Efficacy and Safety of Xylitol Nasal Irrigation After Functional Endoscopic Sinus Surgery: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Self-reported adverse events
研究概览
简要总结
Investigators tried to evaluate the efficacy and safety of xylitol nasal irrigation as an adjuvant therapy after FESS, particularly the influence of nasal irrigation on Eustachian tube function.
详细描述
In this study, patients with chronic rhinosinusitis who received FESS were recruited and randomly assigned to 2 groups at one month post-surgery. Patients in the xylitol group received 400ml of 5% xylitol nasal irrigation daily for 2 months, and those in the normal saline (NS) group received 400ml of NS nasal irrigation daily for 2 months. Before FESS as well as before and after nasal irrigation, sino-nasal symptoms were assessed by a 22-item Sino-Nasal Outcome Test questionnaire and patients received endoscopic examination, nasal function tests, cytokine measurement of nasal irrigant, and bacterial culture from the middle meatus. The safety of nasal irrigation was assessed by self-reported adverse events, blood test, Eustachian Tube Dysfunction Patient Questionnaire and Eustachian tube function test. This study tried to evaluate the efficacy and safety of xylitol nasal irrigation as an adjuvant therapy after FESS, particularly the influence of nasal irrigation on Eustachian tube function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic rhinosinusitis who failed medical treatment
- •Patients underwent bilateral primary functional endoscopic sinus surgery.
排除标准
- •Patients with a history of immunodeficiency
- •Patients with a history of sinus surgery
- •Patients who receiving antibiotic treatment within a week before functional endoscopic sinus surgery
- •Patients with a pathological diagnosis of fungal sinusitis
- •Patients with a pathological diagnosis of sinonasal tumor
研究组 & 干预措施
xylitol
In the xylitol group, 5% xylitol solutions were first prepared by mixing two packs of 10 mg xylitol powder with 400 mL of sterile water in the container of the irrigator. Nasal irrigation was performed by using a Sanvic SH903 pulsatile irrigator (Yun-Wang Industrial Co., Tainan, Taiwan). When irrigating the nose, patients irrigated both of their nasal cavities each with 200 mL of solutions once a day. Patients performed nasal irrigations for 2 months.
干预措施: Xylitol Powder (Drug)
saline
In the saline group, the normal saline solution was prepared by mixing 2 packs of 1.8 mg salt powder with 400 mL of sterile water in the container of the irrigator. Nasal irrigation was performed by using a Sanvic SH903 pulsatile irrigator (Yun-Wang Industrial Co., Tainan, Taiwan). When irrigating the nose, patients irrigated both of their nasal cavities each with 200 mL of solutions once a day. Patients performed nasal irrigations for 2 months.
干预措施: Salt Powder (Drug)
结局指标
主要结局
Self-reported adverse events
时间窗: From before nasal irrigation to after 2-month nasal irrigation
Any adverse events occurring during the 2 months period of nasal irrigation
Taiwanese version of the 22-item Sino-Nasal Outcome Test
时间窗: From before operation to 3 months after surgery
The Taiwanese version of the 22-item Sino-Nasal Outcome Test contains 22 items of symptoms and social/emotional consequences from nasal disorder. Patients are asked to rate their problems based on how they have been over the past two weeks. Each item is graded from 0 (no problem) to 5 (as bad as it can be) according to its severity and frequency.
次要结局
- Change of saccharine transit time(From before operation to 3 months after surgery)
- Change of the second minimal cross-sectional area of the nasal cavity(From before operation to 3 months after surgery)
- Change of endoscopic score(From before operation to 3 months after surgery)
- Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire(From before nasal irrigation to after 2-month nasal irrigation)
- Change of Eustachian Tube function by the nine-step inflation/deflation test(From before nasal irrigation to after 2-month nasal irrigation)