NCT01739426已完成不适用
Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Operational success according to the van Overbeek classification (yes/no)
研究概览
简要总结
The primary objective of this study is to evaluation the success of endoscopic treatment of Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of swallowing function at 12 months post-surgery.
详细描述
Our secondary objectives are:
A. To evaluate short-term (pain, fever, time to start of eating) and medium-term (weight, swallowing) post-operative parameters.
B. To evaluate the prevalence of post-operative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 12 months of follow-up
- •The patient has a Zenkers diverticulum as confirmed by a pharyngo-oesophagean transit test, regardless of van Overbeek classification
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient (or his/her person-of-trust) refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient does not read french
- •The patient is pregnant
- •The patient is breastfeeding
- •The patients has a contraindication for a treatment necessary for this study, or for general anesthesia
- •The patent has a history of complications related to hemostasis
- •The preoperative checkup indicates potential for hemostasis related problems
结局指标
主要结局
Operational success according to the van Overbeek classification (yes/no)
时间窗: 12 months
Change in Deglutition Handicap Index score
时间窗: baseline to 12 months
次要结局
- Change in Deglutition Handicap Index score(baseline to 6-8 weeks)
- Time until the patient restarts eating (hours)(Day 3)
- Change in Temperature (°C)(baseling to Day 3)
- Change in visual analog scale for pain(baseline to day 3)
- Presence/absence of post-operative complications(6-8 weeks)
- Change in weight(baseline to 12 months)
研究者
研究点 (2)
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