Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement

NCT ID: NCT01943370

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Early saline irrigation

Initiation of early saline irrigation

Group Type EXPERIMENTAL

Early saline irrigation

Intervention Type OTHER

Initiation of post-operative saline irrigation earlier during the post-operative course

Late or Routine Saline Irrigation

Routine initiation of saline irrigation

Group Type ACTIVE_COMPARATOR

Early saline irrigation

Intervention Type OTHER

Initiation of post-operative saline irrigation earlier during the post-operative course

Routine Irrigation

Intervention Type OTHER

Routine initiation of saline irrigation

Interventions

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Early saline irrigation

Initiation of post-operative saline irrigation earlier during the post-operative course

Intervention Type OTHER

Routine Irrigation

Routine initiation of saline irrigation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Caroline Xu

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Pro00042764

Identifier Type: OTHER

Identifier Source: secondary_id

ESESS-001

Identifier Type: -

Identifier Source: org_study_id

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