Chronic RhinosinusitisNCT01499719
Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery
An observational study of Chronic Rhinosinusitis, run by Oregon Health and Science University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Checklist introduction / Pause
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Resident and fellow surgeons.
Who may be able to join
- CRS defined by 2007 Adult Sinusitis Guidelines.13
- Unidentified adult patients electing endoscopic sinus surgery for the treatment of CRS.
Who cannot join
- Unable to complete surgical procedures due to perioperative complications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Checklist introduction / Pause
- Keywords
- Sinusitis, Disease, Chronic, Sinonasal
- Medical subject headings
- Sinusitis, Disease, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checklist introduction / PauseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical checklist | Compliance for surgical checklist Receives: Behavioral: Checklist introduction / Pause |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus surgery checklist
11 dichotomous questions regarding observed operating room protocols for internal process improvement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Timothy L. Smith, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499719
- Sponsor's protocol ID
- checklist pause
- Status last verified
- Mar 2016
- First submitted
- 21 Dec 2011
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT01499719
- Acronym / sponsor ID
- checklist pause
- Conditions
- Chronic Rhinosinusitis
- Keywords
- Sinusitis, Disease, Chronic, Sinonasal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical checklist | – | Behavioral: Checklist introduction / PauseCompliance for surgical checklist |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Resident and fellow surgeons.
Key inclusion criteria (2 listed)
- CRS defined by 2007 Adult Sinusitis Guidelines.13
- Unidentified adult patients electing endoscopic sinus surgery for the treatment of CRS.
Key exclusion criteria (1 listed)
- Unable to complete surgical procedures due to perioperative complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Checklist introduction / PauseOperating 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. | Behavioural | Surgical checklist |
Primary outcome
Sinus surgery checklist
Time frame: 6 months
11 dichotomous questions regarding observed operating room protocols for internal process improvement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinus surgery checklist (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.