Clinical trial NCT06010316: A Prospective Single-center Cohort Study of Surgical Treatment of Chronic Rhinosinusitis
Official title: A Prospective Single-center Cohort Study of Surgical Treatment of Chronic Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Rhinosinusitis (Diagnosis)
Cohort Study
Evidence-based Medicine
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic sinusitis in the research ward of the Department of Rhinology, Beijing Tongren Hospital, Capital Medical University.

Brief summary: Chronic Rhinosinusitis (CRS) is a common and frequent disease in otorhinolaryngology. The main symptoms of patients include nasal congestion, runny nose, swelling pain of the frontal area and decreased sense of smell. Chronic rhinosinusitis refers to chronic rhinosinusitis with symptoms lasting ≥12 weeks and can be divided into two subgroups: chronic rhinosinusitis with and without nasal polyps. Chronic rhinosinusitis has a complex pathogenesis, there are three main pathogenic factors: infection, allergy and nasal and sinus anatomic abnormalities, these factors are often not a single existence, but often intertwined. In addition, environmental factors, genetic factors, osteitis, gastroesophageal reflux disease, respiratory ciliary system defects, systemic immune dysfunction and other secondary risk factors.

For patients with chronic sinusitis, these symptoms, such as nasal congestion, runny nose, swelling pain and decreased sense of smell, often seriously affect their quality of life, and even evolve into more serious complications as the disease progresses. At present, the conventional treatment methods mainly include drug conservative treatment and nasal endoscopic surgery. Functional nasal endoscopic sinus surgery (FESS) is the main method of further surgical treatment for patients with no obvious effect of drug treatment. In FESS, the current emphasis is on removing diseased tissue and restoring sinus drainage on the premise of preserving the normal mucosa and physiological structure of the nasal and nasal sinuses as much as possible.

Up to now, there have been many studies on surgical treatment of CRS, and the quality of the studies varies. However, in view of the postoperative efficacy and long-term prognosis of different subtypes of CRS, different treatment methods during surgery and different drug therapy regimens, our research group believes that it is necessary to accumulate a large amount of clinical data support through in-depth research and comprehensive analysis. Thus more reliable conclusions can be drawn. In this study, patients undergoing CRS surgery in the research ward of the Department of rhinosinusitis will be actively included through a prospective single-center cohort study to provide evidence for evidence-based medicine and better guide clinical rhinologists to make surgical treatment decisions for patients with chronic rhinosinusitis.


Eligibility criteria: Inclusion Criteria:

* (1) Meeting the CRS diagnostic criteria in the Chinese Guidelines for the Diagnosis and Treatment of Chronic Sinusitis (2018); (2) The effect of conservative drug treatment is not good or there are indications of surgery; (3) Good compliance, able to complete clinical observation. Compliance with guidelines

Exclusion Criteria:

* (1) The patient has conditions or co-existing diseases that may preclude the primary efficacy endpoint evaluation, such as benign or malignant tumors of the nasal cavity; (2) Clinically significant co-existing diseases that may interfere with clinical efficacy results, including but not limited to: Cystic fibrosis, eosinophilic granuloma with polyvasculitis (Churg-Strauss syndrome), granuloma with polyvasculitis (Wegener's granuloma), Young's synthesis, tuberculosis or other pathogen infection, malignancy, etc. (3) The patient had other medical or non-medical conditions that the investigator considered unsuitable for participation in the study.

Primary outcomes:
measure: The change in Total Nasal Symptom Score (TNSS).
timeFrame: Pre-operation, 1 year after surgery
Secondary outcomes:
measure: The changes in VAS score.
timeFrame: Pre-operation, 1 year after surgery
measure: The changes in SNOT-22 score.
timeFrame: Pre-operation, 1 year after surgery
measure: The changes in asthma ACQ score.
timeFrame: Pre-operation, 1 year after surgery
measure: The changes in Nasal Polyp Score (NPS) score.
timeFrame: Pre-operation, 1 year after surgery
measure: The changes in sinus CT score.
timeFrame: Pre-operation, 1 year after surgery
measure: The changes in olfactory symptom score.
timeFrame: Pre-operation, 1 year after surgery
measure: The changes of eosinophils in peripheral blood
timeFrame: Pre-operation, 1 year after surgery
measure: The changes of IgE in peripheral blood.
timeFrame: Pre-operation, 1 year after surgery
measure: The changes in biomarkers in nasal exfoliated cells and nasal secretion swabs.
timeFrame: Pre-operation, 1 year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
References: