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Completed

NCT Number: NCT00871286

Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study

The purpose of this research study is to determine whether or not computed tomography (CT) scans performed on patients with symptoms of chronic rhinosinusitis (CRS) but without any physical signs of the disease will (1) prove to be less expensive in the treatment and evaluation as compared to current practices, (2) avoid the use of unnecessary antibiotic prescriptions, and (3) provide a more efficient way to diagnose conditions in patients who have had CRS ruled out as a cause.

The investigators hypothesize that current guidelines, when applied to subjects with symptoms of CRS in the absence of physical signs may be associated with (1) increased unnecessary prescription of antibiotics, (2) delay in further essential workup, and (3) increased overall health care costs.

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Key information

Conditions

Chronic Rhinosinusitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University/Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects actively meeting the symptomatic criteria for CRS as defined by the Taskforce on Rhinosinusitis but with physical and endoscopic examination that is within normal limits

Exclusion criteria

  • Subjects who are pregnant
  • Subjects with a diagnosis of immune suppression or suspicion of malignancy that may be affecting the nose/paranasal sinuses
  • Subjects who have had prior sinus surgery or who have been previously treated with a >3 week course of broad spectrum antibiotics for CRS

Treatment and study plan

Pre-treatment Sinus CT Scan

Procedure

Pre-treatment Sinus CT Scan

Post-treatment Sinus CT Scan

Procedure

Post-treatment Sinus CT Scan

Primary outcomes

  1. Number of Participants in Compliance With Medical Recommendations

    Time frame: 8 weeks

    Number of participants in each group who complied with medical advice given at the initial appointment.

  2. Number of Participants Having a CT Done

    Time frame: 8 weeks

    Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Role of Point-of-Care CT Scanning in Patients Presenting With Symptoms of Chronic Rhinosinusitis

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2009
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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