Comparison of outcomes of posterior nasal neurectomy with radiofrequency ablation versus bipolar diathermy in patients with intractable moderate to severe persistent allergic rhinitis – An Academic trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- SNOT22 questionnaire (sinonasal outcome test)
研究概览
简要总结
Hypothesis
Posterior nasal nerve neurectomy with radiofrequency ablation is equally efficacious as bipolar diathermy in alleviating symptoms in patients with intractable allergic rhinitis
The different modalities of treatment for allergic rhinitis include avoidance of causative allergen, interventions in the form of intranasal steroid spray and other pharmacological interventions, immunotherapy, surgical modalities. Medical management is effective in allergic rhinitis but require prolonged treatment with side effects
A subset of patients are however refractory to medical management
Immunotherapy can cause substantial financial burden as it is given for prolonged time.
Surgical treatment is indicated for patients who have inadequate response to medical management
Vidian neurectomy historically was done for refractory rhinitis and several studies revealed it is effective in reducing symptoms, but can cause side effects like dry eyes, numbness of cheeks and palate, abducens palsy, eye muscle disorders, postoperative hemorrhage
Modalities that target postganglionic posterior nasal nerve branches of vidian nerve helps reduce side effects associated with vidian neurectomy.
Different tools that can be used are radiofrequency ablation, cryoablation, bipolar diathermy, laser ablation of posterior nasal nerve
Temperature controlled radiofrequency ablation involves monitoring tissue temperature and adjusts radiofrequency current reducing excess damage to the tissue
In this study the comparison is done for outcomes of posterior nasal nerve neurectomy with radiofrequency ablation versus bipolar diathermy in patients with intractable moderate to severe persistent allergic rhinitis on which limited studies are present
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Persistent moderate to severe allergic rhinitis
- •18-60 years males and females
- •No improvement in symptoms with 3 months usage of intranasal steroid spray.
排除标准
- •Patients with gross deviated nasal septum
- •Patients with nasal polyps
- •Patients with acute rhinosinusitis
- •Patients with previous history of nose surgeries
- •Patients with previous history of radiation exposure to head and neck
- •Pregnant Women
- •Patients using oral contraceptive pills, antipsychotics
- •Patients with hypothyroidism.
结局指标
主要结局
SNOT22 questionnaire (sinonasal outcome test)
时间窗: Preoperatively, | 1 month, | 3 months, | 6 months
次要结局
- • To compare duration of surgery, intraoperative bleeding between two groups(• To compare postoperative crusting using diagnostic nasal endoscopy between two groups)
研究者
Aakash Reddy Gade
All india institute of medical sciences, mangalagiri