Chronic RhinosinusitisNCT02154555
A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery
A study testing debridement in people with Chronic Rhinosinusitis, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Chronic rhinosinusitis (CRS) is a common sinus and nasal condition affecting more than 33 million Americans. The treatment of CRS typically begins with maximal medical therapy however, when this fails to improve patient symptoms, surgical intervention is considered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to 31 Dec 2018
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosed with Chronic Rhinosinusitis (as defined by the American Academy of Otolaryngology - Head \& Neck Surgery)
- Consented to proceed with bilateral ESS
- Require bilateral middle meatus spacers postoperatively
- Adequate fluency in English to provide consent and complete surveys
Who cannot join
- History of immune deficiency
- Allergic fungal sinusitis
- Cystic Fibrosis
Trial locations and contacts
1 site in 1 country.
About this study
Chronic rhinosinusitis (CRS) is a common sinus and nasal condition affecting more than 33 million Americans. The treatment of CRS typically begins with maximal medical therapy however, when this fails to improve patient symptoms, surgical intervention is considered. Endoscopic sinus surgery (ESS) is a well-established treatment for refractory CRS with approximately 600,000 sinus surgeries performed annually in the United States alone. Despite the success of this intervention, up to 26% of patients experience complications following surgery, including middle meatal (MM) synechiae, edema, polyp recurrence, and middle turbinate lateralization. Currently, there is no consensus as to the postoperative care regime that is most effective at minimizing or preventing these potential complications. Therefore there is need for further study into the role of debridement, examining patients undergoing endoscopic sinus surgery while concurrently addressing the potential confounders of maximal medical therapies in the postoperative setting.
This prospective, randomized, single-blind, controlled study design will investigate the efficacy of postoperative debridement following ESS. Patients who have undergone ESS will have one nare randomized to debridement and the other to no debridement at the first week post-operative visit. In this way, the patients will act as their own controls in order to account for inter-patient variability in disease severity. The primary outcome will assess synechiae formation attributed to ESS. Secondary outcomes will include pain (side-specific) attributed to the debridement procedure as well as comparing pre and post endoscopy scores and SNOT-22 questionnaire responses.
Read the detailed description
The significant heterogeneity present in the current literature regarding the use of postoperative debridement warrants additional studies that document postoperative protocols and use universally accepted endoscopy scores in order to consistently track patient outcomes. Further investigation into the efficacy of postoperative debridement is especially interesting with the potential benefits of further reduced synechiae formation and edema. Conversely, if objective evidence fails to demonstrate benefit of postoperative debridement, there could be significant cost and time saving for healthcare professionals in removing this therapy from the postoperative protocols.
We hypothesize that postoperative debridement will have a significant effect on reducing the rates of synechiae formation. In addition, we hypothesize that this improvement in synechiae development will also be matched by improvements in postoperative endoscopic sinus scoring, and patient's overall symptoms at 1 and 3 months postoperatively.
This study can clarify the efficacy of postoperative debridement and the potential benefits of further reduced synechiae formation and edema, and thus decrease the rates of complication and revision surgery. Conversely, if objective evidence fails to demonstrate benefit of postoperative debridement, there could be significant cost and time saving for healthcare professionals in removing this therapy from the postoperative protocols.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
debridementProcedure or surgery
post-operative debridement at 1 week follow-up visit
| Study group | Role | What they receive |
|---|---|---|
| no debridement | No intervention | The postoperative clinical visits will occur at one week, one month, and three months following surgery. During all three postoperative visits, no debridement will be performed. |
| debridement | Experimental | The postoperative clinical visits will occur at one week, one month, and three months following surgery. During the one week postoperative visit, the randomized unilateral debridement will be performed. Debridement includes removing any crust or mucous in the nose. During the one month and three month visit, the PI will only examine the nose. Receives: Procedure: debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of synechiae - binary rating
adhesions, scarring between middle turbinate and lateral nasal wall
Measured: 1 week, 1 month, and 3 months after surgery
Secondary outcomes (12)
Change of Lund-Kennedy endoscopy score
Measured: before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
Change of pain score - 10-point Likert scale
rated for each sinonasal cavity
Measured: 1 week after surgery
Change of SNOT-22 score
22-item sinonasal outcome test (SNOT-22) questionnaire score
Measured: before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
10-point Likert scale
rated for each sinonasal cavity
Measured: 1 month after surgery
pain score - 10-point Likert scale
rated for each sinonasal cavity
Measured: 3 months after surgery
Lund-Kennedy endoscopy score
Measured: 1 week after surgery
Lund-Kennedy endoscopy score
Measured: 1 month after surgery
Lund-Kennedy endoscopy score
Measured: 3 months after surgery
SNOT-22 score
22-item sinonasal outcome test (SNOT-22) questionnaire score
Measured: 1 week after surgery
SNOT-22 score
22-item sinonasal outcome test (SNOT-22) questionnaire score
Measured: 1 month after surgery
SNOT-22 score
22-item sinonasal outcome test (SNOT-22) questionnaire score
Measured: 3 months after surgery
pain score - 10-point Likert scale
rated for each sinonasal cavity
Measured: before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2017
- Study completion31 Dec 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Lee, MD, FRCSC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154555
- Sponsor's protocol ID
- POD_001
- Status last verified
- Feb 2019
- First submitted
- 25 Apr 2014
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT02154555
- Acronym / sponsor ID
- POD_001
- Conditions
- Chronic Rhinosinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 3 Jun 2014 (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.
Chronic rhinosinusitis (CRS) is a common sinus and nasal condition affecting more than 33 million Americans. The treatment of CRS typically begins with maximal medical therapy however, when this fails to improve patient symptoms, surgical intervention is considered. Endoscopic sinus surgery (ESS) is a well-established treatment for refractory CRS with approximately 600,000 sinus surgeries performed annually in the United States alone. Despite the success of this intervention, up to 26% of patients experience complications following surgery, including middle meatal (MM) synechiae, edema, polyp recurrence, and middle turbinate lateralization. Currently, there is no consensus as to the postoperative care regime that is most effective at minimizing or preventing these potential complications. Therefore there is need for further study into the role of debridement, examining patients undergoing endoscopic sinus surgery while concurrently addressing the potential confounders of maximal medical therapies in the postoperative setting.
This prospective, randomized, single-blind, controlled study design will investigate the efficacy of postoperative debridement following ESS. Patients who have undergone ESS will have one nare randomized to debridement and the other to no debridement at the first week post-operative visit. In this way, the patients will act as their own controls in order to account for inter-patient variability in disease severity. The primary outcome will assess synechiae formation attributed to ESS. Secondary outcomes will include pain (side-specific) attributed to the debridement procedure as well as comparing pre and post endoscopy scores and SNOT-22 questionnaire responses.
Detailed description
The significant heterogeneity present in the current literature regarding the use of postoperative debridement warrants additional studies that document postoperative protocols and use universally accepted endoscopy scores in order to consistently track patient outcomes. Further investigation into the efficacy of postoperative debridement is especially interesting with the potential benefits of further reduced synechiae formation and edema. Conversely, if objective evidence fails to demonstrate benefit of postoperative debridement, there could be significant cost and time saving for healthcare professionals in removing this therapy from the postoperative protocols.
We hypothesize that postoperative debridement will have a significant effect on reducing the rates of synechiae formation. In addition, we hypothesize that this improvement in synechiae development will also be matched by improvements in postoperative endoscopic sinus scoring, and patient's overall symptoms at 1 and 3 months postoperatively.
This study can clarify the efficacy of postoperative debridement and the potential benefits of further reduced synechiae formation and edema, and thus decrease the rates of complication and revision surgery. Conversely, if objective evidence fails to demonstrate benefit of postoperative debridement, there could be significant cost and time saving for healthcare professionals in removing this therapy from the postoperative protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no debridement | No intervention | –The postoperative clinical visits will occur at one week, one month, and three months following surgery. During all three postoperative visits, no debridement will be performed. |
| debridement | Experimental | Procedure: debridementThe postoperative clinical visits will occur at one week, one month, and three months following surgery. During the one week postoperative visit, the randomized unilateral debridement will be performed. Debridement includes removing any crust or mucous in the nose. During the one month and three month visit, the PI will only examine the nose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Chronic Rhinosinusitis (as defined by the American Academy of Otolaryngology - Head \& Neck Surgery)
- Consented to proceed with bilateral ESS
- Require bilateral middle meatus spacers postoperatively
- Adequate fluency in English to provide consent and complete surveys
Key exclusion criteria (3 listed)
- History of immune deficiency
- Allergic fungal sinusitis
- Cystic Fibrosis
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 |
|---|---|---|
| debridementpost-operative debridement at 1 week follow-up visit | Procedure or surgery | debridement |
Primary outcome
Change of synechiae - binary rating
Time frame: 1 week, 1 month, and 3 months after surgery
adhesions, scarring between middle turbinate and lateral nasal wall
12 secondary outcomes
Change of Lund-Kennedy endoscopy score
Time frame: before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
Change of pain score - 10-point Likert scale
Time frame: 1 week after surgery
Change of SNOT-22 score
Time frame: before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
10-point Likert scale
Time frame: 1 month after surgery
pain score - 10-point Likert scale
Time frame: 3 months after surgery
Lund-Kennedy endoscopy score
Time frame: 1 week after surgery
Lund-Kennedy endoscopy score
Time frame: 1 month after surgery
Lund-Kennedy endoscopy score
Time frame: 3 months after surgery
SNOT-22 score
Time frame: 1 week after surgery
SNOT-22 score
Time frame: 1 month after surgery
SNOT-22 score
Time frame: 3 months after surgery
pain score - 10-point Likert scale
Time frame: before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
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 6 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Rhinosinusitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
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.
John Lee, MD, FRCSC principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing debridement in people with Chronic Rhinosinusitis, run by Unity Health Toronto at 1 site in Canada.
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 4 inclusion and 3 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 6 Feb 2019. 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 Canada. 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?
Change of synechiae - binary rating (time frame: 1 week, 1 month, and 3 months after surgery). 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 6 Feb 2019.