Chronic Rhinosinusitis (Diagnosis)NCT06502197
Comparative Analysis of Silastic Stenting in Sinus Surgery
A study testing Silastic Stenting in people with Chronic Rhinosinusitis (Diagnosis), run by University of British Columbia.
Trial summary
Silastic stenting is a measure taken to support tissue healing following sinus surgery. Silastic stents are inserted into the sinus cavities and provide structural support while facilitating healing in the critical period of recovery following surgery. Read more about this study
- Who is it for?
- Ages 19 to 89 years
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Silastic Stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2024to 2 Mar 2026
- 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 19 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with chronic rhinosinusitis requiring Frontal drill-out.
Who cannot join
- Patients unwilling or unable to comply with the study protocol.
- Previous Radiotherapy to operated area.
About this study
Official title: Comparative Analysis of Short-term (4 Weeks) vs. Long-term (12 Weeks) Silastic Stenting in Frontal Sinus Surgery: A Prospective Study of Clinical Outcomes
Silastic stenting is a measure taken to support tissue healing following sinus surgery. Silastic stents are inserted into the sinus cavities and provide structural support while facilitating healing in the critical period of recovery following surgery. There is controversy over the optimal duration for which silastic stents should be left in place. Having them in place for shorter periods may reduce the likelihood of stent-related reactions, while leaving them for longer periods could promote more tissue healing. The aim of this study is to compare the impact of stent duration on clinical outcomes of patients following sinus surgery.
Read the detailed description
Patients will be recruited consecutively from the PI's frontal sinus surgery list. The research assistant will approach the patient to obtain informed consent before the day of the operation. A written patient information leaflet explaining the study will be provided.
Eligible patients will be categorized into two groups:
- Group A: Short-term stent retention (4 weeks)
- Group B: Long-term stent retention (12 weeks) We aim for a sequence of 50 "4 week-stent" and 50 "12 week-stent". The patients will be told whether they are receiving the stent for 4 or 12 weeks at the day of surgery.
Standard of care:
- Preoperative visit, assessment including nasal endoscopy and completion of SNOT-22 baseline questionnaire.
- Surgery with frontal sinus drill out (Draf IIa, IIb, \&III) are done as a standard of care in these centers. Dressing of the raw drilled out surface area of the beak with silastic stents is the standard of care for all drill outs.
- Post-operative follow-ups at 4 weeks and 12 weeks', with 4 weeks vs 12 weeks of stent removal time scale.
Study will require:
- Categorization of patients into two groups: one group who will have a silastic stent for 4 weeks, and the other group will have stent in place for 12 weeks.
- Saving a copy of the endoscopic image intra-operative and at 6 months and one-year post-op. To compare the size of a frontal drainage pathway, measuring anterior-posterior \& medial-lateral diameters.
Study Process:
At the first pre-operative appointment for drill out, the procedure is discussed. At this point, the study will be introduced by the principal and sub investigators and explained in detail by the research coordinator who would also obtain informed consent. If the patient consents to the study, a SNOT22 (sino-nasal outcome measure 22) pre-operative questionnaire will be completed; thereafter, they will be categorized to one of the two groups.
At time of surgery, frontal stent placement is placed to minimize contracture and to aid with re-mucolisation of the raw surface area due to the drill out, allowing for creation of optimal frontal sinus opening. Therefore, after the maximal desired sinus drill out has been achieved, and the surgeon feels that the surgery proceeded routinely, with no circumstances that would indicate the use of silastic stents for other reasons (such as injury to posterior plate mucosa or 360 mucosal disruption), an envelope that indicates which arm of the study the patient will be opened and the choice for placement of the stent for what time interval would be revealed to the surgeon. In the event of a non-routine surgery, the surgeon will complete the surgery as required by the circumstance, and the patient will be withdrawn from the study. The information about withdrawal will be communicated to the participant immediately post-operative, and during their first routine follow-up appointment.
For all participants that provide informed consent, a routine follow-up endoscopic assessment will be performed as per standard of care at 4 weeks, 12 weeks, 6 months and 1 year. During these examinations an endonasal photograph will be taken for measurement and analyzing. Photographs will be evaluated by two independent surgeons to reduce bias.
At the second and final 1-year postoperative follow-ups, the patients will be asked to complete two brief questionnaires of the patient-reported experience related to healing. Questionnaires on symptoms: one is the validated SNOT22 scoring system and the other was adopted from SNOT22; both address health related issues concerning the quality of life as pertain to sinus disease1. The second questionnaire includes the following items that relate to the study aims:
- During the post-operative process:
- Nasal obstruction (none-mild-moderate-severe)
- Crusting (none-mild-moderate-severe)
- Cacosmia (none-mild-moderate-severe)
- Halitosis (none-mild-moderate-severe)
- Nasal discomfort (none-mild-moderate-severe)
- Acute sinus infection (when, duration, antibiotic requirement).
- Experience of the post-operative appointment:
- Pain association with debridement and/or stent removal [graded on a visual analogue scale where 0 is no pain (none) and 10 is the worst (severe) pain ever experienced]
- Did the patients adhere to taken analgesia (Tylenol / Paracetamol) 30 mins pre-procedure.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Silastic Stenting
- Keywords
- Chronic Rhinosinusitis, Endoscopic Sinus Surgery, Silastic Stenting
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silastic StentingProcedure or surgery
Drill-out frontal sinus procedures, are a well-established surgical intervention in the management of CRS, involves extensive sinus surgery with the creation of a large, surgically exposed area of raw bone. This raw bone, left exposed postoperatively, poses a unique challenge in the context of mucosal healing. Silastic stents, inserted into the sinus cavities, offer a promising solution by providing structural support and facilitating mucosal re-mucolisation in this critical period of postoperative recovery.
| Study group | Role | What they receive |
|---|---|---|
| Short-term (4 weeks) Silastic Stenting | Experimental | Not described Receives: Procedure: Silastic Stenting |
| Long-term (12 weeks) Silastic Stenting | Experimental | Not described Receives: Procedure: Silastic Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-Term Patency
Patency is to be assessed by using the validated scoring system from Lund VJ, Kennedy DW. Quantification for staging sinusitis. In: Kennedy DW, editor. International Conference on Sinus Disease: Terminology, Staging, Therapy. Ann Otol Rhinol Laryngol 1995; 104(Suppl 167):17-21.
Measured: 6 and 18 months
Incidence of acute sinus infection
The occurrence and frequency of acute sinusitis in both cohorts, requiring rescue course of oral antibiotics.
Measured: 2 and 4 weeks
Secondary outcomes (2)
Tolerability Assessment
Instrument: Likert Scale
Measured: At the respective stent extraction time
Symptom Relief Assessment
Instrument: Sinonasal Outcome Test-22 (SNOT-22)
Measured: 6 and 18 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start2 Sep 2024 (estimated)
- Primary completion2 Sep 2025 (estimated)
- Study completion2 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Addenbrooke's Hospital, Cambridge University, NHS Greater Glasgow and Clyde
- Responsible party
- Principal investigator, Arif Janjua, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502197
- Sponsor's protocol ID
- H23-03592
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Short-term (4 Weeks) vs. Long-term (12 Weeks) Silastic Stenting in Frontal Sinus Surgery: A Prospective Study of Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06502197
- Acronym / sponsor ID
- H23-03592
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- Chronic Rhinosinusitis, Endoscopic Sinus Surgery, Silastic Stenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Addenbrooke's Hospital, Cambridge University, NHS Greater Glasgow and Clyde
- Study start
- 2 Sep 2024 (estimated)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 2 Mar 2026 (estimated)
- First posted
- 16 Jul 2024 (actual)
- 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.
Silastic stenting is a measure taken to support tissue healing following sinus surgery. Silastic stents are inserted into the sinus cavities and provide structural support while facilitating healing in the critical period of recovery following surgery. There is controversy over the optimal duration for which silastic stents should be left in place. Having them in place for shorter periods may reduce the likelihood of stent-related reactions, while leaving them for longer periods could promote more tissue healing. The aim of this study is to compare the impact of stent duration on clinical outcomes of patients following sinus surgery.
Detailed description
Patients will be recruited consecutively from the PI's frontal sinus surgery list. The research assistant will approach the patient to obtain informed consent before the day of the operation. A written patient information leaflet explaining the study will be provided.
Eligible patients will be categorized into two groups:
- Group A: Short-term stent retention (4 weeks)
- Group B: Long-term stent retention (12 weeks) We aim for a sequence of 50 "4 week-stent" and 50 "12 week-stent". The patients will be told whether they are receiving the stent for 4 or 12 weeks at the day of surgery.
Standard of care:
- Preoperative visit, assessment including nasal endoscopy and completion of SNOT-22 baseline questionnaire.
- Surgery with frontal sinus drill out (Draf IIa, IIb, \&III) are done as a standard of care in these centers. Dressing of the raw drilled out surface area of the beak with silastic stents is the standard of care for all drill outs.
- Post-operative follow-ups at 4 weeks and 12 weeks', with 4 weeks vs 12 weeks of stent removal time scale.
Study will require:
- Categorization of patients into two groups: one group who will have a silastic stent for 4 weeks, and the other group will have stent in place for 12 weeks.
- Saving a copy of the endoscopic image intra-operative and at 6 months and one-year post-op. To compare the size of a frontal drainage pathway, measuring anterior-posterior \& medial-lateral diameters.
Study Process:
At the first pre-operative appointment for drill out, the procedure is discussed. At this point, the study will be introduced by the principal and sub investigators and explained in detail by the research coordinator who would also obtain informed consent. If the patient consents to the study, a SNOT22 (sino-nasal outcome measure 22) pre-operative questionnaire will be completed; thereafter, they will be categorized to one of the two groups.
At time of surgery, frontal stent placement is placed to minimize contracture and to aid with re-mucolisation of the raw surface area due to the drill out, allowing for creation of optimal frontal sinus opening. Therefore, after the maximal desired sinus drill out has been achieved, and the surgeon feels that the surgery proceeded routinely, with no circumstances that would indicate the use of silastic stents for other reasons (such as injury to posterior plate mucosa or 360 mucosal disruption), an envelope that indicates which arm of the study the patient will be opened and the choice for placement of the stent for what time interval would be revealed to the surgeon. In the event of a non-routine surgery, the surgeon will complete the surgery as required by the circumstance, and the patient will be withdrawn from the study. The information about withdrawal will be communicated to the participant immediately post-operative, and during their first routine follow-up appointment.
For all participants that provide informed consent, a routine follow-up endoscopic assessment will be performed as per standard of care at 4 weeks, 12 weeks, 6 months and 1 year. During these examinations an endonasal photograph will be taken for measurement and analyzing. Photographs will be evaluated by two independent surgeons to reduce bias.
At the second and final 1-year postoperative follow-ups, the patients will be asked to complete two brief questionnaires of the patient-reported experience related to healing. Questionnaires on symptoms: one is the validated SNOT22 scoring system and the other was adopted from SNOT22; both address health related issues concerning the quality of life as pertain to sinus disease1. The second questionnaire includes the following items that relate to the study aims:
- During the post-operative process:
- Nasal obstruction (none-mild-moderate-severe)
- Crusting (none-mild-moderate-severe)
- Cacosmia (none-mild-moderate-severe)
- Halitosis (none-mild-moderate-severe)
- Nasal discomfort (none-mild-moderate-severe)
- Acute sinus infection (when, duration, antibiotic requirement).
- Experience of the post-operative appointment:
- Pain association with debridement and/or stent removal [graded on a visual analogue scale where 0 is no pain (none) and 10 is the worst (severe) pain ever experienced]
- Did the patients adhere to taken analgesia (Tylenol / Paracetamol) 30 mins pre-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-term (4 weeks) Silastic Stenting | Experimental | Procedure: Silastic Stenting |
| Long-term (12 weeks) Silastic Stenting | Experimental | Procedure: Silastic Stenting |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with chronic rhinosinusitis requiring Frontal drill-out.
Key exclusion criteria (2 listed)
- Patients unwilling or unable to comply with the study protocol.
- Previous Radiotherapy to operated area.
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 |
|---|---|---|
| Silastic StentingDrill-out frontal sinus procedures, are a well-established surgical intervention in the management of CRS, involves extensive sinus surgery with the creation of a large, surgically exposed area of raw bone. This raw bone, left exposed postoperatively, poses a unique challenge in the context of mucosal healing. Silastic stents, inserted into the sinus cavities, offer a promising solution by providing structural support and facilitating mucosal re-mucolisation in this critical period of postoperative recovery. | Procedure or surgery | Long-term (12 weeks) Silastic Stenting, Short-term (4 weeks) Silastic Stenting |
Primary outcome
Long-Term Patency
Time frame: 6 and 18 months
Patency is to be assessed by using the validated scoring system from Lund VJ, Kennedy DW. Quantification for staging sinusitis. In: Kennedy DW, editor. International Conference on Sinus Disease: Terminology, Staging, Therapy. Ann Otol Rhinol Laryngol 1995; 104(Suppl 167):17-21.
Incidence of acute sinus infection
Time frame: 2 and 4 weeks
The occurrence and frequency of acute sinusitis in both cohorts, requiring rescue course of oral antibiotics.
2 secondary outcomes
Tolerability Assessment
Time frame: At the respective stent extraction time
Symptom Relief Assessment
Time frame: 6 and 18 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Silastic Stenting in people with Chronic Rhinosinusitis (Diagnosis), run by University of British Columbia.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Long-Term Patency (time frame: 6 and 18 months). The study lists 2 primary outcomes in all. 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 16 Jul 2024.