Chronic Rhinosinusitis, Postoperative Care
Conditions
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.
Interventions
DRUGXylitol 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.
DRUGSalt 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.
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Taiwanese version of the 22-item Sino-Nasal Outcome Test | 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. |
| Self-reported adverse events | From before nasal irrigation to after 2-month nasal irrigation | Any adverse events occurring during the 2 months period of nasal irrigation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of saccharine transit time | 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. |
| Change of the second minimal cross-sectional area of the nasal cavity | From before operation to 3 months after surgery | The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry. |
| Change of Eustachian Tube function by the nine-step inflation/deflation test | 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'. |
| Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire | From before nasal irrigation to after 2-month nasal irrigation | Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian tube function |
| Change of endoscopic score | 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. |
Countries
Taiwan
Outcome results
None listed