Chronic Rhinosinusitis Clinical Trial
Official title:
A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery
Chronic rhinosinusitis (CRS) is a common sinus and nasal condition affecting more than 33
million Americans. The treatment of CRS typically begins with maximal medical therapy
however, when this fails to improve patient symptoms, surgical intervention is considered.
Endoscopic sinus surgery (ESS) is a well-established treatment for refractory CRS with
approximately 600,000 sinus surgeries performed annually in the United States alone. Despite
the success of this intervention, up to 26% of patients experience complications following
surgery, including middle meatal (MM) synechiae, edema, polyp recurrence, and middle
turbinate lateralization. Currently, there is no consensus as to the postoperative care
regime that is most effective at minimizing or preventing these potential complications.
Therefore there is need for further study into the role of debridement, examining patients
undergoing endoscopic sinus surgery while concurrently addressing the potential confounders
of maximal medical therapies in the postoperative setting.
This prospective, randomized, single-blind, controlled study design will investigate the
efficacy of postoperative debridement following ESS. Patients who have undergone ESS will
have one nare randomized to debridement and the other to no debridement at the first week
post-operative visit. In this way, the patients will act as their own controls in order to
account for inter-patient variability in disease severity. The primary outcome will assess
synechiae formation attributed to ESS. Secondary outcomes will include pain (side-specific)
attributed to the debridement procedure as well as comparing pre and post endoscopy scores
and SNOT-22 questionnaire responses.
The significant heterogeneity present in the current literature regarding the use of
postoperative debridement warrants additional studies that document postoperative protocols
and use universally accepted endoscopy scores in order to consistently track patient
outcomes. Further investigation into the efficacy of postoperative debridement is especially
interesting with the potential benefits of further reduced synechiae formation and edema.
Conversely, if objective evidence fails to demonstrate benefit of postoperative debridement,
there could be significant cost and time saving for healthcare professionals in removing this
therapy from the postoperative protocols.
We hypothesize that postoperative debridement will have a significant effect on reducing the
rates of synechiae formation. In addition, we hypothesize that this improvement in synechiae
development will also be matched by improvements in postoperative endoscopic sinus scoring,
and patient's overall symptoms at 1 and 3 months postoperatively.
This study can clarify the efficacy of postoperative debridement and the potential benefits
of further reduced synechiae formation and edema, and thus decrease the rates of complication
and revision surgery. Conversely, if objective evidence fails to demonstrate benefit of
postoperative debridement, there could be significant cost and time saving for healthcare
professionals in removing this therapy from the postoperative protocols.
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