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Completed

NCT Number: NCT03537313

Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy

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

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Key information

Conditions

Febrile Morbidity

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vagina douching

Procedure

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

Vagina painting

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 25, 2018
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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