NCT00571129Unknown不适用
Recovery After Endoscopic Dacryocystorhinostomy
Kuopio University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2004年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C.
研究概览
简要总结
Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR is still controversial. We conducted a prospective, randomized study in order to evaluate 1) the necessity of bicanalicular silicone tubes after primary EN-DCR, 2) efficacy of the perioperative Mitomycin C for the prevention of adheesion and re-stenosis of rhinostomy site in revision EN-DCR, 3) the subjective symptoms and QoL changes before and after DCR-operation.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age > 18), ASAI-III, and were scheduled for primary or revision lacrimal pathway surgery due to recurrent or chronic watering eyes or conjunctival discharge.
- •Patients were excluded if they had previous nasolacrimal surgery, malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
排除标准
- •Malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.
结局指标
主要结局
The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C.
时间窗: 5 years
次要结局
- The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation.(5 years)
研究者
Juha Seppa
PhD
Kuopio University Hospital
研究点 (2)
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