Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

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: Recruiting
• Conditions: Sinusitis; Maxillary Sinusitis; Sinusitis, Acute
• Intervention / Treatment: Procedure: Endoscopic sinus surgery (ESS)

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: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi M Kaski, MD; Phone Number: +385442730022; Email: heidi.kaski@student.oulu.fi

Study Locations

• Finland
  • Oulu, Finland
    • Recruiting
    • Oulu University Hospital
    • Contact: Heidi M Kaski, MD; Phone Number: +384442730022; Email: heidi.kaski@student.oulu.fi
  • Tampere, Finland
    • Recruiting
    • Tampere university Hospital
    • Contact: Saara Sillanpää, MD; Phone Number: +358 3 311 611; Email: saara.sillanpaa@pirha.fi
    • Contact: Merja Rumpunen, Ms; Phone Number: +358 3 311 611; Email: merja.rumpunen@pirha.fi
    • Principal Investigator: Saara Sillanpää, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	5-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5-6 months
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)	5-6 months
Difference in numbers of sinusitis episodes	Difference in the numbers of sinusitis episodes between the ESS and control groups.	5-6 months
Difference in numbers of medical visits	Difference in the numbers of medical visits between the ESS and control groups.	5-6 months
Difference in numbers of antimicrobial treatments	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	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	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	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	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	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	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	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	Frequency of postoperative synechia formations in the ESS group	5-6 months
Adverse effects - postoperative infection	Frequency of postoperative infections in the ESS group	5-6 months
Adverse effects - postoperative orbital complication	Frequency of postoperative orbital complications in the ESS group	5-6 months
Adverse effects - postoperative intracranial complication	Frequency of postoperative intracranial complications in the ESS group	5-6 months

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: Tampere University Hospital
• Investigators: Principal Investigator: Olli-Pekka Alho, MD, PhD, Oulu University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: adult; endoscopic sinus surgery
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Maxillary Sinusitis
• Other Study ID 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