Efficacy and Safety of Xylitol Nasal Irrigation After Functional Endoscopic Sinus Surgery

Not Applicable

Completed

• Conditions: Chronic Rhinosinusitis; Postoperative Care
• Interventions: Drug: Salt Powder; Drug: Xylitol Powder

• Registration Number: NCT06108921
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

1. Patients with chronic rhinosinusitis who failed medical treatment
2. Patients underwent bilateral primary functional endoscopic sinus surgery.

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Exclusion Criteria

1. Patients with a history of immunodeficiency
2. Patients with a history of sinus surgery
3. Patients who receiving antibiotic treatment within a week before functional endoscopic sinus surgery
4. Patients with a pathological diagnosis of fungal sinusitis
5. Patients with a pathological diagnosis of sinonasal tumor

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	Salt Powder	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.
xylitol	Xylitol Powder	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.

Primary Outcome Measures

Name	Time	Method
Self-reported adverse events	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	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.

Secondary Outcome Measures

Name	Time	Method
Change of saccharine transit time	From before operation to 3 months after surgery	The saccharine transit test involved placing saccharine granules under the head of the inferior turbinate in the more severely affected nostril. The time interval (minute) between placement of saccharine granules and sensation of sweetness in the throat was recorded.
Change of the second minimal cross-sectional area of the nasal cavity	From before operation to 3 months after surgery	The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.
Change of endoscopic score	From before operation to 3 months after surgery	The endoscopic appearances were categorized into polyps (0: no polyps; 1: polyps present within the middle meatus; 2: polyps beyond the middle meatus); nasal secretion (0: no secretion; 1: clear, thin secretion; 2: thick, purulent secretion); mucosal edema; scarring; crusting; (0: absent; 1: mild; 2: severe). The score ranged from 0 to 20 for both nostrils together.
Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire	From before nasal irrigation to after 2-month nasal irrigation	Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian tube function
Change of Eustachian Tube function by the nine-step inflation/deflation test	From before nasal irrigation to after 2-month nasal irrigation	Failure to alter the pressure of middle ear at least 10 daPa with swallowing during any of the steps was considered ETD (tuba1 function was 'Poor'). If the equilibration was successful (observed pressure change \>10 daPa) in all steps, Eustachian tube function was considered 'Good'.

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, None Selected, Taiwan