EUCTR2014-000473-39-ES进行中(未招募)1 期
Randomized and prospective clinical trial about the therapeutic use of diatrizoic acid (Gastrografin®) in postoperative ileus.
Fundacio Parc Taulí0 个研究点目标入组 62 人开始时间: 2014年11月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients older than 18 years old.
- •- Postoperative ileus.
- •- Patients that have been submitted to abdominal surgery (including digestive, vascular, gynecologic or urologic procedures). Patients operated for colorectal surgery with protective ostomy.
- •- Signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 31
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •- Patients undergoing abdominal surgery that includes intestinal anastomosis without protective ostomy.
- •- Pregnancy or lactancy.
- •- Mechanical bowel obstruction.
- •- Intestinal isquemia
- •- Allergy to Gastrografin® (or other radiological contrast) or other situation detailed in the Gastrografin's datasheet that contraindicate its use.
- •- Postoperative complications that could cause paralytic ileus by themselves. (intraabdominal abscess, intraabdominal haematoma,...).
- •- Patients in whose participation in the clinical trial could cause any damage to their health (based on medical criteria)
- •- Severe renal failure
- •- Severe cardiac failure
研究者
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