A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery

Conditions
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Chronic Rhinosinusitis

Intervention / Treatment
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* Procedure: debridement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no debridement<br>The postoperative clinical visits will occur at one week, one month, and three months following surgery. During all three postoperative visits, no debridement will be performed. | |
| Experimental: debridement<br>The postoperative clinical visits will occur at one week, one month, and three months following surgery. During the one week postoperative visit, the randomized unilateral debridement will be performed. Debridement includes removing any crust or mucous in the nose. During the one month and three month visit, the PI will only examine the nose. | Procedure: debridement<br>* post-operative debridement at 1 week follow-up visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of synechiae - binary rating | adhesions, scarring between middle turbinate and lateral nasal wall | 1 week, 1 month, and 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Lund-Kennedy endoscopy score |  | before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery) | 
| Change of pain score - 10-point Likert scale | rated for each sinonasal cavity | 1 week after surgery | 
| Change of SNOT-22 score | 22-item sinonasal outcome test (SNOT-22) questionnaire score | before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery) | 
| 10-point Likert scale | rated for each sinonasal cavity | 1 month after surgery | 
| pain score - 10-point Likert scale | rated for each sinonasal cavity | 3 months after surgery | 
| Lund-Kennedy endoscopy score |  | 1 week after surgery | 
| Lund-Kennedy endoscopy score |  | 1 month after surgery | 
| Lund-Kennedy endoscopy score |  | 3 months after surgery | 
| SNOT-22 score | 22-item sinonasal outcome test (SNOT-22) questionnaire score | 1 week after surgery | 
| SNOT-22 score | 22-item sinonasal outcome test (SNOT-22) questionnaire score | 1 month after surgery | 
| SNOT-22 score | 22-item sinonasal outcome test (SNOT-22) questionnaire score | 3 months after surgery | 
| pain score - 10-point Likert scale | rated for each sinonasal cavity | before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery) |