Multicenter observational study to evaluate the diagnostic value of sonography in patients with chronic Rhinosinusitis

• Conditions: J33.8; Other polyp of sinus

• Registration Number: DRKS00025782
• Lead Sponsor: DEGUM

Brief Summary

We observed high accuracy with CT, confirming its importance in preoperative imaging in CRS. Despite the high US expertise of all investigators and a standardized examination protocol, the validity of CT was significantly higher than US. Ultrasound of the PNS sinuses is applicable in everyday clinical practice but lacks diagnostic accuracy. Nevertheless, it might serve as a complementary hands-on screening tool to directly correlate the clinical findings in patients with PNS disease.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-09-15
• Study Start: 2021-07-08
• Results First Posted: 2022-08-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

To be included in the observational study, the following inclusion criteria were mandatory:
1. patient age over 18 years and patients with chronic maxillary and/or frontal sinusitis who underwent CT of the PNS in anticipation of the need for surgical treatment.
2. B-mode ultrasonography of the PNS as well as CT of the PNS preoperatively within 8 weeks, with continued A-mode ultrasonography if available.
3. No pretreatment with systemic cortisone or antibiotics within 10 days prior to the time of CT and sonography.
4. Optional additional criteria: to be classified as an ideal patient with additional evaluation of intraoperative findings: Surgery no more than two days after CT and US; no systemic antibiotic or corticosteroid treatment between CT/US and surgery. If surgery was omitted or performed later, patients were still included in the entire group of all patients, but no longer in the subgroup of ideal patients.
Participation in the study was voluntary for the patients and based on informed and written consent.

Exclusion Criteria

Patients excluded from the observational study were:
1. under 18 years of age
2. missing informed consent to participate in the observational study.
3. presence of a disease of the PNS other than CRS
4. Absence of one or more of the above parameters 1-4.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Results during surgery and grade of disease<br>Compare sonography and CT<br>Compare CT vs. surgery<br>Compare sonography vs. surgery<br>Compare centers