A randomised controlled trial of early versus routine removal of self retaining urinary catheter after uncomplicated total laproscopic hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Voiding difficulty after ECR (time frame : 6 hours after removal of catheter) in uncomplicated TLH patients
研究概览
简要总结
DuringTotal laparoscopic hysterectomy (TLH), standard care is to place an indwelling catheter,usually self-retaining, during surgery to avoid iatrogenic injuries of the bladder, monitor urinary output and check for hematuria.
Timeof removal of this catheter in uncomplicated cases is usually after 24 hours.There is limited guidelines for catheter removal post-TLH.
Accordingto Cochrane review (2008), catheter placement should only be as long asrequired, as prolonged catheterization is associated with urinary tractinfections, delayed mobilization of patients and longer time to dischargeincreasing unnecessary hospital stay. Patients too have discomfort while oncatheter.
IfECR outcomes are found to be similar or better than RCR, patients maybedischarged earlier reducing hospital stay and well-being.
ProblemStatement/ Rationale: early removal of the cathetermay overcome all these issues but also have been associated with higher urinaryretention rates and re-catheterization. However, many centers have now starteddaycare hysterectomy requiring immediate or early removal of catheter butevidence for this is limited.
Novelty: Withthis in mind, we intend to evaluate if early catheter removal (ECR- <4 hours)after TLH was associated with similar or better outcomes compared with routinecatheter removal (RCR- >24hrs) through this study,it proves its Originality.
Research Question: To see voiding difficulty after early vs delayedremoval of urinary catheters.
Research Hypothesis: The study is based on the assumption that ECR has similar/better outcomes than RCR
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •All patients posted for TLH for the benign indication (e.g. AUB, Fibroids) and low-grade malignancy.
- •Patients willing to participate in the study.
排除标准
- •Patients not willing to participate in the study 2) Pregnant women 3) TLH patients having concomitant procedures such as prolapse surgery 3) TLH patients with extensive adhesions like endometriosis surgery or advanced oncological dissection including nodal dissection 4) Those with stress and urge incontinence 5) Patients with pre-op UTI 6) Inability to void (paraplegia, MS).
结局指标
主要结局
Voiding difficulty after ECR (time frame : 6 hours after removal of catheter) in uncomplicated TLH patients
时间窗: 6 hours after removal of catheter
次要结局
- a.PVR ( post void residual urine)(b.Rate of recatheterisation)