NCT04241016

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

4.7 years

First QC Date

January 17, 2020

Last Update Submit

May 30, 2023

Conditions

Maxillary SinusitisSinusitis, AcuteSinusitis

Keywords

adultendoscopic sinus surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • 36-Item Short Form Survey (SF-36, RAND) score

    5-6 months

  • Difference in proportions of patients benefiting

    5-6 months

  • Difference in numbers of sinusitis episodes

    5-6 months

  • Difference in numbers of medical visits

    5-6 months

  • Difference in numbers of antimicrobial treatments

    5-6 months

  • +11 more secondary outcomes

Study Arms (2)

Endoscopic sinus surgery (ESS)

ACTIVE COMPARATOR

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)

Control

NO INTERVENTION

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

Interventions

Endoscopic sinus surgery (ESS)PROCEDURE

Uncinectomy, middle meatal antrostomy by enlarging the natural maxillary ostium and partial ethmoidectomy or septoplasty according to clinical evaluation of the operator.

Endoscopic sinus surgery (ESS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oulu University Hospital

Oulu, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34496924DERIVED

MeSH Terms

Conditions

Maxillary SinusitisSinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Olli-Pekka Alho, MD, PhD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi M Kaski, MD

CONTACT

+385442730022heidi.kaski@student.oulu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Otorhinolaryngology

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 27, 2020

Study Start

May 1, 2020

Primary Completion

December 31, 2024

Study Completion

May 30, 2025

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

FI(2)