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临床试验/NCT03126162
NCT03126162已完成不适用

A Randomized, Controlled Trial Evaluating 2 Techniques of Postoperative Bladder Testing for Patients Undergoing Same-day Total Laparoscopic Hysterectomy

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2017年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
1
主要终点
Time to first spontaneous void

研究概览

简要总结

The objective of this study is to determine if backfilling the bladder immediately post-operatively, prior to removal of the foley catheter, in patients undergoing same-day total laparoscopic hysterectomy will hasten time to first spontaneous void and time to discharge

详细描述

In recent years, a paradigm shift from traditional perioperative care models to "Enhanced Recovery After Surgery (ERAS)" has taken place across a wide range of surgical subspecialties including minimally-invasive gynecologic surgery. Many gynecologic procedures that once required hospital admission are now being performed as outpatient procedures. To optimize same-day discharge through the ERAS pathways, protocols call for early removal of urinary catheters following gynecologic surgery. Studies in urogynecologic literature have shown that a backfill-assisted voiding trial is superior to a spontaneous voiding trial in patients undergoing transvaginal surgery. However, there are limited studies published in literature focusing on minimally invasive gynecologic procedures, specifically laparoscopic hysterectomies. A successful spontaneous voiding trial is usually a postoperative criteria prior to discharge after same-day total laparoscopic hysterectomy. Through this randomized controlled trial, the investigators aim to compare two techniques of postoperative bladder testing for patients undergoing same-day total laparoscopic hysterectomy. This study would provide valuable data on improved measures for predicting voiding efficiency, time to first void, and time to discharge for patients undergoing same-day total laparoscopic hysterectomies. Ultimately, the investigators predict that backfilling the bladder immediately postoperatively, prior to removal of the foley catheter, will hasten time to first spontaneous void and reduce the amount of time spent in the recovery room.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will be randomly assigned to one of two groups - A) bladder backfilled group or B) control group. This is a blinded study and the participant will not know which group they were assigned to.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women aged 18-75 years of age
  • •Ability to comprehend English
  • •Women undergoing same-day laparoscopic hysterectomy through the Enhanced Recovery after Surgery (ERAS) protocol at Magee-Womens Hospital (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy)

排除标准

  • •Women who are unable to give informed consent
  • •History of prior or concurrent urogynecologic procedures performed including mid-urethral sling, rectocele/cystocele repairs, burch urethropexy, sacrospinous ligament fixation, uterosacral vaginal vault suspension, sacrocolpopexy
  • •History of multiple sclerosis
  • •Known malignancy of the bladder
  • •Bladder or ureteral injury that occurred intra-operatively
  • •Women who are being treated for an active urinary tract infection at the time of surgery
  • •Women admitted overnight who fail to go home the same day after total laparoscopic hysterectomy

研究组 & 干预措施

Bladder Backfilled group

Experimental

Subjects randomized to the bladder backfilled group (Group A) will have 200 mL of normal saline instilled into their bladders prior to removal of the foley catheter. The foley catheter will subsequently be removed

干预措施: InstilIing normal saline into bladder (Procedure)

Bladder Backfilled group

Experimental

Subjects randomized to the bladder backfilled group (Group A) will have 200 mL of normal saline instilled into their bladders prior to removal of the foley catheter. The foley catheter will subsequently be removed

干预措施: Removal of foley catheter (Procedure)

Control group

Placebo Comparator

Subjects randomized to the control group (Group B) will just have their foley catheters removed at the end of the surgery. This is routinely done post-operatively after routine gynecologic surgery.

干预措施: Removal of foley catheter (Procedure)

结局指标

主要结局

Time to first spontaneous void

时间窗: From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks

Our primary hypothesis is that patients who undergo same-day total laparoscopic hysterectomy that are randomized into the group who have their bladders backfilled with 200 cc normal saline post-operatively, prior to removal of the foley catheter will have a shorter time to first spontaneous void.

次要结局

  • Time to discharge from the hospital after same-day laparoscopic hysterectomy(From the date of randomization until the date of discharge from the hospital, assessed up to 4 weeks)

研究者

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

Suketu Mansuria

Associate Professor

University of Pittsburgh

研究点 (1)

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