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Clinical Trials/DRKS00025782
DRKS00025782
Completed
Not Applicable

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

DEGUM0 sites127 target enrollmentJuly 8, 2021
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ConditionsJ33.8Other polyp of sinus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
J33.8
Sponsor
DEGUM
Enrollment
127
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
who.int
Start Date
July 8, 2021
End Date
September 15, 2020
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
DEGUM

Eligibility Criteria

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\.

Outcomes

Primary Outcomes

Not specified

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