NCT02790177Unknown3 期
Is Hyaluronic Acid Effective in the Prevention of Post-operative Adhesion?
Services Institute of Medical Sciences, Pakistan0 个研究点目标入组 150 人开始时间: 2016年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 主要终点
- POST OPERATIVE ADHESIONS TO BE EVALUATED BY LAPAROSCOPY AT THREE MONTHS INTERVAL
研究概览
简要总结
The objective of study is to determine the effect of hyaluronic acid on the formation of post-operative adhesions. It will be a randomized control trial comparing the product against normal saline.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consenting patients between the ages of 12-80, who undergo exploratory laparotomy and stoma formation
排除标准
- •Previous history of abdominal surgery History of peritoneal dialysis Patients in whom permanent stoma is formed
研究组 & 干预措施
HiB
Experimental
This group will receive the compound for the reduction of adhesions
干预措施: Hyaluronic Acid (Drug)
Normal saline
Placebo Comparator
This group will just receive normal saline to ensure blinding.
干预措施: NORMAL SALINE (Drug)
结局指标
主要结局
POST OPERATIVE ADHESIONS TO BE EVALUATED BY LAPAROSCOPY AT THREE MONTHS INTERVAL
时间窗: 3 months
次要结局
未报告次要终点
研究者
Usman Ismat Butt
Senior Registrar
Services Institute of Medical Sciences, Pakistan
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