Chronic RhinosinusitisNCT01255566
Medical Therapy Versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multi-institutional Study
An observational study of Chronic Rhinosinusitis and Sinusitis, run by Oregon Health and Science University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis, Sinusitis
- How many people
- 186 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2009to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects (> 18 years) were prospectively enrolled from four tertiary rhinology practices including Oregon Health \& Science University (OHSU); Northwestern University (NWU); Medical University of South Carolina (MUSC); and the University of Pennsylvania (UPenn). All patients were diagnosed with chronic rhinosinusitis (CRS) as defined by the 2007 Adult Sinusitis Guidelines.
Who may be able to join
- Adults (>= 18 years old)
- Diagnosed with chronic rhinosinusitis
- Failed medical management to date
- Self-selected either sinus surgery or continued medical therapy as next treatment option
- Able to complete surveys in English
Who cannot join
- Unable to complete surveys in English
- Children (< 18 years old)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Comparison of Medical Therapy to Medical Therapy Plus Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
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.
Read the detailed description
Chronic rhinosinusitis (CRS) is a common health condition in the United States resulting in more than 500,000 surgical procedures annually. Since CRS is a disease process that is known to adversely affect quality of life, it is important to understand the short-term and long-term implications of different treatment options as documented by our patients' perception of their quality of life.
- Conditions
- Chronic Rhinosinusitis, Sinusitis
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy cohort | For patients electing continued medical therapy, medication was prescribed based on the disease process and the judgment of the treating rhinologist. Treatment was not specifically dictated or prescribed by the study protocol. | |
| Surgical cohort | For patients electing ESS, surgery was performed by the enrolling rhinologist. In addition, medical management was administered in the perioperative and postoperative periods as dictated by the disease process and the judgment of the treating rhinologist. Treatment was not specifically dictated or prescribed by the study protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhinosinusitis Disability Index and Chronic Sinusitis Survey
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.
Measured: Change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startAug 2009
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, Northwestern University, University of Pennsylvania
- Responsible party
- Principal investigator, Dr. Timothy L. Smith, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255566
- Sponsor's protocol ID
- unfunded
- Status last verified
- Apr 2013
- First submitted
- 6 Dec 2010
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith TL, Kern R, Palmer JN, Schlosser R, Chandra RK, Chiu AG, Conley D, Mace JC, Fu RF, Stankiewicz J. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study with 1-year follow-up. Int Forum Allergy Rhinol. 2013 Jan;3(1):4-9. doi: 10.1002/alr.21065. Epub 2012 Jun 26.
PubMed 22736422Smith TL, Kern RC, Palmer JN, Schlosser RJ, Chandra RK, Chiu AG, Conley D, Mace JC, Fu RF, Stankiewicz JA. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study. Int Forum Allergy Rhinol. 2011 Jul-Aug;1(4):235-41. doi: 10.1002/alr.20063. Epub 2011 Jun 6.
PubMed 22287426
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Medical Therapy to Medical Therapy Plus Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT01255566
- Acronym / sponsor ID
- unfunded
- Conditions
- Chronic Rhinosinusitis, Sinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, Northwestern University, University of Pennsylvania
- Study start
- Aug 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Dec 2010 (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.
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.
Detailed description
Chronic rhinosinusitis (CRS) is a common health condition in the United States resulting in more than 500,000 surgical procedures annually. Since CRS is a disease process that is known to adversely affect quality of life, it is important to understand the short-term and long-term implications of different treatment options as documented by our patients' perception of their quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical therapy cohort | – | –For patients electing continued medical therapy, medication was prescribed based on the disease process and the judgment of the treating rhinologist. Treatment was not specifically dictated or prescribed by the study protocol. |
| Surgical cohort | – | –For patients electing ESS, surgery was performed by the enrolling rhinologist. In addition, medical management was administered in the perioperative and postoperative periods as dictated by the disease process and the judgment of the treating rhinologist. Treatment was not specifically dictated or prescribed by the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects (> 18 years) were prospectively enrolled from four tertiary rhinology practices including Oregon Health \& Science University (OHSU); Northwestern University (NWU); Medical University of South Carolina (MUSC); and the University of Pennsylvania (UPenn). All patients were diagnosed with chronic rhinosinusitis (CRS) as defined by the 2007 Adult Sinusitis Guidelines.
Key inclusion criteria (5 listed)
- Adults (>= 18 years old)
- Diagnosed with chronic rhinosinusitis
- Failed medical management to date
- Self-selected either sinus surgery or continued medical therapy as next treatment option
- Able to complete surveys in English
Key exclusion criteria (2 listed)
- Unable to complete surveys in English
- Children (< 18 years old)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rhinosinusitis Disability Index and Chronic Sinusitis Survey
Time frame: Change from baseline to 12 months
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.
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 24 Apr 2013.
- Derived from this study: PubMed 22736422Smith TL, Kern R, Palmer JN, Schlosser R, Chandra RK, Chiu AG, Conley D, Mace JC, Fu RF, Stankiewicz J. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study with 1-year follow-up. Int Forum Allergy Rhinol. 2013 Jan;3(1):4-9. doi: 10.1002/alr.21065. Epub 2012 Jun 26.
- Derived from this study: PubMed 22287426Smith TL, Kern RC, Palmer JN, Schlosser RJ, Chandra RK, Chiu AG, Conley D, Mace JC, Fu RF, Stankiewicz JA. Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study. Int Forum Allergy Rhinol. 2011 Jul-Aug;1(4):235-41. doi: 10.1002/alr.20063. Epub 2011 Jun 6.
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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.
3 sites 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 and Sinusitis, run by Oregon Health and Science University at 3 sites 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 5 inclusion and 2 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 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Rhinosinusitis Disability Index and Chronic Sinusitis Survey (time frame: Change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01255566, which also lists 2 linked publications.
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 24 Apr 2013.