Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Purpose The purpose of this study is to assess the efficacy of post-FESS nasal debridements in the prevention of post-operative synechiae formation.

Hypothesis 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.

Justification To prevent synechiae formation, many studies have been published evaluating the efficacy of post-operative debridement procedures. Many of these studies have shown conflicting results. There were many inconsistent variables between the studies, such as limited follow-up periods, varying extent of surgery, and variability in pre and post-operative treatment.

With a well designed study, we would like to assess if there is a difference in the incidence of formation of middle meatal synechiae between patients who have debridement and patients who don't.

This will further add much needed evidence to the need for this procedure in the post operative period following FESS.

Surgery The participants in this study will all undergo standard-of-care functional endoscopic sinus surgery (FESS) to treat their sinus disease. No changes will be made to pre-operative or operative protocol on account of this study. All post-operative standard-of-care procedures and medication will be maintained.

Follow up visits After FESS, participant subjects will be asked to return for 4 follow-up visits within the first 90 days and one follow-up visit at 180 days. They will be asked to return at 6, 30, 60, 90 and 180 days following their sinus surgery. At their 6 and 30 day follow-up visits they will either receive or not receive routine post-operative debridement depending on randomization.

Statistical Analysis

Sample size calculations A sample size calculation was performed to determine the appropriate number of patients required to adequately compare the incidence of synechiae between participants with versus without postoperative debridement following FESS. Previous investigations at the St. Paul's Sinus Centre have found that of post-FESS cases, 18% develop synechiae from use of gloved-Merocel middle meatal spacers. Utilizing a type I error of 5%, type II error of 20%, effect difference of 15% and 10% loss to follow-up, a total of 150 patients are required (75 per arm).

Statistical Comparisons The primary objective of this randomized controlled trial will be to compare the incidence of synechiae between subjects receiving debridement versus those receiving saline irrigation (no debridement) up to 180 days post-surgery. Count and absolute percentages of synechia incidence will be reported. The Chi-Squared test will be used to determine statistical significance between incidence rates. Probability values less than 5% (α=0.05) will be considered significant. Corresponding odds ratios and 95% confidence intervals will be reported.

For the secondary outcome measures (e.g. Sinonasal Outcomes Test 22 SNOT-22, PJESS/MLK), results will be summated and considered as continuous, numerical variables. Descriptive statistics using mean, median, standard deviation and inter-quartile ranges will be reported. The unpaired two sample student t-tests will be applied to investigate the difference between the means of the various outcome measures. Probability values less than 5% (α =0.05) will also be considered statistically significant.

Baseline demographics and clinical factors will be compared between each treatment group to determine whether randomization yielded comparable groups. Multivariable logistic and linear regression will be used to investigate the relationship between postoperative debridement and the primary (incidence of synechiae) or secondary outcomes (PJESS/MLK). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04093193
Study type Interventional
Source St. Paul's Hospital, Canada
Contact Amin Javer, MD FRCSCFARS
Phone 6048069926
Email sinusdoc@me.com
Status Recruiting
Phase N/A
Start date June 22, 2018
Completion date September 1, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05895929 - The Role of IL5 in Epithelial Cell Integrity Early Phase 1
Completed NCT03673956 - Topical Antibiotics in Chronic Rhinosinusitis Phase 1/Phase 2
Recruiting NCT03970655 - Functional Endoscopic Sinus Surgery Study Phase 1/Phase 2
Not yet recruiting NCT04514120 - Alsaleh-Javer Endoscopic Sinus Score (AJESS) System N/A
Recruiting NCT03963648 - NO Measurements in Screening for Asthma and OSA, in Patients With CRSwNP N/A
Recruiting NCT05009758 - Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps N/A
Active, not recruiting NCT05553951 - Adherence in Global Airways N/A
Completed NCT03563521 - Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma
Completed NCT05035654 - LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study) Phase 2
Withdrawn NCT03369574 - Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
Recruiting NCT05400616 - Nasal Microbiota Transfer Therapy in Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) N/A
Recruiting NCT04628442 - Tissue Immune Interaction in Nasal Polyposis
Completed NCT04041609 - LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) Phase 2
Completed NCT04048070 - The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery N/A
Recruiting NCT03439865 - Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis Early Phase 1
Recruiting NCT05857228 - Viral and Epigenetic Influences in CRSwNP
Completed NCT03122795 - Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) N/A
Recruiting NCT05295459 - Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2) Phase 3
Completed NCT04858802 - A Clinical Evaluation of PROPEL® Contour Sinus Implant N/A
Completed NCT04572516 - Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis Phase 3