Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

May 30, 2023 updated by: Olli-Pekka Alho, MD, Oulu University Hospital

A Randomised Controlled Study of Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis

The aim of this study is to find out if endoscopic sinus surgery improves the quality of life in patients suffering from recurrent acute rhinosinusitis. Our main outcome is the difference between the average change in disease-specific SNOT-22 quality of life questionnaire scores (from baseline to 5-6 months follow-up) between the intervention and the control groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized controlled trial. Patients suffering from recurrent acute sinusitis episodes will be randomly allocated to two groups: intervention group, where they will receive endoscopic sinus surgery in addition to medical treatment and control group, where they will receive mere medical treatment. Both groups will be followed-up for 5 to 6 months. At baseline and after 5 to 6 months, patients will answer the life quality questionnaires SNOT-22 and RAND 36-item Health Survey. The numbers of sinusitis episodes, medical appointments for respiratory symptoms, use of medications, numbers of days lost from work or studies and numbers of days with various respiratory and adverse symptoms will be recorded with patient diaries. The potential serious adverse events (e.g. cerebrospinal fluid leak, orbital complications) related to surgery will be collected from the medical records.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Finland
      • Oulu, Finland
      • Tampere, Finland
        • Recruiting
        • Tampere University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Saara Sillanpää, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitis episodes during previous 12 months or at least 2 episodes per year for 3 consecutive years
  • Episodes must last less than 4 weeks and be diagnosed and treated as acute rhinosinusitis by a physician
  • Episode symptoms include nasal discharge, nasal congestion, hyposmia and facial pressure or pain and the episodes have to be severe enough for the patient to seek medical help and for daily life to be significantly disturbed
  • Patients must have failed a three-month conservative therapy (medication for possible allergies, nasal corticosteroids and douching and courses of antibiotics as necessary)

Exclusion Criteria:

  • Age under 18 years,
  • Immunodeficiency or immunosuppression
  • Pregnancy,
  • Previous illness making same-day surgery unfeasible
  • Ongoing antibiotic treatment for other reasons,
  • Primary complaint of nasal septal deviation and
  • Chronic rhinosinusitis with or without nasal polyposis
  • Symptoms for over 12 weeks and/or Lund-Mackay score over 8 in paranasal sinus CBCT scanning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Endoscopic sinus surgery (ESS)
Endoscopic sinus surgery. Postoperative treatment consists of daily nasal douching, daily nasal steroid sprays, pain medication when necessary and at least one postoperative control visit including endoscopy two weeks after the operation. Additionally medical treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary.
Procedure: Endoscopic sinus surgery (ESS)
Uncinectomy, middle meatal antrostomy by enlarging the natural maxillary ostium and partial ethmoidectomy or septoplasty according to clinical evaluation of the operator.
No Intervention: Control
Conservative treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sinonasal Outcome Test-22 score
Time Frame: 5-6 months
Difference between the mean disease-specific Sinonasal Outcome Test 22 (SNOT-22) change scores (from baseline to 5-6 months) of ESS and control group. SNOT-22 summary scores vary between 0 and 110 with higher values indicating poorer quality of life.
5-6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
36-Item Short Form Survey (SF-36, RAND) score
Time Frame: 5-6 months
Difference between the mean generic RAND-36 domains change scores (from baseline to 5-6 months) of ESS and control group. RAND-36 instrument produces eight individual values between 0 and 100 (one for each domain), with higher scores indicating better quality of life.
5-6 months
Difference in proportions of patients benefiting
Time Frame: 5-6 months
Difference in proportions of patients benefiting clinically significantly from the treatment in ESS and control group (Minimum important change in SNOT-22 score)
5-6 months
Difference in numbers of sinusitis episodes
Time Frame: 5-6 months
Difference in the numbers of sinusitis episodes between the ESS and control groups.
5-6 months
Difference in numbers of medical visits
Time Frame: 5-6 months
Difference in the numbers of medical visits between the ESS and control groups.
5-6 months
Difference in numbers of antimicrobial treatments
Time Frame: 5-6 months
Difference in the numbers of antimicrobial treatments between the ESS and control groups.
5-6 months
Difference in numbers of days lost from work or studies
Time Frame: 5-6 months
Difference in the numbers of days lost from work or studies between the ESS and control groups.
5-6 months
Difference in numbers of days with nasal obstruction
Time Frame: 5-6 months
Difference in the numbers of days with nasal obstruction between the ESS and control groups.
5-6 months
Difference in numbers of days with nasal discharge
Time Frame: 5-6 months
Difference in the numbers of days with nasal discharge between the ESS and control groups.
5-6 months
Difference in numbers of days with facial pain or pressure
Time Frame: 5-6 months
Difference in the numbers of days with facial pain or pressure between the ESS and control groups.
5-6 months
Difference in numbers of days with nasal pain
Time Frame: 5-6 months
Difference in the numbers of days with nasal pain between the ESS and control groups.
5-6 months
Difference in numbers of days with nasal hemorrhage
Time Frame: 5-6 months
Difference in the numbers of days with nasal hemorrhage between the ESS and control groups.
5-6 months
Difference of numbers of days with fever
Time Frame: 5-6 months
Difference in the numbers of days with fever (>37.5 Celsius) between the ESS and control groups.
5-6 months
Adverse effects - postoperative synechia formation
Time Frame: 5-6 months
Frequency of postoperative synechia formations in the ESS group
5-6 months
Adverse effects - postoperative infection
Time Frame: 5-6 months
Frequency of postoperative infections in the ESS group
5-6 months
Adverse effects - postoperative orbital complication
Time Frame: 5-6 months
Frequency of postoperative orbital complications in the ESS group
5-6 months
Adverse effects - postoperative intracranial complication
Time Frame: 5-6 months
Frequency of postoperative intracranial complications in the ESS group
5-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oulu University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tampere University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olli-Pekka Alho, MD, PhD, Oulu University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01234

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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