Comparison of Outcomes of Partial Turbinectomy Versus Mucosal Diathermy in Patients With Inferior Turbinate Hypertrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Rate of Nasal Obstruction
研究概览
简要总结
Objectives: To compare the outcomes of partial turbinectomy versus mucosal diathermy in patients with inferior turbinate hypertrophy.
Methodology: The ENT Department at Sheikh Zayed Hospital in Lahore carried out this non-randomized controlled study. Total 60 adults between the ages of 18 and 60 who have been diagnosed with inferior turbinate hypertrophy were included. Septal deviation, or other major sinonasal diseases; uncontrolled allergic rhinitis; prior nasal or turbinate surgery were excluded. In group A patients partial inferior turbinectomy (PIT) was done while in group B, submucosal diathermy (SMD) was done. A 10-point Visual Analogue Scale (VAS) was used to measure nose pain on the first postoperative day and at the one-month follow-up. Nasal obstruction scores (Grades 0-3) were assessed both before and after surgery at one and three months. Using Lund and Kennedy's standardized grading method, nasal crusting was assessed. At three-month follow-up visits, tissue healing quality was evaluated.
详细描述
Study design: Randomized controlled trail Study Setting: Department of Otolaryngology, Sheikh Zayed Hospital Lahore. Study duration: Six months after approval of synopsis. Sampling technique: Non-probability consecutive sampling technique. Sample size: A sample size of 58 (29 in each group) is calculated by assuming the proportion of good healing 60% for PIT and 84% for SMD taking confidence interval of 95%, and power 80%. (8) It was calculated using OpenEpi.com.
Sample selection
Inclusion Criteria:
- Adults aged 18 to 60 years.
- Confirmed diagnosis of inferior turbinate hypertrophy.
- Persistent nasal obstruction symptoms for over 6 months.
- Inadequate response to conservative medical treatments like intranasal corticosteroids and antihistamines for at least 3 months.
Exclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Confirmed diagnosis of inferior turbinate hypertrophy.
- •Persistent nasal obstruction symptoms for over 6 months.
- •Inadequate response to conservative medical treatments like intranasal corticosteroids and antihistamines for at least 3 months
排除标准
- •• Causes of nasal obstruction other than nasal polyps, septal deviation, sinusitis, or other major sinonasal diseases.
- •Uncontrolled allergic rhinitis or undergoing immunotherapy.
- •Previous nasal or turbinate surgery.
- •Systemic diseases affecting nasal mucosa such as Wegener's granulomatosis, sarcoidosis, or cystic fibrosis.
- •Pregnancy or breastfeeding.
- •Bleeding disorders or use of anticoagulant therapy.
- •Inability to adhere to the study protocol or cognitive impairments affecting understanding and compliance
研究组 & 干预措施
partial turbinectomy
干预措施: partial turbinectomy (Procedure)
mucosal diathermy
干预措施: submucosal diathermy (Procedure)
结局指标
主要结局
Rate of Nasal Obstruction
时间窗: one month
Incidence of Nasal Pain
时间窗: one month
Rate of Nasal Crusting
时间窗: one month
次要结局
未报告次要终点
研究者
Dr Mudassar Saeed Pansota
clinical professor
Shahida Islam Medical Complex