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OpenTrials
Completed

NCT Number: NCT01943370

Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement

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.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early saline irrigation

Other

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

Routine Irrigation

Other

Routine initiation of saline irrigation

Primary outcomes

  1. Pain

    Time frame: Early post-operative (Day 10)

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

Secondary outcomes

  1. Endoscopic appearance

    Time frame: Early (post-operative day 10)

    Early post-operative POSE score on post-operative day 10

  2. Late endoscopic appearance at 6 months

    Time frame: 6 months

    Late post-operative endoscopic POSE score at 6 months

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2013
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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