Nasal polyps remain a important challenge to the handling doctor. The intervention modes of rhinal polyps encompass both medical and surgical modes following the appraisal of the patient. Surgical intervention comprises of polypectomy which has a high return rate, intranasal ethmoidectomy – a unsighted process.

All these defects are overcome by endoscopic fistula surgery ( ESS ) , which is fast going the surgical intervention of pick for rhinal polyp disease. The first effort at nasal and fistula endoscopy was performed by Hirschmann in 1901 utilizing modified cystoscope. Since so, many progresss have been made in the field of endoscopic fistula surgery.At present, the Department of Otorhinolaryngology- Head and Neck Surgery of Southern Philippines Medical Center geared towards such progresss in fistula surgery through endoscopy since 2003. However, there has been no local survey yet of all time done as to measure and measure the result of endoscopic fistula surgery in this establishment.

General quality of life ( QOL ) measuring tolls have been used to measure the impact of a assortment of ague and chronic unwellnesss but may be limited when used to mensurate the disease-specific impact on patients perceptual experience of disablement or the result from intervention. Therefore based on the signifier outlined by Kennedy et Al in 1989 which is regarded as disease-specific, ego reported outcome measuring tool, we will measure the symptom result of patients with rhinal polyposis that will undergo ESS in two twelvemonth period in Southern Philippines Medical Center.

Relationships of research aims, informations subtrates, operationally-defined variables and informations analyses

Aims

Data substrates

Operationally-defined variables

Analysiss

To depict the demographic profile of the patients who will undergo endoscopic fistula surgeryQuestionnaire-Mean age-Proportion of the distribution of sex and soldierly positionDescriptive statistics utilizing agencies and proportionsTo depict the clinical profile of patientsQuestionnaireDescription of clinical profileDescriptive statistics utilizing the proportionGraphic presentation utilizing pie chart and horizontal saloon diagramTo compare the badness of symptoms pre-operatively and one hebdomad post-operativelyQuestionnaireDistribution of the symptomaticsPercent diagnosticMcNemar Change test Chi-squareTo find the success rate of the symptoms at three-month follow-up and six-month follow upQuestionnaireDistribution of symptomsSuccess rate

OUTCOMES OF ENDOSCOPIC SINUS SURGERY IN SOUTHERN PHILIPPINES MEDICAL CENTER

A Research Protocol

Presented to the

Department of Otorhinolaryngology- Head and Neck Surgery

Southern Philippines Medical Center

In Partial Fulfillment

Of the Requirement for Residency Training

Mohammad Ariff A. Baguindali, MD

Writer

Danilo R. Legita, MD, FPSO-HNS

Co- writer

Introduction

Subject Background: “ What is the subject all about? ”

Nasal polyposis is the most common benign intranasal mass with multifactorial etiology.

The class of the disease is burdensome to our patients and remains a important challenge to the handling doctor. The intervention modes of rhinal polyps encompass both medical and surgical modes following the appraisal of the patient. Medical direction affords diagnostic alleviation but the promise of medical polypectomy remains controversial.

The traditional polypectomy and ethmoidectomy provide high return rate of about 50 % with a possibility of ruinous complications such as sightlessness and cerebrospinal fluid leak due to the complex paranasal fistula anatomy.1 All these defects of the traditional surgery are overcome by the coming of Endoscopic Sinus Surgery, which is fast going the surgical intervention of pick for rhinal polyp disease.At present, the Department of Otorhinolaryngology- Head and Neck Surgery ( ORLHNS ) of the Southern Philippines Medical Center ( SPMC ) once Davao Medical Center ( DMC ) 3 twelvemonth nose count reappraisal appeared that rhinal polyposis showed 30 – 39 % of the entire sinonasal elected admittances and 16 – 23 % of the entire sinonasal outpatient cases.2 Forty per centum of such elected admittances are perennial from a old polypectomy.2 The SPMC- ORLHNS section is geared towards such progresss in fistula surgery through endoscopy since 2003. However, there has been no local survey yet of all time done as to measure and measure the results of endoscopic fistula surgery in this establishment.

Review of Related Literature: “ What is already known about the subject? ”

Endoscopic fistula surgery ( ESS ) has revolutionized the direction of fistula diseases. The construct of rhinal endoscopy has existed for about a century, nevertheless, it was non utilized as a surgical attack to the paranasal sinuses until the late 1970s.

3 The process performed endoscopically additions after Kennedy introduced this attack in the United States in 1984.4 Presently, there are bing figure of literatures on the aim and symptom specific efficaciousness of both medical and surgical intercessions for paranasal fistula diseases.Hirschmann in 1901 utilizing modified cystoscope performed the first sinonasal endoscopy. Since so, many progresss have been made in the field of endoscopic fistula surgery until during 1970 ‘s when Professors Messerklinger and Wigand introduced the process and subsequently popularized in Europe by Stammberger and later in North America by Kennedy. The usage of this attack has become more popular with betterment in the apprehension of the anatomical fluctuation of sidelong nasal wall and osteomeatal complex Harmonizing to Messerklinger theory, that the anatomical fluctuations could do obstructor of both drainage and airing of the fistulas, initiated the development of a functionally oriented surgical approach.5 The endoscopic fistula surgery technique provides a tool by which the clinician can accurately name, and carefully execute surgery and exactly supply post-operative attention and follow up for paranasal fistula diseases.The pathophysiology of chronic sinonasal disease has been elucidated through the work of Professor Messerklinger.

6 He noted that the mucosal changes that meatus, maxillary ostium, infundibulum, uncinate procedure, ethmoid blister, and hiatus semilunaris ) resoluteness when normal airing and mucociliary clearance is restored. This cognition has led to the credence of endoscopic fistula surgery as a valuable mode in the surgical direction of fistula upsets.Based on his probe, the indicants for endoscopic fistula surgery have expanded to include non merely the direction of fistula infection resistant to medical direction, but besides the intervention of rhinal polyposis, and surgical direction of benign and well-localized malignant tumors. Endoscopy besides provides first-class mode for rhinal examination.7Conventional Endoscopic Sinus Surgery ( ESS ) have transformed all of the surgical fortes non merely confined to paranasal fistulas like inflammatory fistula diseases, bebign and selected malignant sinonasal tumours but besides expanded its application to the intervention of cranial base pathology, most normally the cerebrospinal leaks and pituitary tumors.

8,9,10 However, the advanced engineering entails proper preparation to forestall unneeded morbidity and accomplish good outcomes.11Endoscopic Sinus Surgery has been accepted as minimally invasive technique for the intervention of rhinal polyposis resistant to medical therapy.6 Different surveies have been done to demo comparing in the results through complications by Stammberger in 1990, Hosemann in 1991, Vleming in 1992 and the Fageeh et Al survey 1996. Results such as synechiae, loss of odor, orbital haematoma, sightlessness, hemorrhage, cerebrospinal fluid leak, internal carotid and decease are extremes. Synechiae remains to be the most common complications in the survey presented by Stammberger and Fageeh and hemorrhage as the 2nd most common. History remains the most of import factor in foretelling the patients outcome and benefits from ESS.

6 Patient ‘s comorbidities, sawboness preparation and expertness and institutional resources are possible restriction in the result of the procedure.11 Although the Messerklinger attack was used by all sawboness, the handiness of resources may be a restriction. Almost all third establishments are accessible to the province of the art instrument such as microdebrider and the similar to better the result 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 progresss in fistula surgery through endoscopy since 2003. However, with the restriction of resourses there has been no local survey yet of all time done as to measure and measure the result of endoscopic fistula surgery in this establishment and compare its result to other establishment.

Research Question: “ What is non yet known about the subject? ”

General inquiryWhat are the results the results of patients undergoing endoscopic fistula surgery ( ESS ) from January2009 – June 2010 in Southern Philippines Medical Center?Sub-questionWhat are the demographic and clinical profiles of the patients who will undergo endoscopic fistula surgery?What are the alterations in symptoms ‘ marking, preoperative Paranasal fistula ( PNS ) CT scan theatrical production, endoscopic rating preoperatively, 1 hebdomad, 3 months, and 6 months posoperatively?What are the complications that patients experience after ESS?What is the success rate of ESS based on symptoms hiting result, endoscopic rating, and complications at three-month follow-up and six-month follow up?

Significance of the Study: “ What will healthcare be if the replies to the research inquiries will be known?

The impact of outcome measuring in measuring the direction modes of rhinal Polyposis may be limited when used to mensurate the disease-specific impact on patients perceptual experience of disablement or the result from intervention. Therefore based on the signifier outlined by Kennedy et Al in 1989 which is regarded as disease-specific, ego reported outcome measuring tool, which is the standard protocol in most establishments in the universe and the same protocol our local guideline penchant, we will measure the result of patients with rhinal polyposis that will undergo ESS based on symptoms hiting, CT scan rating, pre and station operative endoscopic rating and complications in two twelvemonth period in Davao Medical Center now Southern Philippines Medical Center.This survey will direct us to find the position of endoscopic fistula surgery in our establishment despite the limited surgical logistics compared to other institutionalised surveies with accessible and more available instrumentality.

At the same clip, this survey will standardise guidelines in the attack to nasal polyposis direction in our establishment.

Aims: “ What will the survey make? ”

General:To find the result of patients undergoing endoscopic fistula surgery from January2009 – December 2010 in Southern Philippines MedicalSpecific:To depict the demographic profile of the patients in footings ofAgeSexual activityOccupationTo depict the clinical profile of patients in footings of:Chief ailments ( rhinal congestion, rhinal obstructor, rhinal discharge ( rhinorrhea ) , loss of odor, sneezing, concern, facial hurting, others ( epistaxis, cough, hyponasal address, oral cavity external respiration, halitosis. )History of the disease ( return, type and twelvemonth of surgery, anaesthesia, history of allergic reaction and asthma )History of coincident medical conditions ( Diabetes, high blood pressure, asthma, others )History of old and coincident medicine ( side effects, )CT Scan theatrical production of the patient ( Lund-Mackay system )Physical scrutiny ( Endoscopic sinuscopy )lateralization ( one-sided, bilateral )class ( 1, 2, 3 )To compare the badness of symptoms pre-operatively and one hebdomad post-operatively in footings of:Nasal obstructorNasal dischargeNasal hemorrhagePerennial infectionConcernLost of odorFacial hurtingFacial force per unit areaPost nasal trickleTo find the success rate of the symptoms at three-month follow-up and six-month follow up in footings of:Nasal obstructorNasal dischargeNasal hemorrhagePerennial infectionConcernLost of odorFacial hurtingFacial force per unit areaPost nasal trickleTo depict consequences of endoscopic reevaluate and reported complications of patients at 1 hebdomad, 3 months, and 6 months.

Methodology

Study Design

A before and after survey design will be utilized.

Puting

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

Participants

The survey will include all patients seen and indicated for surgery in the fistula clinic, diagnosed with rhinal polyposis clinically or histopathologically who meet all the undermentioned inclusion standards:Either one-sided or bilateralEndoscopically grade 2 to 3 polyp based on Mackay ClassificationEither initial or recurrentFailed medical intervention for 3 monthsEither sex above 16 old ages of age with preoperative paranasal fistula CT scanAdmitted from January 1, 2009 to December 31, 2010And none of the undermentioned exclusion standards:Patients holding antrochoanal polypPatients with markedly deviated rhinal septum and premalignant and malignant lesions. Patients holding antrochoanal polyp, marked deviated rhinal septum and premalignant and malignant lesions were excluded from the survey.

Baseline Data Collection

Initial patient work-up included elaborate history taking about the symptoms and their continuance. Thereafter, complete ENT scrutiny including anterior rhinoscopy via endoscopy, posterior rhinoscopy, pharynx and ear scrutiny will be done.A questionnaire will be given to patients to rate the badness of their symptoms ( rhinal obstructor, rhinal discharge, rhinal hemorrhage, perennial infection, concern, loss of odor, facial hurting, facial force per unit area and posterior rhinal trickle ) 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 centrist and 3, terrible jobs.

)

Description of Surgical Intervention

The extent of surgery will be decided based on the findings in pre-operative CT scan of paranasal fistulas. The endoscopic rating will be graded based on Mackay Classification. Rate 1 polyps are those that do non prolapse beyond in-between turbinals, grade 2 are those that extend below in-between turbinals, and grade 3 are those monolithic and obstructing the full nasal pit.A standardised process of polypectomy, anterior ethmoidectomy, posterior ethmoidectomy, in-between meatus antrostomy and clearance of frontal deferral will be performed in all the patients. Along with this any important anatomical abnormalcy will be a celebrated and taken cared of during surgery.

A hebdomad systemic unwritten antibiotic and unwritten steroid will be given to all population pre-operatively. At the clip of discharge from the infirmary, the patients will be given systemic antibiotic for 10 yearss. Steroid nasal spray and alkaline nasal douching will be advised in all instances.

Outcome Measures and Follow- Up

Baseline symptom questionnaire and symptom marking will be repeated at 1 hebdomad, 3 hebdomads and 6 months. Postoperative symptoms will besides be evaluated.

Each symptom will be reassessed and graded in badness from much worse ( -2 ) , worse ( -1 ) , no alteration ( 0 ) , better ( 1+ ) or much better ( +2 ) . Follow up endoscopic rating is done to supervise returns. Minor and major, immediate and long term complications as described by Cummings ( See appendix A ) will be noted by the research worker.

Sample Size Computation

Entire numbering of patients admitted who are diagnosed with rhinal polyposis and indicated for surgery in the fistula clinic will be done.

Datas Analysis

Descriptive statistics will be used to sum up informations. Comparison of uninterrupted variable will be done utilizing the t- trial. Comparison of categorical variables will be done utilizing the chi-square trial.

Ethical Consideration

Permission to carry on surveyEqually shortly as the permission from the infirmary direction to carry on the survey is granted, permission will be sought from the single participants who are included in the survey. The research worker will personally beg the informed consent to the survey participants and this may take about 20 proceedingss in order to finish the whole procedure of aggregation of informed consent. The take parting person will be requested to read the informed consent ab initio, after which the research workers will discourse all parts of the informed consent to the participants.

The participants will be allowed to raise inquiries to the research worker on anything related to the survey. All participants will be informed that they are allowed to retreat engagement in the two constituents of the survey i.e. , medical check-up and laboratory process. They will be informed that they are given the privilege to retreat anytime in these research constituents of the survey without needfully be denied of the benefits related to the survey, i.e. medical check-up and research lab processs.

The survey participants are reassured of their confidentiality. After the informed consent has been discussed good, the participants will subscribe the consent as a gesture that they understood the survey and agreed to take part. A informant will besides subscribe to mean that the participant understood the survey and that the participant agrees to undergo and be portion of the survey. Participants who are less than 18 old ages old will hold their female parents as informants. A prepared informed consent shall be used for this intent ( see Patient Information and Informed Consent, Appendix B ) .Data directionThis involves the undermentioned processs: redaction ( look intoing the questionnaire ) , and storing of informations files.QuestionnaireAfter each interview, the questionnaire shall be instantly checked by the informations aggregator. Upon reaching at the processing site, all questionnaires will be once more inspected by the research worker.

The research worker will personally encode the information into the computing machine for informations analysis. After encoding, the questionnaires shall be kept and archived in informations storage country. This shall be safeguarded for a period of five old ages, after which, all questioannaires shall be disposed of by tear uping. Merely the research worker shall hold the entree to the informations.For the intent of confidentiality, each questionnaire shall be number-coded and merely the codification shall be stored in the statistical package for mention.

Electronic transcriptThe electronic files shall be stored in a information storage appliance ( USB stick or Cadmium ) and shall be kept in the informations storage country together with the questionnaires. After five old ages, the saved informations shall be deleted and the appliance be disposed.PhotodocumentationThe research worker shall inquire the permission of the patient that he may be allowed to take photodocumentation. This shall be included in the informed consent. Merely those who readily agree to the photodocumentation be included.

Datas Analysis Plan

The dummy tabular arraies below will be used as a usher for informations analysis

Table 1. Distribution of Patients Harmonizing to Selected Demographic Profile

Demographic Profile

Freq

%

Age& lt ; 2021 – 3031 – 4041 – 5051 – 6060 and aboveEntireSexual activityMaleFemaleEntireOccupation

Table 2. Distribution of Patients Harmonizing to Clinical Profile

Clinical Profile

Freq

%

Chief ailmentnasal congestionNasal obstructorNasal discharge/rhinorrheaLoss of odorSneezingConcernFacial hurtingNosebleedCoughHyponasal addressMouth external respirationHalitosisHistory of the diseasePerennial massDate of Previous SurgeryType of SurgeryPeaEinsteiniumLocal AnesthesiaGeneral AnesthesiaHistory of asthmaHistory of allergic reactionConcurrent Medical statusDiabetess MellitusHigh blood pressureAsthmaOthersA :Physical scrutinyUnilateral massBilateral massGrade 123

Table 3.

Distribution of Patients Harmonizing to Pre-operative Symptoms

SymptomNo job0Mild1Moderate2Severe3Entire Symptomatic1+2+3Nasal ObstructionNasal dischargeNasal hemorrhagePerennial infectionConcernLoss of odorFacial hurtingFacial force per unit areaPost-nasal trickle

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

SymptomNo job0Mild1Moderate2Severe3Entire Symptomatic1+2+3Nasal ObstructionNasal dischargeNasal hemorrhagePerennial infectionConcernLoss of odorFacial hurtingFacial force per unit areaPost-nasal trickle

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

Pre-operative

Post-operative

Chi square

p-value

Entire diagnosticEntire symptomlessEntire diagnosticEntire symptomless

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

Symptom

Much worse

-2

Worse

-1

No alteration

0

Better

1

Much Better

2

Success Rate

Nasal ObstructionNasal dischargeNasal hemorrhagePerennial infectionConcernLoss of odorFacial hurtingFacial force per unit areaPost-nasal trickle

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

0 Points – No abnormalcy

1 Point – Partial Opacification

2 Points – Entire Opacification

Right Side

Left Side

Maxillary SinusAnterior Ethmoid SinusPosterior Ethmoid SinusSphenoid SinusFrontal SinusOsteomeatal Complex

Sum

Score 0,1 or 2 points for left and right sides of each undermentioned part and calculate sum of each side.

Osteomeatal Complex is scored merely with 0 or 2.

Metson et Al.

Table 8. Distribution of Patients with SymptomChanges after Three Months

Symptom

Much worse

-2

Worse

-1

No alteration

0

Better

1

Much Better

2

Success Rate

Nasal ObstructionNasal dischargeNasal hemorrhagePerennial infectionConcernLoss of odorFacial hurtingFacial force per unit areaPost-nasal trickle

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

Symptom

Much worse

-2

Worse

-1

No alteration

0

Better

1

Much Better

2

Success Rate

Nasal ObstructionNasal dischargeNasal hemorrhagePerennial infectionConcernLoss of odorFacial hurtingFacial force per unit areaPost-nasal trickle

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