Recruiting

Debridement & FESS

Sponsor:

St. Paul's Hospital, Canada

Code:

NCT04093193

Conditions

Chronic Rhinosinusitis (Diagnosis)

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Debridement

Study Details

Brief summary:

Functional endoscopic sinus surgery (FESS) is the gold standard surgical intervention for management of patients with chronic rhinosinusitis (CRS). Synechiae formation in the middle meatus is the most common complication of endoscopic sinus surgery after FESS. Nasal debridement is a postoperative procedure used in the prevention of synechiae formation. This procedure lacks standardized evidence-based guidelines. The currently existing studies that have been conducted to determine the efficacy of post-operative debridement have shown conflicting results. We hypothesize that there is no difference in short and long term clinical outcomes between patients who had routine post-operative nasal debridement following FESS and patients who did not have post-operative nasal debridement.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Study ID

NCT04093193

Start date

Jun 22, 2018

Status verified date

Sep, 2019

Completion date

Sep 1, 2021

Anticipated

Primary completion date

Jul 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Over the age of 19;
  • Have chronic sinus disease (CRS) and are scheduled to undergo sinus surgery on both sides of your nose for the first time.

Exclusion Criteria:

  • Unable to speak English;
  • Are having surgery for the removal of a nasal tumor;
  • Have a disorder of your immune system in which your body's immune system attacks itself (autoimmune disorder)
  • Diagnosed with cystic fibrosis
  • Have had sinus surgery in the past
  • Are scheduled to have a procedure known as nasal septal reconstruction, without additional sinus surgery

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Debridement group

Patients receive routine post-operative debridement at their Day 6, 30 and 60 follow up appointments.

no intervention: Non Debridement Group

Patients will not receive debridement at any follow up visit after surgery. They will continue with saline irrigation.

Interventions

Debridement

Debridement or cleaning of the sinuses post-operatively has been described as a regular post-surgery procedure .

Primary outcome measure

  • Change in Postoperative Synechiae [ Time Frame: Day 30, 60, 90, and 180 follow-up visits. ]

Central Contacts and Locations

Central contacts

Amin Javer, MD FRCSCFARS

6048069926sinusdoc@me.com

India Dhillon, BSc

6048069926idhillon3@providencehealth.bc.ca

Locations

E.N.T Clinic, St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

India Dhillon, BSc

604-806-9926idhillon3@providencehealth.bc.ca

Principal Investigator:

Amin R Javer, MD FRCSCFARS

More Information

Sponsor

St. Paul's Hospital, Canada

Last update posted

Sep 19, 2019

Last verified

Sep, 2019

Keywords

  • Functional Endoscopic Sinus Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Paul's Hospital, Canada on 2019-09-19.