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A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery

A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02154555
Enrollment
30
Registered
2014-06-03
Start date
2014-05-31
Completion date
2018-12-31
Last updated
2019-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis

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.

Interventions

PROCEDUREdebridement

post-operative debridement at 1 week follow-up visit

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of synechiae - binary rating1 week, 1 month, and 3 months after surgeryadhesions, scarring between middle turbinate and lateral nasal wall

Secondary

MeasureTime frameDescription
Change of pain score - 10-point Likert scale1 week after surgeryrated for each sinonasal cavity
Change of SNOT-22 scorebefore surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)22-item sinonasal outcome test (SNOT-22) questionnaire score
10-point Likert scale1 month after surgeryrated for each sinonasal cavity
Change of Lund-Kennedy endoscopy scorebefore surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
Lund-Kennedy endoscopy score1 week after surgery
SNOT-22 score1 week after surgery22-item sinonasal outcome test (SNOT-22) questionnaire score
pain score - 10-point Likert scale3 months after surgeryrated for each sinonasal cavity

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026