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This study is designed to evaluate whether the addition of nasopharyngeal lymphoid tissue ablation to full-house endoscopic sinus surgery (ESS) provides superior control of nasal mucosa inflammation compared to full-house ESS alone in patients with nasal polyps. Thirty-two adult participants will be randomly assigned to undergo either full-house ESS only or full-house ESS combined with nasopharyngeal lymphoid tissue ablation. The primary outcome will be assessed through changes in inflammatory cell profiles at 1, 3, and 6 months postoperatively. Secondary outcomes include inflammatory cytokine levels, symptom scores, endoscopic findings, polyp recurrence rates, and safety measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue Ablation | Experimental |
| |
| Full-House Endoscopic Sinus Surgery | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasopharyngeal Lymphoid Tissue Ablation | Procedure | The nasal mucosa is initially decongested using a topical vasoconstrictor. A small-caliber urethral catheter is then introduced through each nasal cavity to elevate the soft palate. A 45° rigid nasoendoscope is inserted transorally to visualize the nasopharynx. Under endoscopic guidance, the nasopharyngeal lymphoid tissue is identified on the nasopharyngeal roof. Following aspiration of any secretions, the tissue is completely resected with a plasma scalpel. |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers and Proportions of Nasal Mucosa inflammatory cells in Patients With Nasal Polyps at Baseline and 1, 3, and 6 Months After Surgery | Sampling of the ethmoid sinus mucosa from patients after surgery is performed under nasal endoscopic guidance; nasopharyngeal swabs are used to collect samples from the nasopharynx. The method for nasopharyngeal sampling is as follows: The subject sits in a seated position, blows their nose, and closes their eyes before swab sample collection to facilitate relaxation and ease of sampling. A professional doctor gently inserts the nasal swab into one nostril along the bottom of the nasal cavity (parallel to the hard palate) until it reaches the nasopharynx, then rotates the swab approximately five times in the nasopharynx. The swab is placed into a collection tube containing 2 mL of RPMI medium. One nasopharyngeal swab is collected per donor each time. After processing, flow cytometry is used for analysing the numbers and proportions of inflammatory cells (including T cells, B cells, Plasma cells, Eosinophils, and Neutrophils). | At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Cytokine Levels in Nasal Secretions Post - surgery | Detection of inflammatory cytokine levels (e.g., IL - 5, IL - 13) in nasal secretions. Samples are collected via nasal swab, then processed and analyzed using immunoassay techniques (e.g., ELISA). | At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yin Yao | Contact | 86 15071077020 | Dr.yaoyin@hotmail.com | |
| Xing-Liang Wu | Contact | 86 15131662389 | 15131662389@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| Full-House Endoscopic Sinus Surgery | Procedure | After complete removal of the nasal polyps, a full ethmoidectomy is performed, removing all bony septa within the sinuses. Conventional sphenoidotomy and frontal sinusotomy are carried out, with or without preservation of the middle turbinate. Only irreversibly polypoid mucosa is resected, while normal mucosa is preserved. |
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| Total VAS Score and Symptom - specific VAS Scores Post - surgery |
Evaluate total VAS score and individual symptoms (nasal obstruction, mucopurulent discharge, postnasal drip, headache/dizziness, facial fullness, hyposmia/anosmia, sneezing, sleep disturbance, fatigue, general discomfort). Scores are self - reported by patients using a 0 - 10 scale. |
| At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery. |
| Nasal Endoscopy Scores | Assess nasal endoscopy scores. The scoring includes signs such as nasal polyps, mucosal edema, secretions, crusting, and scarring. Trained clinicians perform nasal endoscopy at each time point following a standardized protocol and record scores based on the presence and severity of these signs. | At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery. |
| SNOT - 22 Score Changes Post - surgery | Assess quality - of - life symptoms (nasal discharge, sneezing, rhinorrhea, cough, postnasal drip, purulent discharge, smell/taste disturbance, nasal obstruction/congestion, ear fullness, dizziness, ear pain, facial pain/pressure, difficulty falling asleep, nighttime awakenings, poor sleep quality, morning fatigue, daytime fatigue, decreased work efficiency, difficulty concentrating, depression/irritability, anxiety, restlessness) via the SNOT - 22 questionnaire. | At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery. |
| Polyp Recurrence Post-surgery | Polyp recurrence assessed by nasal endoscopy. | Focus on the first 6 months post-surgery, with extended monitoring continuing up to 24 months. |
| Rate of Reoperation | Assess the proportion of patients undergoing reoperation within 6 months after surgery. Reoperation is indicated if:
| Focused on 6 months post-surgery; continued monitoring to 24 months post-surgery. |
| Postoperative Rescue Treatment Medication Use | Record rescue treatment (oral methylprednisolone: days 1-5: 30 mg, days 6-10: 20 mg, days 11-15: 10 mg, days 16-20: 5 mg) initiation for symptom/polyp recurrence. | Within 6 months post-surgery. |
| Postoperative Complications | Record postoperative complications, including bleeding, infection, and altered Sense of Smell. | Within 6 months after surgery. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |