The Effect of Modified Radical Endoscopic Sinus Surgery on Eosinopilic Chronic Rhinosinusitus With Nasal Polyps

  • STATUS
    Recruiting
  • End date
    Dec 6, 2023
  • participants needed
    110
  • sponsor
    Zheng Liu
Updated on 30 April 2021

Summary

Functional endoscopic sinus surgery (FESS) is the pimary surgical treatment of CRS, characterized with the preservation of nasal structure and function.But the control of disease by surgery has been unsatisfactory. Recent studies have shown that patients with recurrent CRSwNP (usually with severe eosinophilic inflammation), more radical surgery may be more effective. The purpose of this prospective and randomized study is to determine the effect of endoscopic sinus surgery for extensive mucosal removal in patients with eosinophilic chronic rhinosinusitus with nasal polyps.

Description

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disorder that causes various symptoms including nasal obstruction, rhinorrhea, olfactory dysfunction, facial pain, and headache. Patients with significant eosinophilic inflammation usually accompanied with a higher recurrence rate and more severe clinical symptoms. Endoscopic sinus surgery (ESS) is recommended to patients who do not response well to conservative treatments. A retrospective study showed that postoperative polyp recurrence rate of patients with severe eosinophilic inflammation was significantly reduced by rebooting sinus mucosa. In this study, the experimental group intends to adopt a modified radical surger to remove the mucosa including ethmoid sinus and maxillary sinus, as well as a completly middle turbinate resection to achieve a extensive treatment of ethmoid sinus. Antrostomies of frontal and sphenoid sinuses were then performed with meticulous operation and preserve the mucosa intactly.

Details
Condition Nasal polyp, Polyp, Polyps, Chronic Sinusitis, Chronic Rhinosinusitis, Endoscopic Sinus Surgery, Polyps, nasal polyps
Treatment Functional Endoscopic Sinus Surgery, Modified radical endoscopic sinus surgery
Clinical Study IdentifierNCT04852562
SponsorZheng Liu
Last Modified on30 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

CRSwNP is diagnosed according to EPOS clinical guidelines and met surgical requirements, the blood eosinophil count was greater than 0.22
Subjects/legal authorized representatives must understand the purpose and procedures of the study and voluntarily sign the informed consent, voluntarily participate in the study and comply with the study regulations, understand and comply with follow-up plan, and can correctly record the scale score, the administration frequency, accompanying drug use and adverse events, etc
The examinee must be 18-65 years old, male or non pregnant female, limited to Chinese
During the treatment and follow-up period, female subjects have no pregnancy and lactation plans
The subjects did not participate in other clinical trials in the past three months and agreed not to participate in other clinical trials before reaching the end point of this trial
Patients accompanying asthma must use their regular asthma treatment steadily in the past 6 weeks

Exclusion Criteria

Women must not be pregnant, or breast-feeding
Subjects with cystic fibrosis, congenital ciliary dyskinesia, fungal sinusitis, systemic vasculitis and granulomatous disease, tumor, and immunodeficiency are exclued
Subjects accpted nasal endoscopic surgery within 6 months are exclued
Subjects with an upper respiratory tract infection within 4 weeks of entering the study are excluded
Subjects with serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, or respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects safety are excluded, such as glaucoma and tuberculosis
Currently participating in other clinical studies or in other clinical investigators within 30 days, or staff directly involved in this study
Subjects with emotional or mental problems are excluded
Subjects must not have received immunotherapy within the previous 3 months
Subjects unsuitable for inclusion based on judgement of researchers are excluded
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