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NCT01499719 Clinical Trial

Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery

Chronic Rhinosinusitis Clinical Trial

Official title:
Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01499719
Other study ID # checklist pause
Secondary ID
Status Completed
Phase N/A
First received December 21, 2011
Last updated March 28, 2016
Start date December 2011
Est. completion date December 2012

Study information
Verified date March 2016
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this clinical trial is to evaluate the effectiveness of a new surgical checklist in the setting of sinus surgery for patients with chronic rhinosinusitis (CRS) and to measure the frequency of compliance by surgical personnel at OHSU with specific daily safety protocols before and after introduction of the checklist. The investigators hypothesized that the use of an ESS specific surgical checklist will improve the frequency of compliance by surgical personnel at OHSU to internal safety concerns and protocols.

Description:

A total of 200 unidentified, non-randomized endoscopic sinus surgery cases will be observed and reviewed by research personnel (T.L.S, J.C.) within the Oregon Sinus Center, located within the Center for Health and Healing on the South Waterfront Campus of OHSU, under the direction of Timothy L. Smith, MD, MPH (PI). The first 100 surgical cases will be evaluated as "pre-intervention" cases by research personnel while the second 100 surgical cases will be evaluated as "post-intervention" cases after the introduction and discussion of the surgical checklist to operating room staff.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- CRS defined by 2007 Adult Sinusitis Guidelines.13

- Unidentified adult patients electing endoscopic sinus surgery for the treatment of CRS.

Exclusion Criteria:

- Unable to complete surgical procedures due to perioperative complications.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Behavioral:
• Checklist introduction / Pause
Operating room staff will be introduced to a new checklist specifically designed to address concerns around protocols for endoscopic sinus surgery to raise awareness and attention to 11 specific areas of interest.

Locations
Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sinus surgery checklist 11 dichotomous questions regarding observed operating room protocols for internal process improvement. 6 months No
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