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临床试验/NCT05020613
NCT05020613Unknown不适用

Comparison of Early and Late Removal of the Urinary Catheter After Low Anterior Resection

Marmara University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Post-operative urinary retention requiring re-catheterisation

研究概览

简要总结

It was aimed to investigate the need for urinary retention and recatheterization in the postoperative period by removing the urinary catheter in patients undergoing low anterior resection, in the early or late period.

详细描述

Urinary catheter is placed before abdominal surgery to increase visualization during the operation, prevent bladder injury and provide perioperative urine output monitoring. It is especially useful in patients who will undergo low anterior resection, with a high risk of nerve damage and consequent urinary retention and bladder dysfunction. Urinary catheter removal time differs between operations. Traditionally, the urinary catheter is kept in place for 7 days because urinary retention occurs in some patients whose urinary catheter is displaced in the early period. As the urinary catheter retention time increases, the risk of urinary tract infection also increases.

According to the current ERAS protocol, it is recommended to remove the urinary catheter 48 hours after the surgery in patients who have undergone colorectal surgery and are treated with epidural pain management. However, the ERAS protocol is not specific to patients who have undergone low anterior resection, which is the main point of our study and includes all patients who have undergone colorectal surgery. Most authors still believe that prolonged retention of the urinary catheter will prevent urinary retention and long-term bladder dysfunction. In a randomized controlled study (published in 1999) that we encountered during our own literature search, early removal of the urinary catheter was associated with increased urinary retention [2]. In recent studies, some authors have associated the early removal of the urinary catheter with increased urinary retention [3], while others claimed the opposite and reported contradictory results [4]. Advances in laparoscopic techniques have made it possible to visualize the hypogastric and pelvic nerves (nerves associated with urinary functions) during surgery. In addition to these developments, dissections on embryonic planes and tumor reduction with neoadjuvant chemotherapy protect these nerves during surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Patients who will undergo Low Anterior Resection due to rectal cancer in the Department of General Surgery of our university.
  • Competent to consent to participate in trial
  • Elective surgery
  • ASA classification of 1~3

排除标准

  • Patients whose post-treatment status cannot be obtained.
  • Having Bladder surgery before
  • Having a previous prostate surgery.
  • Patient's refusal to participate in the study.

结局指标

主要结局

Post-operative urinary retention requiring re-catheterisation

时间窗: 1 day

Development of acute post-operative urinary retention requiring re-catheterisation within 1 day of removal of urethral catheter in the post-operative period.

Postoperative urine culture

时间窗: 7 days

Investigate any colonization before discharge in both groups

Discharge with urinary catheter

时间窗: 7 days

Any need for urinary catheter at the time of the discharge

次要结局

未报告次要终点

研究者

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

Tevfik Kivilcim Uprak

MD

Marmara University

研究点 (2)

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