CLINICAL TRIAL

Endoscopic Polypectomy Performed in Clinic for Sinusitis

Waitlist Available · 18+ · All Sexes · Barrie, Canada

This study is evaluating whether a procedure that is done in the clinic is as good as the surgery done in the operating room.

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About the trial for Sinusitis

Eligible Conditions
Sinusitis · Polyps · Nasal Polyps

Treatment Groups

This trial involves 2 different treatments. Endoscopic Polypectomy Performed In Clinic is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Endoscopic Polypectomy Performed in Clinic
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Functional Endoscopic Sinus Surgery (FESS)
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
An individual who is 18 years or older is legally considered an adult show original
The subject has bilateral nasal polyps that are Grade ≥ 2 on each side, as determined by the Lildholdt scale score measured by nasal endoscopy. show original
A patient must have a nasal blockage score of greater than or equal to 4 on the sinonasal outcome test SNOT-22 at the screening visit in order to be eligible for the study. show original
Must have an American Society of Anesthesiologists physical status (ASA PS) 3 classification or less. ASA PS 3: Patients with severe systemic disease: Some functional limitation; has a controlled disease of more than one body system or one major system; no immediate danger of death. ASA PS 2: Patients with mild systemic disease. No functional limitations; has a well-controlled disease of one body system. ASA PS 1: Normal healthy patient. No organic, physiologic, or psychiatric disturbance; excludes the very young and very old.
Participants with comorbid asthma or chronic obstructive pulmonary disease (COPD) must have stable disease with no exacerbations (no emergency room visits, hospitalisations, or oral or parental steroid use for these lower respiratory conditions) within 3 months before the screening visit.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: One year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: One year.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Endoscopic Polypectomy Performed in Clinic will improve 1 primary outcome and 2 secondary outcomes in patients with Sinusitis. Measurement will happen over the course of Evaluated at 6 months after intervention.

Loss to follow up
EVALUATED AT 6 MONTHS AFTER INTERVENTION
Number of participants who do not complete the 6 month follow up period
Arm cross-over
ONE YEAR
Number of participants who switched arm
Rate of recruitment
ONE YEAR
Number of patients recruited in one year

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is sinusitis?

It could be classified as an inflammatory disease caused by bacterial infection of the paranasal sinuses. The most common type of infection is acute or chronic sinusitis caused by bacterial infections. It can occur alone or associate with other illnesses.\n

Anonymous Patient Answer

What are the signs of sinusitis?

The signs of acute sinusitis include: facial swelling, tender or sore throat, pain or stiffness when swallowing, and a clear, foul-smelling or foul odor. Signs of chronic sinusitis include: tiredness, loss of appetite, shortness of breath or cough. Sometimes patients with acute and chronic sinusitis develop the same symptoms.

Anonymous Patient Answer

What are common treatments for sinusitis?

The three most common treatments for sinusitis are surgical debridement, antibiotics, and nasal sprays. These three treatments together account for more than 90% of all surgical treatments for sinusitis in the USA.

Anonymous Patient Answer

Can sinusitis be cured?

In a recent study, findings of this pilot study suggest that, although sinusitis can be eliminated by surgical debridement, recurrence can occur after surgical removal. This finding suggests that additional prophylactic modalities must be considered to achieve and maintain a cure of recurrent cases.

Anonymous Patient Answer

How many people get sinusitis a year in the United States?

The number of cases of sinusitis in the US in 2002 was about 8 million cases of acute, chronic, and subacute sinusitis and is in the range of other estimates of sinusitis in other countries. These cases of acute sinusitis are seen in a general internist's office on an outpatient basis. In a population where many adults have been smoking, at least 10% have chronic sinusitis and 40% have chronic acute sinusitis. Chronic sinusitis is more common, especially in the elderly. This is the largest estimate of the number of sinusitis cases, other estimates may have larger numbers, but similar distribution of demographic, smoking, treatment, and morbidity among the groups.

Anonymous Patient Answer

What causes sinusitis?

Most sinusitis is caused by nonodontogenic processes and may be managed without antibiotics. However, some sinuses are infected by bacteria and may require antibiotics. The presence of other factors that increases the risk of sinusitis is still not fully understood. These factors include smoking, allergies, and eosinophilic sinusitis. Treatment is usually by antibiotics such as azithrocyanide or penicillin, combined with steroids such as prednisone.

Anonymous Patient Answer

What are the common side effects of endoscopic polypectomy performed in clinic?

Endoscopic polypectomy in clinic can be performed with a low complication rate. The [common side effects]] are swelling [24.7%], vomiting [16.1%], and dizziness [12.3%]. The incidence of hemorrhage and perforation was significantly higher after [ERCP] in clinic, but this has been declining recently. The severity of the [proximal] bleed was not influenced by the technique.

Anonymous Patient Answer

How serious can sinusitis be?

Patients with chronic sinusitis should not be neglected. Sinus surgery should be considered for patients with symptomatic chronic sinusitis. The use of antiflagrans is a very good option in many patients with chronic sinusitis.

Anonymous Patient Answer

What is the primary cause of sinusitis?

The most common etiologic factors in this group of patients were H. influenzae and a viral etiology. The frequency of specific sinusitis type varied significantly between groups.

Anonymous Patient Answer

Have there been any new discoveries for treating sinusitis?

More research is needed to better understand and diagnose sinus diseases. The treatments available for acute and chronic sinusitis have not changed. Current research is also urgently needed to assess new treatments for those with chronic sinusitis and treat those who have never responded to any treatments.

Anonymous Patient Answer

What is the latest research for sinusitis?

The advancement in research has led to a better understanding and understanding of the etiology, pathophysiology, symptomatology, diagnosis, and management of this disease. All the information provided here will undoubtedly be helpful in improving the quality of life of all people with this disease.

Anonymous Patient Answer

What are the latest developments in endoscopic polypectomy performed in clinic for therapeutic use?

In clinical practice, patients undergoing polypectomy procedures for therapeutic purpose using the ‘cobra knife’ system had a higher risk of complications because of the difficulty of operating properly in the narrow space of the sinus cavity. The most recent developments in endoscopic polypectomy performed in clinics for therapeutic use are reported to overcome the difficulties of maneuvering under direct magnification in a limited space.

Anonymous Patient Answer
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