Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy

Febrile Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03537313
• Other study ID #: RJVAG001
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: May 2018
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 30, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Febrile Morbidity
• Fever

Intervention

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

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vaginal cuff infection	Defined as redness, tenderness, infiltration or abscess at vaginal cuff	2 weeks after surgery
Secondary	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