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Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum

2017年2月23日 更新者：Peking Union Medical College Hospital

Amonocenter, Prospective, Randomized Clinical Trial to Investigate the Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum.

Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but there is no clear data on the incidence of urine retention.Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum

研究概览

地位

未知

条件

干预/治疗

详细说明

For a better view to avoid accidental trauma and monitoring kidney function during surgery and in the post-surgery period, patients undergoing abdominal operations will usually have a urinary catheter placed in the bladder before the surgery. Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief.

Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum

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研究类型

介入性

注册 (预期的)

220

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Beijing
      • Beijing、Beijing、中国、100730
        • Peking Union Medical College Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Competent to consent to participate in trial
  2. Patients with rectal cancer who underwent total or tumor-specific-mesorectal excision with colorectal or colonanal anastomosis
  3. Elective surgery
  4. ASA classification of 1~3
  5. If male, international prostate symptom score <20.

Exclusion Criteria:

  1. Combined pelvic surgery(pelvic lymph node dissection, hysterectomy, salpingo-oophorectomy, posterior vaginectomy, cystectomy, ureteral double-J stenting, ureterectomy, ureteroureterostomy, prostatectomy)
  2. Postoperative complications with a Dindo grade III or more
  3. Known urinary disease(end-stage renal disease, benign prostatic hyperplasia, neurogenic bladder, malignancy)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Early removal group
All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the experimental arm will have their urethral catheters removed at 2 days following surgery.
程序：Early removal group
Participants assigned to the experimental arm will have their urethral catheters removed at 2 days after after laparoscopic anterior resection of the rectum.
有源比较器：Normal removal group
All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.
程序：Normal removal group
Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Post-operative urinary retention requiring re-catheterisation
大体时间：1 day following urethral catheter removal
Development of acute post-operative urinary retention demonstrated by a post-void residual >100mls on bladder ultrasound requiring re-catheterisation within 1 day of removal of urethral catheter in the post-operative period
1 day following urethral catheter removal

次要结果测量

结果测量
措施说明
大体时间
Urinary tract infection
大体时间：Within 7 days of urethral catheter removal
Before catheter removal, take a mid-stream urine sample for microscopy and culture. Leucocyte in urine ≥5/HP for man and ≥10/HP for woman is defined as bacteruria with urinary irritation or not.A pure culture of a single organism of >100,000 colony forming units will be considered a positive culture.
Within 7 days of urethral catheter removal
Urethrorrhagia
大体时间：Within 7 days of urethral catheter removal
take a mid-stream urine sample for Clinical urine tests and RBC≥3/HP is defined as urethrorrhagia.
Within 7 days of urethral catheter removal

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peking Union Medical College Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2017年2月1日

初级完成 (预期的)

2017年7月1日

研究完成 (预期的)

2017年8月1日

研究注册日期

首次提交

2017年2月23日

首先提交符合 QC 标准的

2017年2月23日

首次发布 (实际的)

2017年2月28日

研究记录更新

最后更新发布 (实际的)

2017年2月28日

上次提交的符合 QC 标准的更新

2017年2月23日

最后验证

2017年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ARCTIC

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Other researchers have access to data in the form of published papers

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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