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

NCT02591251 | Completed Phase 2

• 1 other identifier: VCL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Infection

Outcome Measures

Primary Outcomes (1)

• Degree of fever postoperative (c)

  1 month

Study Arms (2)

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

Drug: Povidone-iodine solution

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.

Drug: Normal saline solution

Interventions

Povidone-iodine solution DRUG

The povidone-iodine group

Normal saline solution DRUG

Normal saline group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)