A Study to Investigate the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic Sinus Surgery (ESS).
- Who it may be relevant to
- Registry conditions: Chronic Rhinosinusitis With Nasal Polyps. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese CRSwNP Patients
Overview
This is a prospective, multicenter real-world study to describe the postoperative outcomes and quality of life, disease control and characteristics of patients who underwent surgery, as well as economic burden and post-operative treatment patterns in Chinese patients with CRSwNP recurrence.
Detailed description
This is a prospective, multicenter real-world study to describe the postoperative outcomes and quality of life, disease control and characteristics of patients who underwent surgery, as well as economic burden and post-operative treatment patterns in Chinese patients with CRSwNP. Patients will receive standard medical care as determined by the treating physician at each site and undergo scheduled clinical assessments.
Approximately 200 patients diagnosed with CRSwNP by physicians and scheduled for surgical treatment will be enrolled across 20 centres in different regions of China.
Interventions
- Procedure Endoscopic Sinus Surgery (ESS)
This is a standard of care surgical procedure performed according to clinical routine. No experimental treatment or investigational drug is administered as part of this study.
Primary outcome measures
- • The observed and change from baseline of Sino-Nasal Outcome Test (SNOT)-22 score at week-52 [Time frame: week0-52]
- • The observed and change from baseline of Modified Lund-Kennedy (MLK) score at week-52 [Time frame: week0-52]
Secondary outcome measures (12)
- Changes from baseline at each collection point: • VAS - Total sinus symptoms item [Time frame: week0-52]
- Changes in NPS from baseline at each collection point [Time frame: week0-52]
- Changes from baseline at each collection point: • VAS - Nasal blockage item [Time frame: week0-52]
- Changes from baseline at each collection point: • SNOT-22 Smell/taste Item Score [Time frame: week0-52]
- Changes from baseline at each collection point: • SNOT-22 Nasal Congestion Item Score [Time frame: week0-52]
- Changes from baseline at each collection point: • Nasal Congestion Score (NCS) [Time frame: week0-52]
- Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) Loss of Smell [Time frame: week0-52]
- Changes from baseline at each collection point: • Nasal Airway Resistance (NAR) [Time frame: week0-52]
- Pre-operative, 24-week post-operatively, and 52-week Lund-Mackay CT Scores [Time frame: week0-52]
- Changes from baseline at each collection point: • SF-36((Short Form Health Survey) [Time frame: week0-52]
- Changes from baseline at each collection point: • The Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score [Time frame: week0-52]
- Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) sleep domain [Time frame: week0-52]
Eligibility criteria
Inclusion criteria
- Participant must be 16 years of age or older, at the time of signing the informed consent.
- Participants with a documented diagnosis of CRSwNP.
- Endoscopic nasal polypectomy is performed during the screening period.
- Voluntarily participate and sign the informed consent form as described in A 3.
- No history or current psychiatric disorders, with normal cognitive functions including understanding, expression, and orientation.
Exclusion criteria
- Any significant disease or disorder that the investigator believes may place the patient at risk or may affect the study results or the patient's ability to participate in the study.
- Currently participating in an interventional study.
- Patients who are unable to independently complete questionnaires due to language barriers or mental status.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 18 centers
- Research Site — Changchun
- Research Site — Changsha
- Research Site — Chengdu
- Research Site — Guangzhou
- Research Site — Guangzhou
- Research Site — Guangzhou
- Research Site — Haikou
- Research Site — Kunming
- … and 10 more centers
Identifiers
NCT: NCT07446738 · D5242R00005