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

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

Sponsors

Lead Sponsor: Assiut University

Source Assiut University
Brief 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.

Overall Status Completed
Start Date October 2015
Completion Date May 2016
Primary Completion Date April 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Degree of fever postoperative (c) 1 month
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Povidone-iodine solution

Arm Group Label: The povidone-iodine group

Intervention Type: Drug

Intervention Name: Normal saline solution

Arm Group Label: Normal saline group

Eligibility

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Gender: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Healthy Volunteers: No

Location
Facility: Assiut university
Location Countries

Egypt

Verification Date

July 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Assiut University

Investigator Full Name: Mohammed Khairy Ali

Investigator Title: Dr

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: The povidone-iodine group

Type: Active Comparator

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

Label: Normal saline group

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

Source: ClinicalTrials.gov