Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy: A Factorial 2-by-2 Open-labeled Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Febrile morbidity
研究概览
简要总结
Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile morbidity after total abdominal hysterectomy
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who undergoing total abdominal hysterectomy
- •Woman who agrees to participate in this study
排除标准
- •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
结局指标
主要结局
Febrile morbidity
时间窗: 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
次要结局
- Vaginal cuff infection(2 weeks after surgery)
- Other infectious morbidities(2 weeks after surgery)