Clinical Control Study of Application of Nasal Stent and Merocel Sponge After Nasal Septoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Effective rate of packing
研究概览
简要总结
Comparative study of nasal stents and nasal packing in patients undergoing septoplasty
详细描述
To investigate the safety and effectiveness of nasal stent in clinical application by comparing and observing the clinical effect and comfort of nasal stent and merocel sponge applied in nasal septoplasty. Methods: patients with nasal septal deviation were selected and randomly divided into nasal stent group (experimental group) and merocel sponge group (control group) according to the packing method. The hemostasis effect, comfort and complications of the two groups were compared during the packing period.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects voluntarily participate in the experiment and sign the informed consent;
- •Age range from 18 to 70 years old, gender unlimited;
- •With nasal congestion as the chief complaint, CT of sinus suggested deviation of nasal septum with indications of surgery (deviation of nasal septum affects breathing and nasal congestion is serious; High nasal septum deviation affects sinus drainage or causes reflex headache; Nasal septum spine often causes nasal bleeding; Nasal septum deviation affects eustachian tube function);
- •No history of respiratory tract infection and nasal decongestant use within 1 month before the visit;
- •No other treatment was used;
- •ASA grade 1~2;
- •Able to communicate well with researchers and follow the requirements of the experiment.
排除标准
- •There are acute and chronic rhinosinusitis, nasal polyps, benign and malignant tumors and other nasal diseases;
- •History of craniocerebral and nasal surgery;
- •The results of preoperative coagulation function test exceeded 20% of the upper limit of normal value;
- •Patients known to be allergic to test instrument materials;
- •Pregnant or lactating women;
- •Other organoplastic or functional diseases complicated by the subjects limited their participation in the study and could not comply with the follow-up or affect the scientific integrity of the study;
- •Participants who have participated in other clinical trials within the last 1 month;
- •Participants considered unsuitable for this clinical trial for other reasons.
结局指标
主要结局
Effective rate of packing
时间窗: 2days after operation
(1) In the period of nasal tamponade and after the removal of the tamponade instrument (48 h ± 1 h after surgery), the nasal bleeding score was ≤ 2 points; (2) 48 h ± 1 h after the completion of nasal tamponade, the overall discomfort score ≤ 7 points; (3) No septal hematoma and nasal adhesions were confirmed by nasal endoscopy at 30 days ± 5 days after the operation. Nasal tamponade is considered effective when the above 3 criteria are met.
次要结局
- visual analog scale（VAS）of comfort(2days after operation)
- security(30days after operation)