Debridement and Functional Endoscopic Sinus Surgery

NCT04093193 | Unknown

• 1 other identifier: H15-02071
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Keywords

Functional Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

• Change in Postoperative Synechiae

  The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence).

  Day 30, 60, 90, and 180 follow-up visits.

Secondary Outcomes (3)

• Sinonasal Outcomes Test - 22 (SNOT-22)

  Day 30, 60, 90, and 180 follow-up visits.

• Philpott-Javer (PJ) and Modified Lund-Kennedy (MLK) Endoscopic Staging System (ESS)

  Day 30, 60, 90, and 180 follow-up visits.

• Visual Analog Score (VAS) for pain and discomfort

  Day 6, 30, 60, 90, and 180 follow-up visits.

Study Arms (2)

Debridement group

EXPERIMENTAL

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

Procedure: Debridement

Non Debridement Group

NO INTERVENTION

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

Interventions

Debridement PROCEDURE

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

Debridement group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

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

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Related Publications (16)

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• Green R, Banigo A, Hathorn I. Postoperative nasal debridement following functional endoscopic sinus surgery, a systematic review of the literature. Clin Otolaryngol. 2015 Feb;40(1):2-8. doi: 10.1111/coa.12330.

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  PMID: 12825038 BACKGROUND

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  PMID: 22487908 BACKGROUND

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  PMID: 8196032 BACKGROUND

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  PMID: 17075402 BACKGROUND

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  PMID: 17960410 BACKGROUND

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  PMID: 24294687 BACKGROUND

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  PMID: 18641526 BACKGROUND

MeSH Terms

Conditions

Disease

Interventions

Debridement

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Amin Javer, MD FRCSCFARS

CONTACT

6048069926; sinusdoc@me.com

India Dhillon, BSc

CONTACT

6048069926; idhillon3@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The patient will know if he/she is getting debridement or not. The PI will comment on all the objective outcome measures and will be the blinded assessor (he will not perform the debridements).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, St. Paul's Sinus Centre

Model Details: There will be two possible scenarios resulting from randomization: 1. The patient is randomized to the arm that receives routine post-operative debridement (treatment group). 2. The patient is randomized to the arm that will not receive post-operative debridement (control group).

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: September 17, 2019
• Study Start: June 22, 2018
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)