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

Capital Medical University

Status: Completed

Conditions: Surgery; Chronic Rhinosinusitis (Diagnosis)

Treatments: Procedure: radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.; Procedure: radical endoscopic sinus surgery (RESS); Procedure: functional endoscopic sinus surgery (FESS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03878355

TR-ES

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 24 to 71 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

radical endoscopic sinus surgery plus Draf 3 surgery

Experimental group

Treatment:

Procedure: radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.

radical endoscopic sinus surgery

Experimental group

Treatment:

Procedure: radical endoscopic sinus surgery (RESS)

functional endoscopic sinus surgery

Experimental group

Treatment:

Procedure: functional endoscopic sinus surgery (FESS)