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

NCT ID: NCT04852562

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-06
• Study Completion Date: 2024-07-26

Brief 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.

Detailed 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.

Conditions

Chronic Sinusitis; Endoscopic Sinus Surgery; Nasal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Modified radical endoscopic sinus surgery(MRESS)

The experimental group intends to adopt a modified radical endoscopic sinus surger to remove the mucosa including ethmoid sinus and maxillary sinus, as well as a completly middle turbinate resection to achieve a radical cure of ethmoid sinus. Antrostomies of frontal and sphenoid sinuses were then performed with meticulous operation and preserve the mucosa intactly.

Group Type: EXPERIMENTAL

Modified radical endoscopic sinus surgery

Intervention Type: PROCEDURE

Modified radical endoscopic sinus surgery was performed to remove the mucosa including ethmoid sinus and maxillary sinus, as well as a completly middle turbinate.

Functional endoscopic sinus surgery (FESS)

FESS was performed by Messerklinger technique, operation procedures including full maxillary antrostomy, ethmoidectomy, sphenoidotomy and frontal sinusotomy, but with the middle turbinate preservation.

Group Type: EXPERIMENTAL

functional endoscopic sinus surgery

Intervention Type: PROCEDURE

Full maxillary antrostomy, ethmoidectomy, sphenoidotomy and frontal sinusotomy, but with the middle turbinate preservation.

Interventions

Modified radical endoscopic sinus surgery

Modified radical endoscopic sinus surgery was performed to remove the mucosa including ethmoid sinus and maxillary sinus, as well as a completly middle turbinate.

Intervention Type: PROCEDURE

functional endoscopic sinus surgery

Full maxillary antrostomy, ethmoidectomy, sphenoidotomy and frontal sinusotomy, but with the middle turbinate preservation.

Intervention Type: PROCEDURE

Other Intervention Names

MRESS; FESS

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan Central Hospital

OTHER

Sponsor Role: collaborator

Wuhan No.1 Hospital

OTHER

Sponsor Role: collaborator

Tianyou Hospital Affiliated to Wuhan University of Science and Technology

OTHER

Sponsor Role: collaborator

Wuhan Third Hospital

OTHER

Sponsor Role: collaborator

Wuhan Pu-Ai Hospital

OTHER

Sponsor Role: collaborator

Zheng Liu

OTHER

Sponsor Role: lead

Responsible Party

Zheng Liu

Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zheng Liu, Doctor

Role: STUDY_CHAIR

Huazhong University of Science and Technology

Locations

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

Wuhan, Hubei, China

Countries

China

Other Identifiers

ENTmodifiedRESS-01

Identifier Type: -

Identifier Source: org_study_id