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

Chronic Rhinosinusitis Clinical Trial

Official title:

Efficacy and Safety of Xylitol Nasal Irrigation After Functional Endoscopic Sinus Surgery: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06108921
• Other study ID #: CF19287A
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: September 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients with chronic rhinosinusitis who failed medical treatment

2. Patients underwent bilateral primary functional endoscopic sinus surgery.

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Postoperative Care

Intervention

Drug:
• Xylitol Powder
The bilateral nasal cavity was irrigated by using a Sanvic SH903 pulsatile irrigator containing 400 ml of xylitol solution once a day for 2 months.
• Salt Powder
The bilateral nasal cavity was irrigated by using a Sanvic SH903 pulsatile irrigator containing 400 ml of normal saline once a day for 2 months.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taiwanese version of the 22-item Sino-Nasal Outcome Test	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.	From before operation to 3 months after surgery
Primary	Self-reported adverse events	Any adverse events occurring during the 2 months period of nasal irrigation	From before nasal irrigation to after 2-month nasal irrigation
Secondary	Change of the second minimal cross-sectional area of the nasal cavity	The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.	From before operation to 3 months after surgery
Secondary	Change of endoscopic score	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.	From before operation to 3 months after surgery
Secondary	Change of saccharine transit time	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.	From before operation to 3 months after surgery
Secondary	Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire	Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian tube function	From before nasal irrigation to after 2-month nasal irrigation
Secondary	Change of Eustachian Tube function by the nine-step inflation/deflation test	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'.	From before nasal irrigation to after 2-month nasal irrigation