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Debridement and Functional Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04093193
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (Diagnosis) Procedure: Debridement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).
Masking: Single (Investigator)
Masking Description: 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).
Primary Purpose: Treatment
Official Title: The Efficacy of Debridement of the Sinus Cavity Following Primary Functional Endoscopic Sinus Surgery (FESS): A Randomized Controlled Trial.
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Debridement group
Patients receive routine post-operative debridement at their Day 6, 30 and 60 follow up appointments.
Procedure: Debridement
Debridement or cleaning of the sinuses post-operatively has been described as a regular post-surgery procedure .

No Intervention: Non Debridement Group
Patients will not receive debridement at any follow up visit after surgery. They will continue with saline irrigation.



Primary Outcome Measures :
  1. Change in Postoperative Synechiae [ Time Frame: Day 30, 60, 90, and 180 follow-up visits. ]
    The existence of postoperative synechiae will be considered as a categorical, dichotomous outcome variable (presence or absence).


Secondary Outcome Measures :
  1. Sinonasal Outcomes Test - 22 (SNOT-22) [ Time Frame: Day 30, 60, 90, and 180 follow-up visits. ]

    The SNOT-22 is a sinus-specific questionnaire that evaluates subjective symptoms for patients suffering from chronic rhinosinusitis.

    SNOT-22 is scored out of 110 (22 questions, up to 5-points each) has demonstrated internal consistency, reliability, discriminate and concurrent validity and responsiveness to change. Responses will be summated and considered as a continuous, numerical variable.


  2. Philpott-Javer (PJ) and Modified Lund-Kennedy (MLK) Endoscopic Staging System (ESS) [ Time Frame: Day 30, 60, 90, and 180 follow-up visits. ]
    Sinonasal mucosal inflammation is an objective measure assessed endoscopically and graded on both the PJ and MLK ESS for CRS.

  3. Visual Analog Score (VAS) for pain and discomfort [ Time Frame: Day 6, 30, 60, 90, and 180 follow-up visits. ]
    The visual analog score describes subjective pain and discomfort levels experienced by the participant following the procedures in both arms of the study.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093193


Contacts
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Contact: Amin Javer, MD FRCSCFARS 6048069926 sinusdoc@me.com
Contact: India Dhillon, BSc 6048069926 idhillon3@providencehealth.bc.ca

Locations
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Canada, British Columbia
E.N.T Clinic, St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: India Dhillon, BSc    604-806-9926    idhillon3@providencehealth.bc.ca   
Principal Investigator: Amin R Javer, MD FRCSCFARS         
Sponsors and Collaborators
St. Paul's Hospital, Canada

Publications:

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Responsible Party: Amin Javer, Director, St. Paul's Sinus Centre, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT04093193    
Other Study ID Numbers: H15-02071
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication will be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amin Javer, St. Paul's Hospital, Canada:
Functional Endoscopic Sinus Surgery
Additional relevant MeSH terms:
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Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes