NCT01499719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

December 21, 2011

Last Update Submit

March 28, 2016

Conditions

Keywords

SinusitisDiseaseChronicSinonasal

Outcome Measures

Primary Outcomes (1)

  • Sinus surgery checklist

    11 dichotomous questions regarding observed operating room protocols for internal process improvement.

    6 months

Study Arms (1)

Surgical checklist

Compliance for surgical checklist

Behavioral: Checklist introduction / Pause

Interventions

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.

Surgical checklist

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Resident and fellow surgeons.

You may qualify if:

  • CRS defined by 2007 Adult Sinusitis Guidelines.13
  • Unidentified adult patients electing endoscopic sinus surgery for the treatment of CRS.

You may not qualify if:

  • Unable to complete surgical procedures due to perioperative complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

SinusitisDiseaseBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 26, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations