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

Nasal Polyps Clinical Trial

— EMRESSECRS  

Official title:

The Effect of Modified Radical Endoscopic Sinus Surgery on Chinese Patients With Eosinopilic Nasal Polyps

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852562
• Other study ID #: ENTmodifiedRESS-01
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2020
• Est. completion date: December 6, 2024

Study information

• Verified date: July 2023
• Source: Huazhong University of Science and Technology
• Contact: Zheng Liu, Doctor
• Phone: 86 027 83663807
• Email: zhengliuent[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 6, 2024
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Sinusitis
• Endoscopic Sinus Surgery
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Procedure:
• 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.
• functional endoscopic sinus surgery
Full maxillary antrostomy, ethmoidectomy, sphenoidotomy and frontal sinusotomy, but with the middle turbinate preservation.

Locations

Country	Name	City	State
China	Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zheng Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid	Investigate the change of inflammation molecular biomarkers using sample of nasal lavage fluid or mucosal lesion tissue. Biomarkers including interleukin 9, monocyte chemoattractant protein-1, macrophage inflammatory protein-1ß, macrophage inflammatory protein-1a, chemokine (C-C motif ) ligand 17 and IgE in nasal lavage fluid at months 1, 3, 6 and 12 were detected to compare the changes of molecular indices relative to baseline.	1month, 3month, 6month, 12month
Primary	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	Revision surgery rate	The rate of reoperation in each group after surgery	12month
Secondary	Symptom duration	The time of duration of major symptoms of postoperative patients	1month, 3month, 6month, 12month
Secondary	Postoperative medication	The duration and dose of postoperative medication needed to relieve symptoms	1month, 3month, 6month, 12month
Secondary	Recurrence time	Recurrence was defined if the patient had symptoms of chronic rhinosinusitis after surgery, and nasal endoscopy found nasal polyps recurrence, obvious edema of mucosa, or purulent secretion, and above of symptoms or physical signs existed, which can't be alleviated by maximum medicine treatment at least 1 month	1month, 3month, 6month, 12month
Secondary	Change from baseline at months 1, 3, 6 and 12 in visual analogue scale (VAS) after surgical intervention	The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters (cm) VAS the answer to the question, "How troublesome are your symptoms of your rhinosinusitis?" The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome.	1month, 3month, 6month, 12month
Secondary	Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention	Endoscopic result is scored according to Lund-Kennedy system, with the assessment of nasal polyp (NP), edema, nasal discharge, scarring and crusting. Items including edema, nasal discharge, scarring and crusting score 0 for no problem, 1 for mild abnormalities and 2 for severe abnormalities. NP score is graded and based on NP size recorded as the sum of the right and left nostril scores with a range of 0-8; higher scores indicate worse status. Individual score ranges from 0 (no polyps) to 4 (large polyps causing almost complete congestion/ obstruction of the inferior meatus) within each nostril.	1month, 3month, 6month, 12month