Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy

Not Applicable

Completed

• Conditions: Febrile Morbidity
• Interventions: Procedure: Vagina douching; Procedure: Vagina painting

• Registration Number: NCT03537313
• Lead Sponsor: Rajavithi Hospital

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.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-25
• Study Start: 2018-08-15
• Primary Completion: 2018-09-15
• Study Completion: 2018-09-30
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vaginal douching group	Vagina douching	Preoperative vaginal douches with povidone-iodine solution
Vaginal painting group	Vagina painting	Intra-operative vaginal painting with povidone-iodine solution

Primary Outcome Measures

Name	Time	Method
Febrile morbidity	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

Name	Time	Method
Vaginal cuff infection	2 weeks after surgery	Defined as redness, tenderness, infiltration or abscess at vaginal cuff
Other infectious morbidities	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

Trial Locations

Locations (1)

Rajavithi hospital; 🇹🇭 Bangkok, Thailand