NCT01169311已完成不适用
A Prospective, Multi-Center Investigation Of The Safety And Performance Of The Covidien EEA™ Hemorrhoid And Prolapse Stapling Set With DST Series™ Technology Im A Hemorrhoidopexy Procedure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Uneventful Creation of a Functional Staple Line at First Firing of Device
研究概览
简要总结
Trial Objectives
The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set:
overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign Informed Consent Form
- •The participant must be 18-80 years of age.
- •The participant has (symptomatic) Grade 2-4 Hemorrhoids and is eligible for stapled hemorrhoidopexy.
排除标准
- •The procedure is needed as revision hemorrhoid surgery.
- •The participant is pregnant.
- •The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
- •The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
- •The participant has a history of drug or alcohol abuse.
- •The participant has a history of venous thrombosis or pulmonary embolism.
- •The participant has a history of coagulopathy.
- •The participant is taking aspirin, anti-coagulation and/or anti platelet therapies (e.g.: Warfarin, Levonox) within the last 7 days prior to the planned surgery date
- •The participant has a history of fecal incontinence.
- •The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.
结局指标
主要结局
Uneventful Creation of a Functional Staple Line at First Firing of Device
时间窗: about 20 minutes for procedure
Successful creation of staple line at first firing of device during hemorrhoidopexy
次要结局
- Intra-Operative Bleeding Requiring Intervention(Day 0 - time of surgery)
- Post Operative Pain(baseline, 30 days post op)
- Time to Return to Normal Activity(30 days post op)
- Length of Stay(Day 0, time of discharge minus time of admission)
- OR Time(Day 0 - Time of stop minus time of start)
- Quality of Life, Physical Component(baseline, 30 days post op)
- Incidence of Stapler Malfunction or Misfires(about 20 minutes for procedure)
- Quality of Life, Mental Component(Baseline, 30 days post op)
研究者
研究点 (1)
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