NCT04198285终止不适用
Post-Operative Voiding After Gynecological Surgery (POVAGS) Trial: a Randomized Controlled Trial on Retrograde Bladder Filling After Outpatient Gynaecological Laparoscopy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Time to first void
研究概览
简要总结
To determine whether partially filling the bladder after outpatient gynaecological laparoscopy expedites time to first void and discharge. Methods: A single site, single-blinded, randomized control trial in which eligible patients undergo partial retrograde bladder filling immediately post-operatively compared to bladder drainage and foley catheter removal. Primary outcome is time to first void, secondary outcomes include time to discharge, post-operative complications and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, 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
- •Undergoing elective laparoscopy for a gynaecological indication
- •Plan for same day discharge
- •Able to provide informed consent
排除标准
- •Pregnancy
- •Undergoing procedure for pelvic organ prolapse, stress urinary incontinence, or nerve detrapment
- •Prior hysterectomy, or incontinence/pelvic organ prolapse procedures
- •Pre-existing voiding dysfunction
- •Known recurrent urinary tract infections
- •Known genito-urinary malformations
- •Known for neuromuscular disorders such as multiple sclerosis
- •Use of anticholinergic medication
- •Intraoperative bladder related complications
- •Need for discharge with indwelling foley catheter
- •Patients requiring overnight admission for any reason
结局指标
主要结局
Time to first void
时间窗: 3 hours
Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void
次要结局
- Time to discharge(8 hours)
- Post-operative complications(1 week following surgery)
- Patient satisfaction(1 week)
- Post-operative pain(Assessed at the 1 hour mark)
研究者
Jonathon Solnik
Site Chief of Gynecology
Women's College Hospital
研究点 (2)
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