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.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis
• Intervention / Treatment: Procedure: debridement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: no debridement; 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; 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; post-operative debridement at 1 week follow-up visit

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: John Lee, MD, FRCSC, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 25, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: POD_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO