NCT01264835终止不适用
Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy
Ethicon Endo-Surgery6 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Procedure Duration (Surgery Time)
研究概览
简要总结
This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure duration) and post-operative patient outcomes (e.g., pain)following a modified Ferguson hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy.
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
- •Are at least 18 years of age
- •Are willing to give consent and comply with evaluation and treatment schedule
- •Meet institutional criteria for excisional hemorrhoidectomy
- •Are able to understand and complete study questionnaires.
排除标准
- •Previous Hemorrhoid surgery
- •Chronic daily narcotic use
- •Chronic Nonsteroidal Anti-inflammatory Drug use two weeks prior to procedure
- •Internal hemorrhoids that may be suitable for office management (surgeon discretion)
- •Fecal or urinary incontinence
- •Inflammatory Bowel Disease (Crohns, ulcerative colitis)
- •Acutely thrombosed hemorrhoids (surgeon discretion)
- •Evidence of acute sepsis or the presence of a fistula
- •Anal stricture.
结局指标
主要结局
Procedure Duration (Surgery Time)
时间窗: Time of surgery
Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.
次要结局
未报告次要终点
研究者
研究点 (6)
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