Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2018-09-30

Brief Summary

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Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile morbidity after total abdominal hysterectomy

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Detailed Description

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Total abdominal hysterectomy (TAH) is the most common gynecologic operation worldwide. The two most common complications after TAH are febrile and infectious morbidities, incidence varying between 5 and 50 percent. After performing TAH, vaginal canal must be breached and closed to be blind-pouch stump. Routing vaginal douching at the night before and on the morning of the surgical date, and intra-operative painting are routinely practiced. However, no good quality of evidence base supports the effectiveness of vaginal douching and painting in preventing febrile and infectious morbidities after TAH.

Conditions

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Febrile Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Factorial 2-by-2 open labeled randomised controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control-douching group

No preoperative vagina douching

Group Type NO_INTERVENTION

No interventions assigned to this group

Control-painting group

No intra-operative vagina painting

Group Type NO_INTERVENTION

No interventions assigned to this group

Vaginal douching group

Preoperative vaginal douches with povidone-iodine solution

Group Type EXPERIMENTAL

Vagina douching

Intervention Type PROCEDURE

Vaginal douches with 1000 ml of 1% povidone-iodine solution on the night before surgery and again on the morning of surgery

Vaginal painting group

Intra-operative vaginal painting with povidone-iodine solution

Group Type EXPERIMENTAL

Vagina painting

Intervention Type PROCEDURE

Vaginal painting of vagina stump after hysterectomy with 10% povidone-iodine solution 30 ml

Interventions

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Vagina douching

Vaginal douches with 1000 ml of 1% povidone-iodine solution on the night before surgery and again on the morning of surgery

Intervention Type PROCEDURE

Vagina painting

Vaginal painting of vagina stump after hysterectomy with 10% povidone-iodine solution 30 ml

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women who undergoing total abdominal hysterectomy
* Woman who agrees to participate in this study

Exclusion Criteria

* Women with history of sea-food or iodine allergy
* Women who undergo emergency TAH
* Women who have intestinal resection in this operation
* Women who have active pelvic inflammatory disease before operation
* Women who have fever before operation
* Women who received antibiotic within 1 weeks before operation
* Women who be immunocompromised host

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes