Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement

Chronic Rhinosinusitis Clinical Trial

Official title:

Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943370
• Other study ID #: ESESS-001
• Secondary ID: Pro00042764
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis

Intervention

Other:
• Early saline irrigation
Initiation of post-operative saline irrigation earlier during the post-operative course
• Routine Irrigation
Routine initiation of saline irrigation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain and discomfort during early post-operative debridement on post-operative day 10	Early post-operative (Day 10)
Secondary	Endoscopic appearance	Early post-operative POSE score on post-operative day 10	Early (post-operative day 10)
Secondary	Late endoscopic appearance at 6 months	Late post-operative endoscopic POSE score at 6 months	6 months