When to Remove the Indwelling Catheter After Minimally Invasive Sacrocolpopexy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- Hospital stay
研究概览
简要总结
Objectives
The objective of this study is to help identify the best practice regarding the use of indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a randomized controlled trial comparing the immediate removal of indwelling urethral catheter, after minimally invasive sacrocolpopexy, to the present standard catheter removal on post operative day one. Evidence based catheter management will be helpful to both providers and patients in post-operative decision making.
Specific Aims
Aim 1: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1.
Aim 2: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy confers no increased risk of re-catheterization.
Aim 3: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy decreases the occurrence of urinary tract infection.
Design
A randomized controlled trial comparing the standard overnight indwelling urethral catheterization with removal of catheter immediately post surgery after minimally invasive sacrocolpopexy, at Oregon Health & Science University.
Outcome measures
Primary outcome measures are hospital stay in hours after completion of surgery and need for re-catheterization. Hospital stay will be counted from the time the patient leaves the operating room to the time she leaves the hospital. To avoid confounding, investigators are only including the first / morning case of the day. For re-catheterization, investigators will evaluate if patient was able to void after completion of surgery. Investigators will compare the post voiding residuals, the need for re-catheterizations and the numbers of patients going home with an indwelling catheter between the two groups. Investigators will also compare the number of urinary tract infections, as documented by urine culture and subsequent treatment, between the two groups.
Study Subjects
Study subjects will be women undergoing minimally invasive sacrocolpopexy. Women will be invited to participate in the study during their preoperative visit. If they agree to participation, this will be noted in their chart. Randomization to group will occur immediately following surgery.
详细描述
Objectives
The objective of this study is to help identify the best practice regarding the use of indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a randomized controlled trial comparing the immediate removal of indwelling urethral catheter, after minimally invasive sacrocolpopexy, to the present standard catheter removal on post operative day one. Evidence based catheter management will be helpful to both providers and patients in post-operative decision making.
Specific Aims
Placement of indwelling catheter after minimally invasive pelvic organ prolapse (POP) surgery is routine practice. There is limited evidence to support the use of overnight indwelling catheters, and despite this, the use of catheters after urogynecologic surgery remains common practice. The objective of this study is to help identify the best practice regarding the use of indwelling catheter after minimally invasive urogynecologic surgery. Dunn et al found that immediate removal of catheter after completion of an uncomplicated abdominal or vaginal hysterectomy was not associated with re-catheterization, urinary tract infections or fever. They also found that patients in whom the catheter was removed immediately had less pain compared to the patients who had indwelling catheter for 24 hours. The applicability of this study to Urogynecology is limited by the fact that patients with incontinence and / or prolapse were not included in it. Use of catheters after surgery may be convenient for providers, but the benefit to the patient is uncertain. Investigators believe that evidence with regards to the optimal use of catheter use in urogynecologic surgery will be helpful to the providers.
Risk of urinary tract infection increases the longer an indwelling catheter stays in a patient. Urinary tract infections associated with catheters (CAUTI) are responsible for 40% of hospital acquired infections. CAUTI are associated with 387, 550 hospital acquired infections in a year, which could be prevented. Investigators believe that avoiding placement of catheter after minimally invasive urogynecologic surgery will result in shorter hospital stay and reduction in CAUTI, thereby improving the quality and cost of health care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing minimally invasive sacrocolpopexy
- •Sacrocolpopexy with or without concomitant procedures
- •Patients having the first start surgery of the day to standardize hospital time.
排除标准
- •Elevated post void residual (PVR)
- •Mobility problems
- •Neurological conditions
- •Intra-operative cystotomy or urinary tract injury
研究组 & 干预措施
Immediate catheter removal
The indwelling Foley catheter will be removed prior to exiting the operating room.
干预措施: Immediate catheter removal (Procedure)
Post op day 1 catheter removal
Patients assigned to this group will follow the standard of care at present, with removal of indwelling catheter on the morning of postoperative day 1.
干预措施: Post op day 1 catheter removal (Procedure)
结局指标
主要结局
Hospital stay
时间窗: 4 weeks
Primary outcome measure is hospital stay in hours after completion of surgery. Hospital stay will be counted from the time the patient leaves the operating room to the time she leaves the hospital.
次要结局
- Urinary tract infection(upto 4 weeks)
- Re-catheterization(Upto 4 weeks)
研究者
W. Thomas Gregory
Associate Professor
Oregon Health and Science University