Clinical trial NCT04852562: The Effect of Modified Radical Endoscopic Sinus Surgery on Eosinopilic Chronic Rhinosinusitus With Nasal Polyps
Official title: The Effect of Modified Radical Endoscopic Sinus Surgery on Chinese Patients With Eosinopilic Nasal Polyps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Sinusitis
Endoscopic Sinus Surgery
Nasal Polyps
Keywords: eosinophilic chronic rhinosinusitus with nasal polyps.
endoscopic sinus surgery
Nasal Polyps
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention
timeFrame: 1month, 3month, 6month, 12month
Secondary outcomes:
measure: Revision surgery rate
timeFrame: 12month
measure: Symptom duration
timeFrame: 1month, 3month, 6month, 12month
measure: Postoperative medication
timeFrame: 1month, 3month, 6month, 12month
measure: Recurrence time
timeFrame: 1month, 3month, 6month, 12month
measure: Change from baseline at months 1, 3, 6 and 12 in visual analogue scale (VAS) after surgical intervention
timeFrame: 1month, 3month, 6month, 12month
measure: Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention
timeFrame: 1month, 3month, 6month, 12month
Other outcomes:
measure: Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid
timeFrame: 1month, 3month, 6month, 12month
Locations:
city: Wuhan
country: China
facility: Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: