Febrile Morbidity
Conditions
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.
Interventions
PROCEDUREVagina douching
Vaginal douches with 1000 ml of 1% povidone-iodine solution on the night before surgery and again on the morning of surgery
PROCEDUREVagina painting
Vaginal painting of vagina stump after hysterectomy with 10% povidone-iodine solution 30 ml
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Factorial 2-by-2 open labeled randomised controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Thailand
Outcome results
None listed