NCT01306877已完成不适用
Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon PPH03 In A Hemorrhoidopexy Procedure (HEMOSTASIS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Intraoperative Bleeding
研究概览
简要总结
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is able to understand and sign Informed Consent Form
- •The subject is between 18-85 years of age.
- •The subject has (symptomatic) Grade 2-3 Hemorrhoids and is eligible for stapled hemorrhoidopexy
排除标准
- •The procedure is needed as revision hemorrhoid surgery.
- •Any female patient, who is pregnant, suspected pregnant, or nursing.
- •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 1 year 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 has taken aspirin, anti-coagulation and/or anti platelet therapies (e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery.
- •The participant has a history of fecal incontinence
- •The participant has had injection therapy, infrared laser treatment or rubber band ligation for treatment of hemorrhoids within 1 month of screening
- •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
Intraoperative Bleeding
时间窗: Day 0 - time of surgery
Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.
次要结局
- Post Operative Pain - (PI-NIRS)(Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180)
- Post-Operative Pain (Analgesic Intake)(Day 0, 1 week, 2 week, 1 month, 3 month, 6 month)
- Overall Quality of Life - General Health Score(Day 0 minus 60, 1 week, 1 month, 3 months, 6 months)
- Location of the Staple Line(Day 0)
- Length of Stay(Day 0 time of discharge minus time of admission)
- Operative Room (OR) Time(Day 0)
研究者
研究点 (2)
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