Chronic RhinosinusitisNCT01943370
Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement
A study testing Early saline irrigation and Routine Irrigation in people with Chronic Rhinosinusitis, run by University of Alberta.
Trial summary
Nasal saline is a common treatment adjunct in the post-operative setting for endoscopic sinus surgery. However, the ideal timing and quantity of irrigation in the early post-operative period remains unknown. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Early saline irrigation and Routine Irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jul 2016
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients
- Diagnosis of CRS with or without polyposis
- Undergoing bilateral endoscopic sinus surgery
- Availability of pre-operative CT paranasal sinuses
Who cannot join
- Patients with diagnosis of:
- Primary ciliary dyskinesia
- Immunodeficiency
- Cystic fibrosis
About this study
Nasal saline is a common treatment adjunct in the post-operative setting for endoscopic sinus surgery. However, the ideal timing and quantity of irrigation in the early post-operative period remains unknown. Proposed benefits of early, large volume irrigation include removal and softening of crusts, resulting in improved mucociliary clearance. The potential benefit of early large volume saline irrigation on post-operative day three to ease or reduce the need for early post-operative debridement has not been studied.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Early saline irrigation, Routine Irrigation
- Keywords
- endoscopic sinus surgery, post-operative irrigation, pain, debridement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early saline irrigationOther
Initiation of post-operative saline irrigation earlier during the post-operative course
Routine IrrigationOther
Routine initiation of saline irrigation
| Study group | Role | What they receive |
|---|---|---|
| Early saline irrigation | Experimental | Initiation of early saline irrigation Receives: Other: Early saline irrigation |
| Late or Routine Saline Irrigation | Active comparator | Routine initiation of saline irrigation Receives: Other: Early saline irrigation; Other: Routine Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain and discomfort during early post-operative debridement on post-operative day 10
Measured: Early post-operative (Day 10)
Secondary outcomes (2)
Endoscopic appearance
Early post-operative POSE score on post-operative day 10
Measured: Early (post-operative day 10)
Late endoscopic appearance at 6 months
Late post-operative endoscopic POSE score at 6 months
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 posted17 Sep 2013 (estimated)
- Study startMay 2015
- Primary completionMay 2016
- Study completionJul 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Xu, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943370
- Sponsor's protocol ID
- ESESS-001
- Other IDs
- Pro00042764
- Status last verified
- Oct 2018
- First submitted
- 6 Sep 2013
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement
- ClinicalTrials.gov ID
- NCT01943370
- Acronym / sponsor ID
- ESESS-001
- Conditions
- Chronic Rhinosinusitis
- Keywords
- endoscopic sinus surgery, post-operative irrigation, pain, debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Sep 2013 (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.
Nasal saline is a common treatment adjunct in the post-operative setting for endoscopic sinus surgery. However, the ideal timing and quantity of irrigation in the early post-operative period remains unknown. Proposed benefits of early, large volume irrigation include removal and softening of crusts, resulting in improved mucociliary clearance. The potential benefit of early large volume saline irrigation on post-operative day three to ease or reduce the need for early post-operative debridement has not been studied.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early saline irrigation | Experimental | Other: Early saline irrigationInitiation of early saline irrigation |
| Late or Routine Saline Irrigation | Active comparator | Other: Early saline irrigation, Other: Routine IrrigationRoutine initiation of saline irrigation |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients
- Diagnosis of CRS with or without polyposis
- Undergoing bilateral endoscopic sinus surgery
- Availability of pre-operative CT paranasal sinuses
Key exclusion criteria (4 listed)
- Primary ciliary dyskinesia
- Immunodeficiency
- 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 |
|---|---|---|
| Early saline irrigationInitiation of post-operative saline irrigation earlier during the post-operative course | Other | Early saline irrigation, Late or Routine Saline Irrigation |
| Routine IrrigationRoutine initiation of saline irrigation | Other | Late or Routine Saline Irrigation |
Primary outcome
Pain
Time frame: Early post-operative (Day 10)
Pain and discomfort during early post-operative debridement on post-operative day 10
2 secondary outcomes
Endoscopic appearance
Time frame: Early (post-operative day 10)
Late endoscopic appearance at 6 months
Time frame: 6 months
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 15 Oct 2018.
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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 Early saline irrigation and Routine Irrigation in people with Chronic Rhinosinusitis, run by University of Alberta.
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 4 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 15 Oct 2018. 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?
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?
Pain (time frame: Early post-operative (Day 10)). 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 15 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.