临床试验/NCT02790177

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: 2016年6月3日

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

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

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

发起方

Services Institute of Medical Sciences, Pakistan

申办方类型

Other Gov

责任方

Principal Investigator

主要研究者

Usman Ismat Butt

Senior Registrar

Services Institute of Medical Sciences, Pakistan

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