Alsaleh-Javer Endoscopic Sinus Score (AJESS) System

NCT04514120 | Unknown

• 1 other identifier: H20-02108
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

Several endoscopic scores have been developed to assess Chronic Rhinosinusitis severity like the Modified Lund-Kennedy (MLK). This is a simple score only based on endoscopic signs. We proposed a more descriptive Alsaleh-Javer Endoscopic Sinus Score (AJESS) system which assesses all sinuses and nasal passages based on participant's severity of symptoms too. This would be a more reliable and clinically valid CRS endoscopic score. We aim to study thE AJESS system in 100 participants with stable CRS and 30 participants CRS who are experiencing an exacerbation (worsening of CRS).

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Chronic Rhinosinusitis; Endoscopic score

Outcome Measures

Primary Outcomes (1)

• Test-retest and inter-rater reliability of the AJESS compare to MLK scores.

  Baseline

Secondary Outcomes (3)

• Change in the SNOT-22 between the AJESS and MLK in stable participants

  Baseline

• Change in the VAS between the AJESS and MLK score in stable participants

  Baseline

• Change in the Sniffin' Stick TDI between the AJESS and MLK score in stable participants

  Baseline

Other Outcomes (4)

• Change in SNOT-22 between the AJESS and MLK score in exacerbated patients

  Baseline and 3 weeks

• Change in SNOT-22 between the AJESS and MLK score in exacerbated patients

  Baseline and 6 weeks

• Change in the VAS between the AJESS and MLK score in exacerbated participants

  Baseline and 3 weeks

Study Arms (2)

Stable CRS

EXPERIMENTAL

Patients diagnosed with Chronic Rhinosinusitis including those with or without nasal polyposis and/or with Allergic Fungal Rhinosinusitis and stable condition

Other: AJESS scoring process

Non-stable CRS

EXPERIMENTAL

Patients diagnosed with Chronic Rhinosinusitis including those with or without nasal polyposis and with Allergic Fungal Rhinosinusitis who are experiencing an exacerbation

Other: AJESS scoring process

Interventions

AJESS scoring process OTHER

We will collecto endoscopic pictures from stable and non stable participants. Pictures will be taken for each sinus, olfactory cleft, and middle meatus in private clinical exam rooms. For each anatomic site \[left middle meatus (LMM), left ethmoid sinus (LES), left frontal sinus (LFS), left maxillary sinus (LMS), left olfactory cleft (LOC), left sphenoid sinus (LSS), right middle meatus (RMM), right ethmoid sinus (RES), right frontal sinus (RFS), right maxillary sinus (RMS), right olfactory cleft (ROC), right sphenoid sinus (RSS)\], numerical scores describe edema or polyposis while alphabetical scores, in lower case or upper case corresponding to severity, describe CRS features: crusting, synechiae, purulence, mucus, recirculation, and ostial narrowness.

Non-stable CRS; Stable CRS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are over 19 years old
• Patients diagnosed with Chronic Rhinosinusitis including those with or without nasal polyposis and with Allergic Fungal Rhinosinusitis
• Post-operative patients

You may not qualify if:

• Have a sinonasal neoplasm
• Have syndromic sinusitis e.g. cystic fibrosis or vasculitis

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Atenea Pascual

CONTACT

(604) 806-9926; apascual@providencehealth.bc.ca

Laura Samson

CONTACT

(604) 806-9926; lsamson2@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is not a blinded study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: This mixed-methods clinical study of patients with CRS includes both a cross-sectional arm (single participant encounter with stable patients, n=100) and a second prospective aspect (3 participant encounters with patients experiencing CRS exacerbation, n=30)

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: August 14, 2020

Record last verified: 2020-08