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

Last updated: September 3, 2025
Sponsor: Zheng Liu
Overall Status: Completed

Phase

N/A

Condition

Sinus Infections

Sinusitis

Polyps

Treatment

Modified radical endoscopic sinus surgery

functional endoscopic sinus surgery

Clinical Study ID

NCT04852562
ENTmodifiedRESS-01
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CRSwNP is diagnosed according to EPOS clinical guidelines and met surgicalrequirements, the blood eosinophil count was greater than 0.22;

  • Subjects/legal authorized representatives must understand the purpose and proceduresof the study and voluntarily sign the informed consent, voluntarily participate inthe study and comply with the study regulations, understand and comply withfollow-up plan, and can correctly record the scale score, the administrationfrequency, accompanying drug use and adverse events, etc;

  • The examinee must be 18-65 years old, male or non pregnant female, limited toChinese;

  • During the treatment and follow-up period, female subjects have no pregnancy andlactation plans;

  • The subjects did not participate in other clinical trials in the past three monthsand agreed not to participate in other clinical trials before reaching the end pointof this trial;

  • Patients accompanying asthma must use their regular asthma treatment steadily in thepast 6 weeks;

Exclusion

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 areexclued;

  • Subjects accpted nasal endoscopic surgery within 6 months are exclued;

  • Subjects with an upper respiratory tract infection within 4 weeks of entering thestudy are excluded;

  • Subjects with serious metabolic, cardiovascular, autoimmune, neurology, blood,digestive, cerebrovascular, or respiratory system disease, or any diseaseinterfering with the evaluation of results or affecting subjects safety areexcluded, such as glaucoma and tuberculosis;

  • Currently participating in other clinical studies or in other clinical investigatorswithin 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;

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Modified radical endoscopic sinus surgery
Phase:
Study Start date:
December 06, 2020
Estimated Completion Date:
July 26, 2024

Study 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.

Connect with a study center

  • Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949 430030
    China

    Site Not Available

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