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NCT Number: NCT06108921

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

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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Key information

Conditions

Chronic Rhinosinusitis Postoperative Care

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, None Selected, 40705, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Taiwanese version of the 22-item Sino-Nasal Outcome Test

    Time frame: 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.

  2. Self-reported adverse events

    Time frame: From before nasal irrigation to after 2-month nasal irrigation

    Any adverse events occurring during the 2 months period of nasal irrigation

Secondary outcomes

  1. Change of the second minimal cross-sectional area of the nasal cavity

    Time frame: From before operation to 3 months after surgery

    The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.

  2. Change of endoscopic score

    Time frame: 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.

  3. Change of saccharine transit time

    Time frame: 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.

  4. Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire

    Time frame: From before nasal irrigation to after 2-month nasal irrigation

    Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian tube function

  5. Change of Eustachian Tube function by the nine-step inflation/deflation test

    Time frame: 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'.

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2023
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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