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临床试验/NCT02277288
NCT02277288招募中不适用

Does Intraoperative Bladder Instillation Decrease Outpatient Recovery Time After Mid-Urethral Sling

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
2
主要终点
Time between surgery and discharge home

研究概览

简要总结

The purpose of this randomized control trial study is to determine if intraoperative bladder instillation of fluid decreases the time to discharge after having an outpatient mid-urethral sling procedure, and to measure the cost savings of this decrease in hospital stay. Charges will be broken down between recovery room charges and discharge area, as recovery room charges are significantly higher. The investigators suspect that a shorter time in the recovery room will translate into fewer charges.

详细描述

Urinary stress incontinence affects 4-35% of women. Due to the large economic impact and prevalence of the disease, urinary incontinence is a significant public health issue. With rising healthcare costs it has become increasingly important to manage patient care in the most cost-efficient manner. Considering the increasing number of women undergoing mid-urethral sling procedures, it is imperative that perioperative care is streamlined in order to minimize cost. The Cedars-Sinai Center for Continence and Women's Pelvic Health instituted a new practice pattern that enables patients to complete a voiding trial sooner after surgery compared to previous practice patterns thus allowing patients to be discharged earlier and ultimately decreasing cost. The purpose of this study is to compare the previous voiding trial practice (emptying the bladder at the end of surgery) versus the newly instituted practice (filling with bladder with 250cc) and perform a cost benefit analysis to determine if there is a significant decrease in recovery and discharge time. Both of these practices fall under the standard-of-care. However, of the several standard-of-care procedures, none have been tested for superiority. To date there are no randomized control trials that address this issue in female mid-urethral sling surgery.

Boccola et al showed in a study of 60 men who had undergone transurethral resection of the prostate (TURP) that by instilling the bladder with 300-500cc of warm saline the time to void was significantly decreased compared to standard indwelling catheter removal. It was also shown that the bladder instillation group had a significantly shorter time to discharge. The study suggested that given the significant decrease in time in recovery, this would be an ideal practice for many other outpatient procedures. Willson, et al, in another randomized trial of 75 men who underwent TURP, found that bladder infusion allowed early decision-making for discharge on the second postoperative day. Finally, McAchran and Goldman found that when patients were managed using a fast-track regimen in the outpatient setting after mid-urethral sling procedures the median time from the recovery area to discharge was less than 3 hours.

For our study, if a significant decrease in the time to discharge with the newly instituted practice pattern is demonstrated, then this practice can be adopted by other institutions and become the new standard of care to help decrease both cost and patient time in the hospital.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 years or older
  • History of stress urinary incontinence
  • Scheduled for outpatient mid-urethral sling procedure, any approach

排除标准

  • Age less than 18 years
  • Inability to give informed consent
  • History of urinary retention

结局指标

主要结局

Time between surgery and discharge home

时间窗: 2 Days

Will analyze if the time to discharge is shorter in those patients who have had bladder instillation versus those with an indwelling catheter postoperatively.

次要结局

  • Hospital charges(1 Month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer T. Anger

Principal Investigator

Cedars-Sinai Medical Center

研究点 (2)

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