‘IS POSTOPERATIVE NASAL PACKING ESSENTIAL AFTER FUNCTIONAL ENDOSCOPIC SINUS SURGERY?’
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. To compare the post operative nasal symptoms between the packed and unpacked side of the same patient after FESS
研究概览
简要总结
**AIM:**To assess the need of routine nasal packing after functional endoscopic sinus surgery (FESS)
OBJECTIVES:
PRIMARY OBJECTIVES:
1. To assess the difference in degree of postoperative bleeding from the packed and unpacked side of the same patient after FESS.
2. To assess the difference in degree of postoperative nasal blockage, pain and lateralized headache on the packed and unpacked side of the same patient after FESS.
3. To compare the early and late post operative nasal endoscopic findings between the packed and unpacked side of the same patient after FESS.
SECONDARY OBJECTIVE:
To suggest a protocol for determining the need for postoperative nasal packing after FESS
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Bilateral chronic rhinosinusitis with or without polyposis and a Lund-MacKay CT scan score difference of three or less between the left and right sides.
排除标准
- •a)Age less than 18 years b)Unilateral chronic rhinosinusitis / nasal polyp c)Previous history of endoscopic sinus surgery d)Severe co-morbidities eg.
- •uncontrolled systemic hypertension, uncontrolled diabetes mellitus e)Haemoglobin concentration of less than 10 mg/dl f)Abnormal blood coagulation profile g)Any immunological or systemic disease affecting the nose h)Pregnancy.
结局指标
主要结局
1. To compare the post operative nasal symptoms between the packed and unpacked side of the same patient after FESS
时间窗: 1. Post operative nasal symptoms will be evaluated everyday for one week after surgery and then on 4th and 12th post op week | 2. Post operative nasal endoscopic findings will be evaluated at 1st, 4th and 12th post op week
2. To compare the post operative nasal endoscopic findings between the packed and unpacked side of the same patient after FESS
时间窗: 1. Post operative nasal symptoms will be evaluated everyday for one week after surgery and then on 4th and 12th post op week | 2. Post operative nasal endoscopic findings will be evaluated at 1st, 4th and 12th post op week
次要结局
- 1. To calculate the amount of blood loss from each side during FESS(2. Assessment of surgical outcome)