Evaluating vidian neurectomy efficacy in allergic rhinitis via nasal mucosal response
| ISRCTN | ISRCTN90123716 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90123716 |
- Submission date
- 03/03/2025
- Registration date
- 06/03/2025
- Last edited
- 05/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
The primary treatments for allergic rhinitis (AR) include drug therapy, immunotherapy and surgical interventions. Vidian neurectomy (VN), a targeted surgical method, proposes severing the vidian nerve to mitigate autonomic responses that exacerbate AR symptoms. The current evaluation of VN efficacy primarily relies on subjective symptom scores from patients, lacking objective indicators. This study proposes using nasal mucosal autonomic nerve responses, measured via an opisthenar sympathetic skin response (SSR) instrument (SSR-1000, BIOPAC, CA, USA), as an objective indicator of VN efficacy. This study will validate the use of this measurement as a reliable indicator of surgical success for patients with severe AR and provide a more quantitative assessment of VN’s impact on AR symptoms.
Who can participate?
Thirty-five patients with moderate to severe AR and 35 healthy controls were included.
What does the study involve?
Patients in the experimental group underwent electrocoagulation of the VN with a low-temperature plasma knife (Coblator II, ArthroCare, USA).
What are the possible benefits and risks of participating?
Benefits: Post-VN, damage or disruption to the parasympathetic nerve fibres in the nasal mucosa leads to constriction of the nasal submucosal blood vessels and diminished glandular secretion, thus alleviating symptoms such as nasal congestion, rhinorrhoea, sneezing and nasal itching. Nasal mucosal autonomic nerve response is expected to provide a reliable, objective measure for evaluating the effectiveness of VN in treating AR.
Risks: Long term attention should be paid to the long-term efficacy and potential complications of VN.
Where is the study run from?
Yulin City First Hospital of Yan'an University, China
When is the study starting and how long is it expected to run for?
July 2022 to December 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Yan Niu, Niuyan_2024@yeah.net
Contact information
Public, Scientific, Principal Investigator
Yulin City First Hospital of Yan'an University, No. 93 Yuxi Avenue, Yuyang District
Yulin
719000
China
| Phone | +86 18891521582 |
|---|---|
| Niuyan_2024@yeah.net |
Study information
| Study design | Single-center interventional non-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Use of nasal mucosal autonomic nerve response in efficacy evaluation of vidian neurectomy for allergic rhinitis: a prospective study |
| Study objectives | To use nasal mucosal autonomic nerve responses, measured via an opisthenar sympathetic skin response (SSR) instrument (SSR-1000, BIOPAC, CA, USA), as an objective indicator of vidian neurectomy efficacy. |
| Ethics approval(s) |
Approved 01/07/2022, The Ethics Committee of Yulin City First Hospital of Yan'an University (No. 93 Yuxi Avenue, Yuyang District, Yulin, 719000, China; +86 18992275370; Llinzheng11@outlook.com), ref: [2022] Ethical Review No. (061) |
| Health condition(s) or problem(s) studied | Evaluate the use of nasal mucosal autonomic nerve responses as an objective indicator for assessing the efficacy of vidian neurectomy (VN) in treating allergic rhinitis (AR) |
| Intervention | Patients in the experimental group underwent electrocoagulation of the vidian nerve under general anaesthesia, utilising a low-temperature plasma knife (Coblator II, ArthroCare, USA). The control group consisted of 35 healthy individuals. The nasal mucosal autonomic nerve response was induced through respiratory stimulation. Measurements were conducted before and 1 month after the patients underwent low-temperature plasma VN. Electrical signals from the nasal mucosa and the back of the hand were recorded using an SSR instrument. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Waveform of nasal mucosal autonomic responses and sympathetic skin response measured using waveforms and amplitude of electrical signals before and 1 month after the patients underwent low-temperature plasma VN |
| Secondary outcome measures | The effect of comorbidities (nasal polyps, sinusitis and a deviated nasal septum) on surgery efficacy measured using the amplitude of autonomic nervous responses in the left and right nasal mucosa of patients with three types of comorbidities before and 1 month after the patients underwent low-temperature plasma VN |
| Overall study start date | 01/07/2022 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 81 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 70 |
| Key inclusion criteria | 1. Patients diagnosed with moderate to severe AR without age limitation 2. Selection adhered to the ARIA guidelines, which require AR symptoms to persist for over 4 weeks, occurring more than 4 days per week and lasting longer than 4 hours each day 3. Candidates were either unresponsive to conventional drug treatments or exhibited intolerance |
| Key exclusion criteria | 1. Any nasal surgeries within the 6 months before the study 2. Pregnancy or lactating 3. Prior medical history or conditions that could influence autonomic nerve function or inflammatory responses, such as severe cardiovascular diseases, neurological disorders or other types of rhinitis 4. A history of autoimmune disorders, such as rheumatoid arthritis 5. Use of medications affecting the autonomic nervous system within the last 3 months, such as beta-blockers or immunosuppressants |
| Date of first enrolment | 01/01/2023 |
| Date of final enrolment | 01/03/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Yulin
719000
China
Sponsor information
Hospital/treatment centre
Yulin City First Hospital of Yan'an University
No. 93 Yuxi Avenue, Yuyang District
Yulin
719000
China
| Phone | +86 18992275370 |
|---|---|
| Llinzheng11@outlook.com | |
| Website | https://www.ylsdyyy.com/ |
"ROR" |
https://ror.org/01dyr7034 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr. Yan Niu, Niuyan_2024@yeah.net |
Editorial Notes
04/03/2025: Study's existence confirmed by the Ethics Committee of Yulin City First Hospital of Yan'an University.
