Debridement and Functional Endoscopic Sinus Surgery
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|ClinicalTrials.gov Identifier: NCT04093193|
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis (Diagnosis)||Procedure: Debridement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
There will be two possible scenarios resulting from randomization:
|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).|
|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|
Experimental: Debridement group
Patients receive routine post-operative debridement at their Day 6, 30 and 60 follow up appointments.
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.
- 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).
- 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.
- 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.
- 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.
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
|Contact: Amin Javer, MD FRCSCFARSfirstname.lastname@example.org|
|Contact: India Dhillon, BScemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Amin R Javer, MD FRCSCFARS|