A Randomised Controlled Trial to Compare Success and Complication Rates in Endonasal Dacryocystorhinostomy Surgery With and Without Silicone Tubes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The primary end point will be functional success, determined by patient-reported symptoms. This will be assessed a minimum of six months post-operatively. In patients with tubes these will be removed at 3 months post-operatively.
研究概览
简要总结
Aim of study is to investigate whether the use of silicone tubes in endonasal DCR surgery increases the success rate and / or complication rate compared to surgery without tubes.
详细描述
Dacryocystorhinostomy (DCR) is the treatment of choice for epiphora due to nasolacrimal duct obstruction. A passage is created between the lacrimal sac and nasal cavity by removing the layers of bone and mucosa between them. It can be performed via an external (transcutaneous) or endonasal route with equivalent success rates.[1] In order to prevent restenosis of the ostium, silicone tubes are often used to maintain the patency of the newly-created fistula. The tubes are removed between 6 weeks and 3 months post-operatively.
Problems associated with tubes include granuloma formation with secondary infection or adhesions, canalicular lacerations, allergic reaction to the silastic, and discomfort.
There are a number of reports of DCR surgery without tubes which demonstrate an equivalent success rate compared with surgery using tubes; however, these studies have been non-randomised, retrospective reviews.[2-6] The only prospective, randomised controlled study[7] had only 42 participants and did not state at which point during the surgery the randomisation was revealed; unless the allocation occurs after the ostium has been completed there is the risk of bias since the surgeon may (consciously or inadvertently) create a larger ostium in cases where no tubes are to be used.
The purpose of this study is to perform a prospective, randomised controlled study to assess whether the use of tubes affect the long-term success of DCR.
Hypothesis Silicone tubing does not improve success rate of endonasal DCR surgery.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (> 16 years) undergoing primary DCR for NLDO who have given fully informed consent to be in the trial
排除标准
- •Age less than 16 years
- •Previous ipsilateral DCR or nasal surgery
- •Canalicular disease
结局指标
主要结局
The primary end point will be functional success, determined by patient-reported symptoms. This will be assessed a minimum of six months post-operatively. In patients with tubes these will be removed at 3 months post-operatively.
时间窗: 6 months
次要结局
- The secondary end point will be anatomical success, as measured by patency of nasolacrimal irrigation at 6 months post-operatively. In patients with tubes these will be removed at 3 months post-operatively.(6 months)