NCT02579330Unknown不适用
Randomized Controlled Trial on Practicability of Coloshield in Transanal and Anal Surgery
Daniel Steinemann, MD2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年12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
- 22
- 试验地点
- 2
- 主要终点
- Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3).
研究概览
简要总结
In various transanal and anal procedures it is desirable to clean the operating field from stool contamination. Thus mechanical bowel preparation is not well tolerated by patients. Enema does not provide sufficient effect. By the use of Coloshield a rectal washout might be performed and enable a clean operating field. In this randomized controlled trial the macroscopic contamination of the rectum with and without Coloshield is compared using the Boston Bowel Preparation Score (0-3).
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 (Outcomes Assessor)
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
- •Patients undergoing surgery for Fistula-in-ano, transanal resection of rectal Polyp or Adenoma, haemorrhoids or anal fissure.
排除标准
- •Age <18 years
- •inability to give informed consent
- •pregnancy
- •missing informed consent
- •emergency Operation (<24hours of diagnosis and admission at emergency room)
- •rectal strictures or Stenosis
- •status post rectal resection or pelvic Radiation therapy
- •inflammatory bowel disease with inclusion of the rectum
- •need for mechanical bowel preparation
结局指标
主要结局
Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3).
时间窗: during initial surgery
次要结局
- Stable position of Coloshield(during initial surgery)
- Postoperative pain (VAS-score)(during hospitalisation (48h))
- Injuries of the rectal mucosa(during initial surgery)
研究者
Daniel Steinemann, MD
Sponsor-Investigator
Cantonal Hosptal, Baselland
研究点 (2)
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