A Study of Different Endoscopic Surgery Procedures in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Not Applicable

Completed

• Conditions: Chronic Rhinosinusitis (Diagnosis); Surgery
• Interventions: Procedure: functional endoscopic sinus surgery (FESS); Procedure: radical endoscopic sinus surgery (RESS); Procedure: radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.

• Registration Number: NCT03878355
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

CRS remains a common challenging clinical entity due to variable phenotypes with different underlying mechanisms that lead to persistence or recurrence polyps. The eosinophils dominant inflammation was considered as a major pathological hallmark and challenges of CRS with nasal polyps (CRSwNP). Differentiate surgical approaches towards eosinophilic CRSwNP (eCRSwNP) should be addressed on the basis of the inflammatory endotypes. eCRSwNP has been recognized as the most easily relapsed type of CRS, and the combination of asthma increases the difficulty of treatment. Till now there is no recognized surgical strategy for eCRSwNP with asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2013-10-31
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-14
• Last Update Submitted: 2019-03-14
• Study First Posted: 2019-03-18
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• The diagnosis of CRSwNP was based on the standard criteria issued in the European Position Paper on Rhinosinusitis and Nasal Polyps guidelines.
• Participants had at least 1 previous sinus surgery underwent FESS (middle turbinate (MT) preserved), good gasification of frontal sinus and with concomitant asthma.
• The diagnosis of asthma was confirmed by a chest physician according to Global Initiative for Asthma (GINA) guidelines.
• Polyp biopsy was undertaken 1 week before surgery and the eCRSwNP was confirmed by the number of eosinophils exceeded 10% of total infiltrating inflammatory cells in the polyp tissue through the evaluation by using hematoxylin and eosin (H&E) staining.

Exclusion Criteria

• Patients were excluded if they had unilateral disease, allergic fungal rhinosinusitis, antrochoanal polyps, or cysts.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
functional endoscopic sinus surgery	functional endoscopic sinus surgery (FESS)	-
radical endoscopic sinus surgery	radical endoscopic sinus surgery (RESS)	-
radical endoscopic sinus surgery plus Draf 3 surgery	radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.	-

Primary Outcome Measures

Name	Time	Method
recurrence	5 years after surgery	Recurrence was defined if the patient had symptoms of chronic rhinosinusitis after surgery, and nasal endoscopy found nasal polyps recurrence, obvious edema of mucosa, or purulent secretion, and above of symptoms or physical signs existed, which can't be alleviated by maximum medicine treatment at least 1 month

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale of 4 major clinical symptoms	at baseline, and 1 year, 3years, 5 years after surgery	Subjective symptoms were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable. Four major symptoms include nasal congestion, rhinorrhea, loss of smell, and headache and/or facial pain.
Sinus-specific quality of life (QoL)	at baseline, and 1 year, 3years, 5 years after surgery	Sinus-specific quality of life (QoL) was assessed using the 22-item Sinonasal Outcome Test (SNOT-22)
Postoperatively endoscopic results	at baseline, and 1 year, 3years, 5 years after surgery	Postoperatively endoscopic results were scored according to the Lund-Kennedy system, with the assessment of edema, nasal discharge, scarring, and crusting