Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery

Completed

• Conditions: Chronic Rhinosinusitis
• Interventions: Behavioral: Checklist introduction / Pause

• Registration Number: NCT01499719
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical checklist	Checklist introduction / Pause	Compliance for surgical checklist

Primary Outcome Measures

Name	Time	Method
Sinus surgery checklist	6 months	11 dichotomous questions regarding observed operating room protocols for internal process improvement.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States