Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy

Department of Medical Services Ministry of Public Health of Thailand300 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

300

Conditions

Febrile Morbidity

Interventions

Vagina douchingPROCEDURE

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

Vagina paintingPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rajavithi hospital

Bangkok, Thailand

Outcomes

Primary Outcomes

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

Time frame: Day 1-7 after surgery

Secondary Outcomes

Vaginal cuff infection

Defined as redness, tenderness, infiltration or abscess at vaginal cuff

Time frame: 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

Time frame: 2 weeks after surgery

Data from ClinicalTrials.gov

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