Post-Operative Voiding After Gynecological Surgery (POVAGS) Trial: a Randomized Controlled Trial on Retrograde Bladder Filling After Outpatient Gynaecological Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 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
研究组 & 干预措施
Retrograde filled
This arm will contain patients who had retrograde bladder filling upon completion of surgery with 200 milliliters (mL) of sterile saline.
干预措施: Retrograde bladder filling (Procedure)
Control
This arm will contain patients who simply had the urinary catheter removed upon completion of surgery, and were left with an empty bladder.
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