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临床试验/NCT02591251
NCT02591251已完成2 期

A Comparison Between Povidone-iodine and Normal Saline Solution in Preoperative Vaginal Cleansing in Laparoscopic Surgery: a Randomized Clinical Study

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Degree of fever postoperative (c)

研究概览

简要总结

Laparoscopy is a minimally invasive method used for diagnostic and therapeutic purposes. It allows surgeons to take a look on the abdominal and pelvic organs. Diagnostic laparoscopy is usually done in an operating room under general anesthesia. The procedure takes about 25 minutes and the patients usually discharged in the same day. The laparoscopy can diagnose pelvic pathological conditions in approximately 50% of the cases. However, the laparoscopy has some complications, such as infections, hemorrhage and injuries of visceral organs.

A preoperative vaginal preparation is important to prevent the bacteria colonization in a trial to avoid postoperative infection after laparoscopic surgery. The povidone-iodine (PI) is normally used as a skin and vaginal disinfectant to prevent postoperative infections, however; it can be the cause of significant postoperative irritation.

There are many reports in the literature proved that the mechanical cleansing of the vagina, not the use of an antiseptic solution, is responsible for the efficacy of vaginal preparations. In the field of assisted reproductive technology; A study in 1992 concluded that the infection rates with normal saline solution are comparable to PI.

Another proved that, a normal saline solution can be effective in prevention of preventing postoperative infections after vaginal surgery.

The most recent study by Lewis et al has been shown that the Baby shampoo is preferable than PI in vaginal cleansing before gynecologic procedures because it has minimal vaginal irritation and cheaper than PI.

So the optimal vaginal antiseptic solution is unknown, the investigators want to conduct a randomized trial comparing 2 commonly used vaginal antiseptic solutions: PI and the saline solution before the laparoscopic surgery.

The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 1 - All women who will subject to laparoscopy (diagnostic or operative) for gynecological problems

排除标准

  • 1 - All women who will subjected to operative laparoscopy for myomectomy or hysterectomy.
  • 2- All patients have current vaginitis or urinary tract infection before the laparoscopy.
  • 3- Diabetic women. 4- Women with BMI > 25 kg/m2.

研究组 & 干预措施

The povidone-iodine group

Active Comparator

The patients will be subjected to povidone-iodine (Betadine7.5%, Phama Care) for vaginal cleaning before the laparoscopic surgery

干预措施: Povidone-iodine solution (Drug)

Normal saline group

Active Comparator

The patients will be subjected to normal saline solution (Sod. Chloride 0.9%, Nile) for vaginal cleaning before the laparoscopic surgery.

干预措施: Normal saline solution (Drug)

结局指标

主要结局

Degree of fever postoperative (c)

时间窗: 1 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Dr

Assiut University

研究点 (1)

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