Povidone-iodine Versus Normal Saline Solution in Vaginal Cleansing in

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Postoperative Infection

Clinical Trial Details

NCT number	NCT02591251
Study type	Interventional
Source	Assiut University
Contact
Status	Completed
Phase	Phase 2
Start date	October 2015
Completion date	March 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Povidone-iodine Versus Normal Saline Solution in Vaginal Cleansing in Laparoscopy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms