Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis

NCT ID: NCT04241016

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2025-05-30

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.

Conditions

Maxillary Sinusitis; Sinusitis, Acute; Sinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic sinus surgery (ESS)

Intervention Type: PROCEDURE

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: collaborator

Oulu University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Olli-Pekka Alho, MD

Professor of Otorhinolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olli-Pekka Alho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

Oulu University Hospital

Oulu, , Finland

Site Status: RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Heidi M Kaski, MD

Role: CONTACT

heidi.kaski@student.oulu.fi

+385442730022

Facility Contacts

Heidi M Kaski, MD

Role: primary

heidi.kaski@student.oulu.fi

+384442730022

Saara Sillanpää, MD

Role: primary

saara.sillanpaa@pirha.fi

+358 3 311 611

Merja Rumpunen, Ms

Role: backup

merja.rumpunen@pirha.fi

+358 3 311 611

References

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.

Reference Type: DERIVED

PMID: 34496924 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

01234

Identifier Type: -

Identifier Source: org_study_id