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NCT Number: NCT02154555

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Debridement

Procedure

post-operative debridement at 1 week follow-up visit

Primary outcomes

  1. Change of synechiae - binary rating

    Time frame: 1 week, 1 month, and 3 months after surgery

    adhesions, scarring between middle turbinate and lateral nasal wall

Secondary outcomes

  1. Change of Lund-Kennedy endoscopy score

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

  2. Change of pain score - 10-point Likert scale

    Time frame: 1 week after surgery

    rated for each sinonasal cavity

  3. Change of SNOT-22 score

    Time frame: before 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

  4. 10-point Likert scale

    Time frame: 1 month after surgery

    rated for each sinonasal cavity

  5. pain score - 10-point Likert scale

    Time frame: 3 months after surgery

    rated for each sinonasal cavity

  6. Lund-Kennedy endoscopy score

    Time frame: 1 week after surgery

  7. Lund-Kennedy endoscopy score

    Time frame: 1 month after surgery

  8. Lund-Kennedy endoscopy score

    Time frame: 3 months after surgery

  9. SNOT-22 score

    Time frame: 1 week after surgery

    22-item sinonasal outcome test (SNOT-22) questionnaire score

  10. SNOT-22 score

    Time frame: 1 month after surgery

    22-item sinonasal outcome test (SNOT-22) questionnaire score

  11. SNOT-22 score

    Time frame: 3 months after surgery

    22-item sinonasal outcome test (SNOT-22) questionnaire score

  12. pain score - 10-point Likert scale

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

    rated for each sinonasal cavity

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jun 3, 2014
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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