Comparative Evaluation of Intra-operative Peritoneal Lavage With Super Oxidized Solution and Normal Saline in Peritonitis Cases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 主要终点
- the investigators measured the infection rate by checking the bacterial load during after surgery
研究概览
简要总结
Super Oxidized Solution (SOS) was used in peritonitis and results were compared by using normal saline solution in two groups. Abdominal fluid was taken to check for bacterial load after giving lavage with SOS solution and in other group normal saline. SOS is a high level disinfectant, non-flammable and no special training is required to handle it.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Day 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gastric, duodenal, ileal perforation, appendicitis
- •those patients were willing to participate and the informed consent was taken
排除标准
- •evidence of enteric encephalopathy
- •liver diseases
- •renal diseases
- •heart disease
- •known allergy to any substance
- •multiple trauma or organ injury
- •any gynaecological etiology
结局指标
主要结局
the investigators measured the infection rate by checking the bacterial load during after surgery
时间窗: average of one year
The investigators asked about the infection, early recovery
次要结局
- The Results Were Measured In the Form of the, Early Recovery, Early Bowel Sounds(With in 10 -20 days)
研究者
DR RIKKI SINGAL
Professor
Maharishi Markendeswar University (Deemed to be University)