Chronic Rhinosinusitis
Conditions
Keywords
Nasal Irrigation, Povidone-Iodine, Endoscopic Sinus Surgery, Mucomyst, Chronic Rhinosinusitis, povidone-iodine ototoxicity
Brief summary
This prospective randomized controlled trial evaluates the effectiveness and safety of different nasal irrigation solutions for postoperative care after endoscopic sinus surgery in patients with chronic rhinosinusitis. Patients undergoing endoscopic sinus surgery will be randomly assigned to receive nasal irrigation with normal saline, mucomyst, or diluted povidone-iodine solution for three months after surgery. Clinical outcomes, symptom scores, endoscopic findings, and potential ototoxic effects will be evaluated to compare the effectiveness and safety of these irrigation methods.
Detailed description
Chronic rhinosinusitis is a common inflammatory disease characterized by symptoms such as nasal obstruction, nasal discharge, facial pressure, and decreased sense of smell. Endoscopic sinus surgery (ESS) is often performed in patients whose symptoms do not improve with medical treatment. Postoperative nasal irrigation is widely used to promote mucosal healing and remove secretions in the nasal cavity and paranasal sinuses. Povidone-iodine has broad-spectrum antimicrobial activity and is commonly used as a disinfectant. It has been suggested that diluted povidone-iodine solution may improve postoperative wound healing and provide additional antimicrobial effects when used as a nasal irrigation solution. However, concerns exist regarding the potential ototoxicity of povidone-iodine if it enters the middle ear during irrigation. This prospective randomized controlled trial aims to evaluate the effectiveness and safety of nasal irrigation using normal saline, mucomyst, or diluted povidone-iodine solution after endoscopic sinus surgery in patients with chronic rhinosinusitis. Patients will receive nasal irrigation for three months after surgery. Clinical outcomes, symptom scores, endoscopic findings, and hearing-related tests including pure tone audiometry, tympanometry, and distortion product otoacoustic emissions will be evaluated to assess treatment effectiveness and potential ototoxicity.
Interventions
Postoperative nasal irrigation using normal saline solution for 3 months after endoscopic sinus surgery.
DRUGAcetylcysteine (Mucomyst) Nasal Irrigation
Postoperative nasal irrigation using acetylcysteine solution for 3 months after endoscopic sinus surgery.
DRUGPovidone-Iodine Nasal Irrigation
Postoperative nasal irrigation using diluted 0.5% povidone-iodine solution for 3 months after endoscopic sinus surgery.
Sponsors
Pusan National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients diagnosed with chronic rhinosinusitis * Patients who underwent endoscopic sinus surgery (ESS) * Patients who performed postoperative nasal irrigation for 3 months * Patients who completed the follow-up evaluation and agreed to participate in the study
Exclusion criteria
* History of chronic otitis media * Presence of otitis media with effusion at the time of evaluation * History of previous middle ear surgery * Known allergy to povidone-iodine * Incomplete follow-up data * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lund-Kennedy Endoscopic Score | 3 months after endoscopic sinus surgery | Postoperative sinonasal status evaluated by nasal endoscopy using the Lund-Kennedy endoscopic scoring system. |
| Hearing function assessed by pure tone audiometry (PTA) | 3 months after endoscopic sinus surgery | Assessment of hearing threshold to evaluate potential ototoxicity of nasal irrigation solutions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sino-Nasal Outcome Test (SNOT-20) score | 3 months after endoscopic sinus surgery | Patient-reported sinonasal symptoms and disease-specific quality of life assessed using the Sino-Nasal Outcome Test-20 questionnaire. |
| Distortion Product Otoacoustic Emission (DPOAE) | 3 months after endoscopic sinus surgery | Assessment of hearing threshold to evaluate potential ototoxicity of nasal irrigation solutions. |
Countries
South Korea
Outcome results
None listed