Silastic Sheet Usefulness Following Septoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in NOSE score 1 month postoperatively
研究概览
简要总结
This study aimed to evaluate the effectiveness of silastic septal splint in reducing the rates of complications, decreasing the post-operative pain, and improving satisfaction in comparison to quilting suturing technique.
Methods:
A single center randomized controlled trial, including adult above the age of 18. A total of 50 participants who underwent septoplasty were enrolled and randomly assigned into two groups, Silastic group (n=25), and quilting group (n=25). Nasal obstruction severity was assessed by using an Arabic validated version of NOSE score, preoperatively then 3 days, one week and one month postoperatively. Post-operative complications were assessed at outpatient clinic 1 week and 1 month postoperatively. Pain was assessed by a 10-point numerical scales via phone call on the 3rd day postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥ 18 years) healthy individuals of both genders with deviated nasal septum and no other concomitant procedures.
排除标准
- •Concomitant procedure other than septoplasty.
- •Previous history of septal or nasal surgery.
- •Presence of nasal polyps, chronic sinusitis or other regional pathology.
- •Bleeding disorders or anticoagulation therapy.
研究组 & 干预措施
Silastic group
included patients who underwent nasal septoplasty followed by insertion of silastic intranasal splint
干预措施: Septoplasty surgery (Procedure)
Quilting group
included patients who underwent septoplasty followed by quilting suture (Septal through and through suture)
干预措施: Septoplasty surgery (Procedure)
结局指标
主要结局
Change in NOSE score 1 month postoperatively
时间窗: 1 month postoperatively
NOSE change = preoperative NOSE - 1 month postoperative NOSE
次要结局
- Validated NOSE score(NOSE score preoperatively, 3 days, 1 week and 1 month postoperatively)
- complications(1 month)
- postoperative pain(at 3 days postoperative)
- general satisfaction questionnaire(at 1 month postoperative)
研究者
Leen Hijazi
Medical intern
King Abdulaziz Medical City