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临床试验/NCT06737393
NCT06737393招募中不适用

Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: a Randomized Controlled Trial

University of Tennessee2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
112
试验地点
2
主要终点
Time to discharge

研究概览

简要总结

The investigators hypothesize that backfilling the bladder postoperatively will reduce time to spontaneous void and subsequent discharge from the post-anesthesia care unit.

详细描述

This is a prospective, single-blinded, randomized clinical trials in which patients undergoing laparoscopic hysterectomy will be randomized in a 1:1 ratio to have the bladder backfilled at the completion of the surgery prior to Foley catheter removal. If the patient is assigned to group A, 200 mL of room temperature, sterile normal saline will be instilled retrograde into the bladder at the completion of the surgery prior to Foley catheter removal and the Foley subsequently removed intraoperatively. If the patient is assigned to group B, the Foley catheter will be removed intraoperatively at completion of the procedure. The standard protocol is to use a 16F Foley catheter for gynecologic laparoscopy cases, and patients in both groups will receive the same size catheter. After surgery, time to discharge and time to void will be recorded.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 to 80
  • Undergoing planned laparoscopic hysterectomy as a day surgery procedure

排除标准

  • Women younger than 18 or older than 80 years of age
  • Undergoing a non-laparoscopic unplanned surgical procedure

结局指标

主要结局

Time to discharge

时间窗: Within 3 days following surgery

The time to discharge for each participant, which will be defined as the length of time from surgery completion to discharge from the post-anesthesia care unit, will be recorded.

次要结局

  • Time to void(Within 3 days following surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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