Clinical trial NCT06108921: Efficacy and Safety of Xylitol Nasal Irrigation After Functional Endoscopic Sinus Surgery
Official title: Efficacy and Safety of Xylitol Nasal Irrigation After Functional Endoscopic Sinus Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Postoperative Care
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Taiwanese version of the 22-item Sino-Nasal Outcome Test
timeFrame: From before operation to 3 months after surgery
measure: Self-reported adverse events
timeFrame: From before nasal irrigation to after 2-month nasal irrigation
Secondary outcomes:
measure: Change of the second minimal cross-sectional area of the nasal cavity
timeFrame: From before operation to 3 months after surgery
measure: Change of endoscopic score
timeFrame: From before operation to 3 months after surgery
measure: Change of saccharine transit time
timeFrame: From before operation to 3 months after surgery
measure: Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire
timeFrame: From before nasal irrigation to after 2-month nasal irrigation
measure: Change of Eustachian Tube function by the nine-step inflation/deflation test
timeFrame: From before nasal irrigation to after 2-month nasal irrigation
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
state: None Selected
Study officials:
affiliation: Taichung Veterans General Hospital
name: Rong-San Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: