NCT02742636已完成不适用
When is the Best Moment to Remove the Urinary Catheter After Laparoscopic Hysterectomy: MUCH Study.
Leiden University Medical Center10 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2016年5月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 10
- 主要终点
- Urinary retention (inability to void)
研究概览
简要总结
Objective: The aim of this study is to evaluate if direct removal of the urine catheter after an laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery, which is the current treatment. In addition, we want to investigate patient's experience on this subject.
Study design: Randomized Controlled trial, non-inferiority study.
Study population: Women older than 18 years old, who are a laparoscopic hysterectomy for benign indication or low-grade malignancy.
Intervention:
- Group A (treatment group): the patients in this group will have their catheter directly removed in the OR after LH.
- Group B (control group): the patients in the control group will have their catheter removed according to the regular protocol of the hospital (at least 6 hours in place).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years
- •Scheduled for LH for benign indication or low-grade malignancy (with or without salpingo-oophorectomy)
排除标准
- •Concomitant procedures such as prolapse surgery, severe endometrioses and/or bowel resection
- •Preoperative known urinary voiding problems (incontinence)
- •Preoperative known urinary tract infection
- •Patients suffering from diseases potentially associated with inability to void (e.g. MS)
- •A Gravid or postpartum hysterectomy
结局指标
主要结局
Urinary retention (inability to void)
时间窗: 6 hours after removal of urinary catheter
次要结局
- Patient satisfaction (self-administrated questionnaire)(6 hours postoperative; 24 hours and 6 weeks)
- Rate of re-catheterisation(6 hours without voiding)
- Urinary tract infection (by performing a urine dipstick test and based on clinical symptoms)(Dipstick: first urine after removal of catheter (group 1: direct after OR, group 2: at least 6 hours after OR), clinical symptoms through study period (up to 6 weeks postoperative))
- Visual analogue scale score (VAS score)(6 hours postoperative; 24 hours)
研究者
FWJansen
Prof. Dr
Leiden University Medical Center
研究点 (10)
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