Randomized, multi-center study of the efficacy of functional and localized endoscopic sinus surgery (FESS&LESS) for chronic rhinosinusitis with nasal polyps in adolescence

Randomized, multi-center study of the efficacy of functional and localized endoscopic sinus surgery for chronic rhinosinusitis with nasal polyps in adolescence

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200059919

Enrollment

Unknown

Registered

2022-05-13

Start date

2022-05-01

Completion date

Unknown

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic rhinosinusitis

Interventions

Adolescent-FESS group:Carry out the functional endoscopic sinus surgery

Adolescent-LESS group:Carry out the localized endoscopic sinus surgery

Adult-FESS group:Carry out the functional endoscopic sinus surgery

Eligibility

Sex/Gender

All

Age

12 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Conform to the diagnostic criteria of CRSwNP (bilateral) in EPOS2020 guideline, and diagnose chronic sinusitis with polyps on both sides; 2. 12-65 years old; Both male and female; 3. The subjects and their legal representatives signed the informed consent form to voluntarily join the study after understanding the purpose and procedure of the study, with good compliance and cooperation in follow-up.

Exclusion criteria

Exclusion criteria: 1. Have the following diseases: unilateral CRSwNP, CRSsNP, cystic fibrosis, congenital ciliary dyskinesia, nasal tumor or other obstructive injury, invasive or non-invasive fungal sinusitis, acute nasosinusitis, and those who have previously received open sinus surgery; 2. There are other serious metabolic, cardiovascular, immune, neurological, blood, digestive, endocrine, cerebrovascular or respiratory diseases that may affect the evaluation of the study results or endanger the safety of the subjects; 3. Those who have a history of mental illness, antagonistic personality, bad motivation, paranoid or other emotional or intellectual problems that may affect the informed validity of the study.

Design outcomes

Primary

Measure	Time frame
Nasal symptom VAS score;Sinusitis Quality of Life Scale -22(SNOT-22);Sinus CT Lund-Mackay score;Nasal endoscopy Lund-Kennedy score;Peripheral blood cell analysis ;Determination of cytokines in peripheral blood;Peripheral blood Peripheral blood total immunoglobulin E;Skin allergen prick test;Nasal exhaled nitric oxide;Fractional exhaled nitric oxide;JRSERC score;Eosinophil count in nasal polyps;Neutrophil count in nasal polyps;	—

Measure

Time frame

Nasal symptom VAS score;Sinusitis Quality of Life Scale -22(SNOT-22);Sinus CT Lund-Mackay score;Nasal endoscopy Lund-Kennedy score;Peripheral blood cell analysis ;Determination of cytokines in peripheral blood;Peripheral blood Peripheral blood total immunoglobulin E;Skin allergen prick test;Nasal exhaled nitric oxide;Fractional exhaled nitric oxide;JRSERC score;Eosinophil count in nasal polyps;Neutrophil count in nasal polyps;

—

Countries

China

Contacts

Public ContactJing Ye

The First Affiliated Hospital of Nanchang University

yjholly@email.ncu.edu.cn+86 13979161109

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026