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

NCT04852562 | Completed DMC

• 1 other identifier: ENTmodifiedRESS-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Sinusitis; Endoscopic Sinus Surgery; Nasal Polyps

Keywords

eosinophilic chronic rhinosinusitus with nasal polyps.; endoscopic sinus surgery; Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention

  The SNOT-22 is a validated questionnaire that was used to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life.

  1month, 3month, 6month, 12month

Secondary Outcomes (6)

• Revision surgery rate

  12month

• Symptom duration

  1month, 3month, 6month, 12month

• Postoperative medication

  1month, 3month, 6month, 12month

• Recurrence time

  1month, 3month, 6month, 12month

• Change from baseline at months 1, 3, 6 and 12 in visual analogue scale (VAS) after surgical intervention

  1month, 3month, 6month, 12month

Other Outcomes (1)

• Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid

  1month, 3month, 6month, 12month

Study Arms (2)

Modified radical endoscopic sinus surgery(MRESS)

EXPERIMENTAL

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.

Procedure: Modified radical endoscopic sinus surgery

Functional endoscopic sinus surgery (FESS)

EXPERIMENTAL

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

Procedure: functional endoscopic sinus surgery

Interventions

Modified radical endoscopic sinus surgery 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.

Also known as: MRESS

Modified radical endoscopic sinus surgery(MRESS)

functional endoscopic sinus surgery PROCEDURE

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

Also known as: FESS

Functional endoscopic sinus surgery (FESS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zheng Liu: lead
• Wuhan Central Hospital: collaborator
• Wuhan No.1 Hospital: collaborator
• Tianyou Hospital Affiliated to Wuhan University of Science and Technology: collaborator
• Wuhan Third Hospital: collaborator
• Wuhan Pu-Ai Hospital: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Zheng Liu, Doctor

  Huazhong University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: April 21, 2021
• Study Start: December 6, 2020
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)