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临床试验/NCT03959917
NCT03959917Unknown不适用

Bipolar Transurethral Resection of the Prostate; Complications and Possibility to do as Outpatient Procedure

Umeå University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Proportion of patients readmitted to hospital the first day of surgery

研究概览

简要总结

This study aims to investigate the impact of transurethral prostate resection in regard to complications. These are direct surgical complications, such as bleeding, infection and readmissions, as well as the long term complications as incontinence and impotence. Also, the study aims to investigate if selected cases of patients could be performed as outpatient surgery, thereby reducing cost.

详细描述

Transuretral prostate resection (TUR P) is a common procedure to relieve voiding problems in men. After the introduction of bipolar resection with saline, the serious complication of transurethral resection syndrome (i.e. acute hypo-natremia) has been eradicated.

The post surgical care is generally a couple of days inhospital care. The reson for this, is the risk of clot formation and in rare cases post surgical infection.

However, in selected cases, outpatient surgery has been performed with encouraging results. However, the technique has not been spread widely. The use of ambulatory surgery would reduce the direct cost of the procedure, thereby increasing it´s availability.

Also, complications in contemporary TUR P in the modern era (outside of the selected patients of clinical trials) is lacking. The information of complications that can be expected is therefore an important for patient counseling. In some studies, the use of incontinence pads after TUR P is more than 15%, which is important to reliably ascertain if this is holds true.

研究设计

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

入排标准

性别
Male
接受健康志愿者

入选标准

  • Planned for transurethral resection of the prostate (TUR P)

排除标准

  • No consent to participate

结局指标

主要结局

Proportion of patients readmitted to hospital the first day of surgery

时间窗: One day

Proportion of patients able to be discharged the day of surgery

时间窗: One day

次要结局

  • Readmission rates within 30 days of surgery(30 days)
  • Proportion catheter free(6 months)
  • Change in IPSS score(6 months)
  • Number of patients with cancer in surgical specimen(6 months)
  • Complications(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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