A Randomized Controlled Trial Evaluating Postoperative Debridement Following Endoscopic Sinus Surgery

NCT ID: NCT02154555

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-12-31

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.

Conditions

Chronic Rhinosinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

debridement

Intervention Type: PROCEDURE

post-operative debridement at 1 week follow-up visit

Interventions

debridement

post-operative debridement at 1 week follow-up visit

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Lee, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

POD_001

Identifier Type: -

Identifier Source: org_study_id