Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02154555
Other study ID # POD_001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date December 31, 2018

Study information

Verified date February 2019
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 31, 2018
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
debridement
post-operative debridement at 1 week follow-up visit

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of synechiae - binary rating adhesions, scarring between middle turbinate and lateral nasal wall 1 week, 1 month, and 3 months after surgery
Secondary Change of Lund-Kennedy endoscopy score before surgery at clinical visit when consent for surgery is obtained (within 9 month period before surgery)
Secondary Change of pain score - 10-point Likert scale rated for each sinonasal cavity 1 week after surgery
Secondary 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)
Secondary 10-point Likert scale rated for each sinonasal cavity 1 month after surgery
Secondary pain score - 10-point Likert scale rated for each sinonasal cavity 3 months after surgery
Secondary Lund-Kennedy endoscopy score 1 week after surgery
Secondary Lund-Kennedy endoscopy score 1 month after surgery
Secondary Lund-Kennedy endoscopy score 3 months after surgery
Secondary SNOT-22 score 22-item sinonasal outcome test (SNOT-22) questionnaire score 1 week after surgery
Secondary SNOT-22 score 22-item sinonasal outcome test (SNOT-22) questionnaire score 1 month after surgery
Secondary SNOT-22 score 22-item sinonasal outcome test (SNOT-22) questionnaire score 3 months after surgery
Secondary 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)
See also
  Status Clinical Trial Phase
Completed NCT04131686 - NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis
Completed NCT02692794 - Large Scale Cerebral Oximetry During Sinus Endoscopy N/A
Completed NCT01988779 - Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations Phase 3
Completed NCT01254916 - The Sinonasal Outcome Test - 22, Validated for Danish Patients N/A
Completed NCT03614923 - Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Phase 2
Completed NCT03781804 - Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps Phase 3
Completed NCT01198912 - Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial Phase 2
Active, not recruiting NCT06457100 - Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery Phase 1/Phase 2
Completed NCT03280537 - A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps Phase 3
Terminated NCT02285283 - Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps Phase 2/Phase 3
Completed NCT02307825 - Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy Phase 4
Completed NCT02218307 - The Use of Antibiotic Sinonasal Rinse After Sinus Surgery Phase 4
Recruiting NCT01024075 - Effect of Sinufoam-Dexamethasone Mixture on Post Endoscopic Sinus Surgery Outcomes Phase 4
Completed NCT01002313 - Effect of Prednisone onTregs and TH17 Phase 1
Completed NCT00396162 - Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis Phase 4
Completed NCT03280550 - A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps Phase 3
Recruiting NCT05935683 - Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis
Completed NCT03478930 - An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps Phase 3
Completed NCT01943370 - Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement N/A
Completed NCT01778465 - Effect of Dietary Salicylate in Aspirin Exacerbated Respiratory Disease N/A