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

NCT06108921 | Completed DMC

• 1 other identifier: CF19287A
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis; Postoperative Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 saccharine transit time

  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

Study Arms (2)

xylitol

EXPERIMENTAL

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

saline

PLACEBO COMPARATOR

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

Interventions

Xylitol Powder 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.

xylitol

Salt Powder 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.

saline

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, None Selected, 40705, Taiwan

Location

Study Officials

• Rong-San Jiang, MD, PhD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 31, 2023
• Study Start: February 1, 2020
• Primary Completion: February 28, 2023
• Study Completion: September 30, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years after the end of the study

Locations

TW (1)