Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases
研究概览
详细说明
Aim - To investigate the efficacy of super-oxidized solution (SOS) over normal saline in peritonitis. The investigators objectives are to present the potential clinical impact of intraperitoneal lavage with solutions for early recovery of the patient by reducing the infection rate.
Methods - A double-blind random clinical trial was performed in 240 patients diagnosed as peritonitis at MMIMSR, Mullana, Ambala, India, from December 2014 - November 2015. Subjects were divided into 2 groups, i.e. 120 patients in the study group and 120 cases in the control group. Both the groups underwent peritoneal lavage ; the study group received SOS where as control group underwent normal saline lavage. The effectiveness of both the solutions were compared.
研究类型
注册 (实际的)
阶段
- 阶段2
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
- gastric, duodenal, ileal perforation, appendicitis
- those patients were willing to participate and the informed consent was taken
Exclusion criteria:
- evidence of enteric encephalopathy
- liver diseases
- renal diseases
- heart disease
- known allergy to any substance
- multiple trauma or organ injury
- any gynaecological etiology
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Super Oxidized Solution
Procedure/Surgery: Super Oxidized Solution(SOS) in group I - SOS with normal saline solution was used
|
Two groups were made as group I and group II.
Peritoneal Lavage was given with SOS and normal saline in group I. in group II only normal saline wash was given.
其他名称：
|
|
其他：normal saline
Procedure/Surgery: normal saline In group II - patients underwent normal saline wash and bacterial load was noted. |
Two groups were made as group I and group II.
Peritoneal Lavage was given with SOS and normal saline in group I. in group II only normal saline wash was given.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the investigators measured the infection rate by checking the bacterial load during after surgery
大体时间：average of one year
|
The investigators asked about the infection, early recovery
|
average of one year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds
大体时间：With in 10 -20 days
|
the condition of the patient measured in the form of early bowel sounds, fever and discharge from the operated area
|
With in 10 -20 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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