Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement

October 11, 2018 updated by: Caroline Xu, University of Alberta
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early saline irrigation
Initiation of early saline irrigation
Other: Early saline irrigation
Initiation of post-operative saline irrigation earlier during the post-operative course
Active Comparator: Late or Routine Saline Irrigation
Routine initiation of saline irrigation
Other: Early saline irrigation
Initiation of post-operative saline irrigation earlier during the post-operative course
Other: Routine Irrigation
Routine initiation of saline irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Early post-operative (Day 10)
Pain and discomfort during early post-operative debridement on post-operative day 10
Early post-operative (Day 10)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic appearance
Time Frame: Early (post-operative day 10)
Early post-operative POSE score on post-operative day 10
Early (post-operative day 10)
Late endoscopic appearance at 6 months
Time Frame: 6 months
Late post-operative endoscopic POSE score at 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ESESS-001
  • Pro00042764 (Other Identifier: HREB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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