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Clinical Trials/NCT01943370
NCT01943370CompletedNot Applicable

Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement

University of Alberta0 sites25 target enrollmentStarted: May 1, 2015Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Primary Endpoint
Pain
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Other
Masking
Single (Investigator)

Eligibility Criteria

Ages
17 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult patients
  • •Diagnosis of CRS with or without polyposis
  • •Undergoing bilateral endoscopic sinus surgery
  • •Availability of pre-operative CT paranasal sinuses

Exclusion Criteria

  • •Patients with diagnosis of:
  • •Primary ciliary dyskinesia
  • •Immunodeficiency
  • •Cystic fibrosis

Arms & Interventions

Early saline irrigation

Experimental

Initiation of early saline irrigation

Intervention: Early saline irrigation (Other)

Late or Routine Saline Irrigation

Active Comparator

Routine initiation of saline irrigation

Intervention: Early saline irrigation (Other)

Late or Routine Saline Irrigation

Active Comparator

Routine initiation of saline irrigation

Intervention: Routine Irrigation (Other)

Outcomes

Primary Outcomes

Pain

Time Frame: Early post-operative (Day 10)

Pain and discomfort during early post-operative debridement on post-operative day 10

Secondary Outcomes

  • Endoscopic appearance(Early (post-operative day 10))
  • Late endoscopic appearance at 6 months(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Caroline Xu

Resident

University of Alberta

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Early Saline Irrigation to Decrease... | Clinical Trial