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).