Chronic rhinosinusitis with nasal polyps
Conditions
Interventions
A group:nasal endoscopic surgery, postoperative hydrogen-enriched saline nasal irrigation.
B group:nasal endoscopic surgery, postoperative saline nasal irrigation.
Sponsors
Shanghai Tongji Hospital (Tongji Hospital affiliated to Tongji University)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese citizens aged 18 or above, regardless of gender. 2. Subjects must be diagnosed with chronic sinusitis at screening and baseline follow-up (the diagnostic criteria refer to chronic sinusitis in China). Guidelines for the diagnosis and treatment of inflammation (2018), Chinese journal of otolaryngology, 2019,54(2):81-100), and Patients requiring surgical treatment. 3. The subject is in good health, without a clinically significant disease disturbing the test schedule or operation or affecting the safety of the subject.. 4. Subject shall provide written informed consent and be able to comply with medication and follow-up schedule. 5. Fertile female subjects must have negative urine HCG at screening.
Exclusion criteria
Exclusion criteria: 1. Previous history of sinus surgery. 2. Any clinical abnormality in vital signs or clinically significant abnormality in ecg results at screening or baseline follow-up Subjects. 3. Subjects with clinically significant cardiovascular, lung, kidney, liver, metabolic disease, hematological or neurological disease, or subjects with compromised immune systems. 4. Patients with fungal sinusitis or nasal and sinus tumors. 5. Subjects are members of the research team directly involved in this experiment. 6. Family planning within three months. 7. Those who have participated in clinical drug trials within three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective symptom VAS score;Evaluation of Lund-Kenenedy for nasal endoscopy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time required for complete epithelialization of the surgical cavity;Short-term efficacy evaluation; | — |
Countries
China
Contacts
Public ContactJin Ling
Department of Otolaryngology, Tongji Hospital affiliated to Shanghai Tongji University
Outcome results
None listed