Clinical trial NCT02154555: A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery
Official title: A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Chronic Rhinosinusitis (as defined by the American Academy of Otolaryngology - Head \& Neck Surgery)
* Consented to proceed with bilateral ESS
* Require bilateral middle meatus spacers postoperatively
* Adequate fluency in English to provide consent and complete surveys

Exclusion Criteria:

* History of immune deficiency
* Allergic fungal sinusitis
* Cystic Fibrosis

Primary outcomes:
measure: Change of synechiae - binary rating
timeFrame: 1 week, 1 month, and 3 months after surgery
Secondary outcomes:
measure: Change of Lund-Kennedy endoscopy score
timeFrame: before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
measure: Change of pain score - 10-point Likert scale
timeFrame: 1 week after surgery
measure: Change of SNOT-22 score
timeFrame: before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
measure: 10-point Likert scale
timeFrame: 1 month after surgery
measure: pain score - 10-point Likert scale
timeFrame: 3 months after surgery
measure: Lund-Kennedy endoscopy score
timeFrame: 1 week after surgery
measure: Lund-Kennedy endoscopy score
timeFrame: 1 month after surgery
measure: Lund-Kennedy endoscopy score
timeFrame: 3 months after surgery
measure: SNOT-22 score
timeFrame: 1 week after surgery
measure: SNOT-22 score
timeFrame: 1 month after surgery
measure: SNOT-22 score
timeFrame: 3 months after surgery
measure: pain score - 10-point Likert scale
timeFrame: before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: John Lee, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: