A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery

NCT02154555 | Completed

• 1 other identifier: POD_001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Change of synechiae - binary rating

  adhesions, scarring between middle turbinate and lateral nasal wall

  1 week, 1 month, and 3 months after surgery

Secondary Outcomes (12)

• 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

  1 week after surgery

• Change of SNOT-22 score

  before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)

• 10-point Likert scale

  1 month after surgery

• pain score - 10-point Likert scale

  3 months after surgery

Study Arms (2)

no debridement

NO INTERVENTION

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.

debridement

EXPERIMENTAL

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

Interventions

debridement PROCEDURE

post-operative debridement at 1 week follow-up visit

debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Interventions

Debridement

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• John Lee, MD, FRCSC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: June 3, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: December 31, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)