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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Rhinosinusitis Postoperative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Xylitol Powder

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Salt Powder

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No