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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Care; Chronic Rhinosinusitis
• Intervention / Treatment: Drug: Xylitol Powder; Drug: Salt Powder

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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • None Selected
    • Taichung, None Selected, Taiwan, 40705
      • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: Rong-San Jiang, MD, PhD, Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CF19287A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Outcome measures
• IPD Sharing Time Frame: 2 years after the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Study Data/Documents

1. Study Protocol
   Information comments: Study Data/Document can be requested from the PI.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No