Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile morbidity after total abdominal hysterectomy

Detailed Description
-----------------
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.

Official Title
-----------------
Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy: A Factorial 2-by-2 Open-labeled Randomized Controlled Trial

Conditions
-----------------
Febrile Morbidity

Intervention / Treatment
-----------------
* Procedure: Vagina douching
* Procedure: Vagina painting


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Factorial 2-by-2 open labeled randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control-douching group<br>No preoperative vagina douching | |
| No Intervention: Control-painting group<br>No intra-operative vagina painting | |
| Experimental: Vaginal douching group<br>Preoperative vaginal douches with povidone-iodine solution | Procedure: Vagina douching<br>* Vaginal douches with 1000 ml of 1% povidone-iodine solution on the night before surgery and again on the morning of surgery<br>|
| Experimental: Vaginal painting group<br>Intra-operative vaginal painting with povidone-iodine solution | Procedure: Vagina painting<br>* Vaginal painting of vagina stump after hysterectomy with 10% povidone-iodine solution 30 ml<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Febrile morbidity | Defined as the presence of an oral temperature > 38 o C (100.4 o F) on two occasions at least 4 hours apart in the post-operative period excluding the first 24 hours | Day 1-7 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal cuff infection | Defined as redness, tenderness, infiltration or abscess at vaginal cuff | 2 weeks after surgery | 
| Other infectious morbidities | Defined by the presence of a urinary tract infection, abdominal wound infection, or pneumonitis; urinary tract infection defined as symptomatic infection with a mid-steam urine specimen showed bacterial growth > 105 bacteria/ml of urine; surgical wound infection defined as redness, tenderness, infiltration or abscess; pneumonitis defined as fever, physical and radiological findings of consolidation | 2 weeks after surgery |