will discuss all portions of the informed consent to the participants.The participants will be allowed to raise questions to the investigator on anything related to the study.All participants will be informed that they are allowed to withdraw participation in the two components of the study i.e.,medical check-up andlaboratory procedure.They will be informed that they are given the privilege to withdraw anytime in these research components of the study without necessarily be denied of the benefits related to the study, i.e. medical check-up and laboratory procedures.The study participants are reassured of their confidentiality.After the informed consent has been discussed well, the participants will sign the consent as a gesture that they understood the study and agreed to participate.A witness will also sign to signify that the participant understood the study and that the participant agrees to undergo and be part of the study. Participants who are less than 18 years old will have their mothers as witnesses. A prepared informed consent shall be used for this purpose (see Patient Information and Informed Consent, Appendix B).

Data management

This involves the following procedures: editing (checking the questionnaire), and storing of data files.

Questionnaire

After each interview, the questionnaire shall be immediately checked by the data collector.Upon arrival at the processing site, all questionnaires will be again inspected by the investigator.The investigator will personally encode the data into the computer for data analysis.After encoding, the questionnaires shall be kept and archived in data storage area.This shall be safeguarded for a period of five years, after which, all questioannaires shall be disposed of by shredding.Only the investigator shall have the access to the data.

For the purpose of confidentiality, each questionnaire shall be number-coded and only the code shall be stored in the statistical software for reference.

Electronic copy

The electronic files shall be stored in a data storage gadget (USB stick or CD) and shall be kept in the data storage area together with the questionnaires.After five years, the saved data shall be deleted and the gadget be disposed.

Photodocumentation

The investigator shall ask the permission of the patient that he may be allowed to take photodocumentation.This shall be included in the informed consent.Only those who readily agree to the photodocumentation be included.

Data Analysis Plan

The dummy tables below will be used as a guide for data analysis

Table 1.Distribution of Patients According to Selected Demographic Profile

Demographic Profile

Freq

%

Age

<20

21 - 30

31 - 40

41 - 50

51 - 60

60 and above

Total

Sex

Male

Female

Total

Occupation

Table 2. Distribution of Patients According to Clinical Profile

Clinical Profile

Freq

%

Chief complaint

nasal congestion

Nasal obstruction

Nasal discharge/rhinorrhea

Loss of smell

Sneezing

Headache

Facial pain

Epistaxis

Cough

Hyponasal speech

Mouth breathing

Halitosis

History of the disease

Recurrent mass

Date of Previous Surgery

Type of Surgery

PEA

ESS

Local Anesthesia

General Anesthesia

History ofasthma

History ofallergy

Concurrent Medical condition

Diabetes Mellitus

Hypertension

Asthma

Others :

Physical examination

Unilateral mass

Bilateral mass

Grade 1

2

3

Table 3.Distribution of Patients According to Pre-operative Symptoms

Symptom

No problem

0

Mild

1

Moderate

2

Severe

3

Total Symptomatic

1+2+3

Nasal Obstruction

Nasal discharge

Nasal bleeding

Recurrent infection

Headache

Loss of smell

Facial pain

Facial pressure

Post-nasal drip

Table 4.Distribution of Patients According to Post-operative Symptoms

Symptom

No problem

0

Mild

1

Moderate

2

Severe

3

Total Symptomatic

1+2+3

Nasal Obstruction

Nasal discharge

Nasal bleeding

Recurrent infection

Headache

Loss of smell

Facial pain

Facial pressure

Post-nasal drip

Table 5.Comparison of Occurrence of Symptoms Pre-Operatively and Post-Operatively

Pre-operative

Post-operative

Chi square

p-value

Total symptomatic

Total asymptomatic

Total symptomatic

Total asymptomatic

Table 6.Distribution of Patients According to Pre-operative Symptoms

Symptom

Much worse

-2

Worse

-1

No change

0

Better

1

Much Better

2

Success Rate

Nasal Obstruction

Nasal discharge

Nasal bleeding

Recurrent infection

Headache

Loss of smell

Facial pain

Facial pressure

Post-nasal drip

Table 7.CT Scan grading of the patient based on Lund-Mackay System.

0 Points - No abnormality

1 Point- Partial Opacification

2 Points - Total Opacification

Right Side

Left Side

Maxillary Sinus

Anterior Ethmoid Sinus

Posterior Ethmoid Sinus

Sphenoid Sinus

Frontal Sinus

Osteomeatal Complex

TOTAL

Score 0,1 or 2 points for left and right sides of each following region and calculate total of each side. Osteomeatal Complex is scored only with 0 or 2.

Metson et al.

Table 8.Distribution of Patients with SymptomChanges after Three Months

Symptom

Much worse

-2

Worse

-1

No change

0

Better

1

Much Better

2

Success Rate

Nasal Obstruction

Nasal discharge

Nasal bleeding

Recurrent infection

Headache

Loss of smell

Facial pain

Facial pressure

Post-nasal drip

Table 9.Distribution of Patients with Symptom Changes after Six Months

Symptom

Much worse

-2

Worse

-1

No change

0

Better

1

Much Better

2

Success Rate

Nasal Obstruction

Nasal discharge

Nasal bleeding

Recurrent infection

Headache

Loss of smell

Facial pain

Facial pressure

Post-nasal drip