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Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537313
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

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

Condition or disease Intervention/treatment Phase
Febrile Morbidity Procedure: Vagina douching Procedure: Vagina painting Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Factorial 2-by-2 open labeled randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy: A Factorial 2-by-2 Open-labeled Randomized Controlled Trial
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : September 15, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Hysterectomy

Arm Intervention/treatment
No Intervention: Control-douching group
No preoperative vagina douching
No Intervention: Control-painting group
No intra-operative vagina painting
Experimental: Vaginal douching group
Preoperative vaginal douches with povidone-iodine solution
Procedure: Vagina douching
Vaginal douches with 1000 ml of 1% povidone-iodine solution on the night before surgery and again on the morning of surgery

Experimental: Vaginal painting group
Intra-operative vaginal painting with povidone-iodine solution
Procedure: Vagina painting
Vaginal painting of vagina stump after hysterectomy with 10% povidone-iodine solution 30 ml




Primary Outcome Measures :
  1. Febrile morbidity [ Time Frame: Day 1-7 after surgery ]
    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


Secondary Outcome Measures :
  1. Vaginal cuff infection [ Time Frame: 2 weeks after surgery ]
    Defined as redness, tenderness, infiltration or abscess at vaginal cuff

  2. Other infectious morbidities [ Time Frame: 2 weeks after surgery ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537313


Locations
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Thailand
Rajavithi hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT03537313    
Other Study ID Numbers: RJVAG001
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fever
Body Temperature Changes