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NCT01255566 · ClinicalTrials.gov registry record

Medical Therapy Versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multi-institutional Study

A clinical trial, sponsored by Oregon Health and Science University.

Completed
Registry status
186
Enrollment target

NCT01255566: Completed study, sponsored by Oregon Health and Science University.

NCT01255566 is a clinical trial that has completed, run by Oregon Health and Science University. The registered enrollment target is 186 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01255566 has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
186 participants
Enrollment target

Study Summary

This investigation is a prospective, multi-institutional cohort study comparing the differences in health-related quality-of-life (HRQoL) improvements between subjects electing continued medical management for chronic rhinosinusitis and those electing medical management plus surgical intervention. Our hypothesis is 3 fold: 1. That patients electing continued medical management will have less disease severity as measured by CT and baseline HRQoL scores, 2. Patients undergoing medical management plus ESS for chronic rhinosinusitis will experience a larger improvement in health related quality of life (HRQoL)compared to patients electing medical management alone, and 3. Patients undergoing medical management plus ESS for chronic rhinosinusitis will use fewer antibiotics, systemic steroids, and miss fewer days of work/school compared to patients electing medical management alone.

Primary Outcome

The RSDI is a validated, disease-specific quality-of-life survey designed for patients with sinonasal disease. The RSDI has three separate subscales incorporating 30 questions with a total score range of 0-120. The CSS is a validated, 6 question survey with two separate subscales which measure the impact of sinonasal symptoms and medication use in the preceding 8-week period. Total score range of 0-100 for total and subscale measures.

Trial Details

FieldValue
Enrollment Target 186 participants
Start Date 2009-08
Est. Completion 2012-08

What the finished NCT01255566 record still lists

NCT01255566 is an observational study that tracks outcomes without assigning an intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01255566 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01255566 about?

NCT01255566 is a clinical study titled "Medical Therapy Versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multi-institutional Study". This investigation is a prospective, multi-institutional cohort study comparing the differences in health-related quality-of-life (HRQoL) improvements between subjects electing continued medical management for chronic rhinosinusitis and those electing medical management plus surgical intervention. ...

What is the current status of trial NCT01255566?

This trial is currently completed. The enrollment target is 186 participants. The study started on 2009-08. Estimated completion is 2012-08.

Who is sponsoring clinical trial NCT01255566?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01255566, the US trial registry maintained by the National Library of Medicine. NCT01255566 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.