Effect of early Foley catheter removal on hospital discharge timing following paediatric laparoscopic pyeloplasty: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AIIMS
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Duration of Hospital Stay (measured in days from the time of shifting child to post operative ward to hospital discharge) for both the groups
研究概览
简要总结
Pelvic-ureteric junction obstruction (PUJO) is one of the most common causes of congenital upper urinary tract obstruction. Antenatal hydronephrosis is seen in 1 in 7 neonates. The incidence of PUJO is one in 1000 to one in 2000 live births. Various options available for management of clinically significant PUJO are Open, Laparoscopic, and Robotic assisted Pyeloplasty. With development of minimal access surgery, the main focus is on to reduce hospital stay to reduce overall cost. Average hospital stay for laparoscopic and robotic assisted paediatric pyeloplasty is 3-5 days. In this study, foley’s catheter will be removed on post operative day 1 in group 1 patient to facilitate earlier discharge from the hospital and to see clinically significant differences as a primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children (less than or equal to 14 years) who are diagnosed with pelviureteric junction obstruction (PUJO) and planned for pediatric laparoscopic pyeloplasty at AIIMS, New Delhi.
排除标准
- •Children who are previously operated (renal or ureteral surgery) or having a recurrent PUJO.
- •Children who are having ectopic kidney, horse shoe kidney, and duplex collecting system.
- •Children who are associated with Vesicoureteric reflux and Lower urinary tract symptoms.
- •Children (including LAR) who are not consenting for the study
- •Children in whom DJ stent was not placed intra operatively.
结局指标
主要结局
Duration of Hospital Stay (measured in days from the time of shifting child to post operative ward to hospital discharge) for both the groups
时间窗: 1-5 days
次要结局
- Clavien-Madadi Grading for Postoperative Complications: The frequency & severity of complications will be categorized using the Clavien-Madadi classification (Yes/No) & further categorised into Grade I-II (minor complications) to Grade III-V (severe complications requiring invasive interventions). This will be assessed during hospital admission in post operative stay.
研究者
Dr Deepak Chandra Badhani
AIIMS NEW DELHI