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Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

Primary Purpose

Maxillary Sinusitis, Sinusitis, Acute, Sinusitis

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Endoscopic sinus surgery (ESS)
Sponsored by
Oulu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Sinusitis focused on measuring adult, endoscopic sinus surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitis episodes during previous 12 months
  • 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 4 in paranasal sinus CBCT scanning

Sites / Locations

  • Oulu University HospitalRecruiting
  • Tampere University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Endoscopic sinus surgery (ESS)

Control

Arm Description

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.

Conservative treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary.

Outcomes

Primary Outcome Measures

Sinonasal Outcome Test-22 score
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.

Secondary Outcome Measures

36-Item Short Form Survey (SF-36, RAND) score
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.
Difference in proportions of patients benefiting
Difference in proportions of patients benefiting clinically significantly from the treatment in ESS and control group (Minimum important change in SNOT-22 score)
Difference in numbers of sinusitis episodes
Difference in the numbers of sinusitis episodes between the ESS and control groups.
Difference in numbers of medical visits
Difference in the numbers of medical visits between the ESS and control groups.
Difference in numbers of antimicrobial treatments
Difference in the numbers of antimicrobial treatments between the ESS and control groups.
Difference in numbers of days lost from work or studies
Difference in the numbers of days lost from work or studies between the ESS and control groups.
Difference in numbers of days with nasal obstruction
Difference in the numbers of days with nasal obstruction between the ESS and control groups.
Difference in numbers of days with nasal discharge
Difference in the numbers of days with nasal discharge between the ESS and control groups.
Difference in numbers of days with facial pain or pressure
Difference in the numbers of days with facial pain or pressure between the ESS and control groups.
Difference in numbers of days with nasal pain
Difference in the numbers of days with nasal pain between the ESS and control groups.
Difference in numbers of days with nasal hemorrhage
Difference in the numbers of days with nasal hemorrhage between the ESS and control groups.
Difference of numbers of days with fever
Difference in the numbers of days with fever (>37.5 Celsius) between the ESS and control groups.
Adverse effects - postoperative synechia formation
Frequency of postoperative synechia formations in the ESS group
Adverse effects - postoperative infection
Frequency of postoperative infections in the ESS group
Adverse effects - postoperative orbital complication
Frequency of postoperative orbital complications in the ESS group
Adverse effects - postoperative intracranial complication
Frequency of postoperative intracranial complications in the ESS group

Full Information

First Posted
January 17, 2020
Last Updated
May 30, 2023
Sponsor
Oulu University Hospital
Collaborators
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04241016
Brief Title
Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis
Official Title
A Randomised Controlled Study of Endoscopic Sinus Surgery for Recurrent Acute Rhinosinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oulu University Hospital
Collaborators
Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Sinusitis, Sinusitis, Acute, Sinusitis
Keywords
adult, endoscopic sinus surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic sinus surgery (ESS)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Conservative treatment including nasal corticosteroids, nasal douching and other allergy medication as necessary.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic sinus surgery (ESS)
Intervention Description
Uncinectomy, middle meatal antrostomy by enlarging the natural maxillary ostium and partial ethmoidectomy or septoplasty according to clinical evaluation of the operator.
Primary Outcome Measure Information:
Title
Sinonasal Outcome Test-22 score
Description
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.
Time Frame
5-6 months
Secondary Outcome Measure Information:
Title
36-Item Short Form Survey (SF-36, RAND) score
Description
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.
Time Frame
5-6 months
Title
Difference in proportions of patients benefiting
Description
Difference in proportions of patients benefiting clinically significantly from the treatment in ESS and control group (Minimum important change in SNOT-22 score)
Time Frame
5-6 months
Title
Difference in numbers of sinusitis episodes
Description
Difference in the numbers of sinusitis episodes between the ESS and control groups.
Time Frame
5-6 months
Title
Difference in numbers of medical visits
Description
Difference in the numbers of medical visits between the ESS and control groups.
Time Frame
5-6 months
Title
Difference in numbers of antimicrobial treatments
Description
Difference in the numbers of antimicrobial treatments between the ESS and control groups.
Time Frame
5-6 months
Title
Difference in numbers of days lost from work or studies
Description
Difference in the numbers of days lost from work or studies between the ESS and control groups.
Time Frame
5-6 months
Title
Difference in numbers of days with nasal obstruction
Description
Difference in the numbers of days with nasal obstruction between the ESS and control groups.
Time Frame
5-6 months
Title
Difference in numbers of days with nasal discharge
Description
Difference in the numbers of days with nasal discharge between the ESS and control groups.
Time Frame
5-6 months
Title
Difference in numbers of days with facial pain or pressure
Description
Difference in the numbers of days with facial pain or pressure between the ESS and control groups.
Time Frame
5-6 months
Title
Difference in numbers of days with nasal pain
Description
Difference in the numbers of days with nasal pain between the ESS and control groups.
Time Frame
5-6 months
Title
Difference in numbers of days with nasal hemorrhage
Description
Difference in the numbers of days with nasal hemorrhage between the ESS and control groups.
Time Frame
5-6 months
Title
Difference of numbers of days with fever
Description
Difference in the numbers of days with fever (>37.5 Celsius) between the ESS and control groups.
Time Frame
5-6 months
Title
Adverse effects - postoperative synechia formation
Description
Frequency of postoperative synechia formations in the ESS group
Time Frame
5-6 months
Title
Adverse effects - postoperative infection
Description
Frequency of postoperative infections in the ESS group
Time Frame
5-6 months
Title
Adverse effects - postoperative orbital complication
Description
Frequency of postoperative orbital complications in the ESS group
Time Frame
5-6 months
Title
Adverse effects - postoperative intracranial complication
Description
Frequency of postoperative intracranial complications in the ESS group
Time Frame
5-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi M Kaski, MD
Phone
+385442730022
Email
heidi.kaski@student.oulu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olli-Pekka Alho, MD, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi M Kaski, MD
Phone
+384442730022
Email
heidi.kaski@student.oulu.fi
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saara Sillanpää, MD
Phone
+358 3 311 611
Email
saara.sillanpaa@pirha.fi
First Name & Middle Initial & Last Name & Degree
Merja Rumpunen, Ms
Phone
+358 3 311 611
Email
merja.rumpunen@pirha.fi
First Name & Middle Initial & Last Name & Degree
Saara Sillanpää, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34496924
Citation
Kaski HM, Alakarppa A, Lantto U, Laajala A, Tokola P, Penna T, Ohtonen P, Alho OP. Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial. Trials. 2021 Sep 8;22(1):606. doi: 10.1186/s13063-021-05576-z.
Results Reference
derived

Learn more about this trial

Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

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