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Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children

NCT03336671 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-10-13

No results posted yet for this study

Summary

The objectives of this study would be to determine the most effective management for pediatric patients with chronic rhinosinusitis and asthma who fail medical management. The Sinus and Nasal Quality of Life Survey (SN-5), a validated tool, will be used to track symptoms of pediatric chronic rhinosinusitis. A decrease in at least 0.5 is felt to represent an improvement in symptom control. In this study, the SN-5 at one year post intervention will be the primary endpoint. Secondary endpoints include complications, revision surgery, and post operative endoscopy scores.

Conditions

  • Chronic Sinusitis
  • Adenoid Disease - Chronic

Interventions

PROCEDURE

Endoscopic Sinus surgery

Endoscopic sinus surgery would be tailored to abnormal findings in the CT scan, as is the standard of care. Radiologists typically examine sinonasal disease of the sinuses, and they would also be requested to comment on the patency of the osteo-meatal unit, as this is a component of the Lund-McKay score. The Lund-McKay score is an objective radiologic grade of the severity of sinusitis. If there is sinus thickening, or narrowing of the OMU, endoscopic sinus surgery would be tailored to this using either balloon sinuplasty or traditional antrostomy. Patient undergoing endoscopic sinus surgery will likely have at least a maxillary antrostomy and anterior ethmoidectomy performed, with frontal sinusotomy, posterior ethmoidectomy, and sphenoidotomy performed depending on CT or endoscopy findings.

PROCEDURE

Adenoidectomy

Adenoidectomy performed, routine, as a singular procedure not combined with any sinus surgery.

Sponsors & Collaborators

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • Haidy Marzouk, MD · State University of New York - Upstate Medical University

  • Mark Arnold, MD · 315 464-4678

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2020-07-01
Completion
2020-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336671 on ClinicalTrials.gov