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临床试验/NCT03525756
NCT03525756已完成不适用

Cystogram for Early Foley Catheter Removal Post Colovesical Fistula Resection

Mount Carmel Health System1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Successful Foley Catheter Removal at Day 2

研究概览

简要总结

Colovesical fistulas are well-recognized but relatively uncommon pathology to both the general and colorectal surgeon. It is a complication arising from an underlying primary acute to chronic inflammatory process. Although colovesical fistulas are uncommon, they are associated with significant morbidity, affect quality of life, and may lead to death, usually secondary to urosepsis. Early diagnosis and management is essential.

The purpose of the study is to determine the objective use of cystographic evaluation on postoperative day two to guide early Foley catheter removal post colovesical fistula takedown. The hypothesis is that a cystogram showing no extravasation of contrast on postoperative day two will predict safe removal without increased morbidity.

This is an uncontrolled, single arm trial. Patients who meet criteria to undergo either minimally invasive or open colovesical fistula takedown with sigmoid colectomy, without evidence of the need for bladder repair will be eligible to participate. An indwelling Foley catheter is placed intraoperative and continued postoperative. All patients who consent to participate would undergo a cystogram on postoperative day two. The cystogram will be conducted by a radiologist and technician well-trained in the techniques and interpretation of the study. The colorectal surgery enhanced recovery protocol will be followed on all patients with the exception of the cystogram being conducted on post-op day two. If there is no evidence of extravasation of dye is seen on the cystogram the Foley catheter will be removed. Patients will be monitored closely following catheter removal to ensure self-diuresis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients with clinical, radiographic, or endoscopic confirmation of a colovesical fistula
  • patients undergoing either minimally invasive or open colovesical fistula takedown with sigmoid colectomy, without evidence of the need for bladder repair

排除标准

  • malignant disease
  • Crohn's disease
  • radiation-induced colovesical fistula
  • current pregnancy

结局指标

主要结局

Successful Foley Catheter Removal at Day 2

时间窗: 16 Hours After Foley Catheter Removal

Defined as no evidence of extravasation of dye is seen on the cystogram on day two, followed by successful self diuresis within 16 hours of Foley catheter removal.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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