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临床试验/NCT03480074
NCT03480074已完成不适用

Endoscopic Stapling Versus Suture Ligation of Dorsal Venous Complex During Robot-Assisted Laparoscopic Prostatectomy: A Randomized Prospective Study

Swedish Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Post-operative Continence Rates

研究概览

简要总结

The purpose of the study is to compare the results of three standard of care surgical methods [stapling versus selective suture ligation (cut, then sew) versus single suture ligation (sew, then cut) of the dorsal venous complex (DVC)] during robotic prostate surgery to see which is better for the patient's recovery.

详细描述

The dorsal venous complex (DVC) lies on top of the prostate gland, and carries blood away from the penis. It has to be tied off, or ligated, to remove the prostate gland. The DVC lies very close to nerves that help men get and maintain erections. In addition, the DVC is close to muscles that control passing urine. How the DVC is handled during prostate surgery may result in cancer being left behind to grow and spread in the body. The purpose of this study is to compare the results of stapling versus selective suture ligation (cut, then sew) versus single suture ligation (sew, then cut) of the DVC during robotic prostate surgery to see which is better for the patient's recovery.

This research is being done because doctors do not know which of these three commonly-used methods is better to reduce blood loss and reduce the chance of cancer left behind during surgery, and regain urine control and improve erectile function after surgery. Doctors also do not know if these methods affect the prostate-specific antigen (PSA) level in the blood after surgery.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Males over 18 years of age
  • •Must be scheduled to undergo standard of care robot-assisted laparoscopic prostatectomy (RALP)
  • •Must sign informed consent to be randomized between the three surgical arms

排除标准

  • •Patient is unwilling or unable to provide informed consent

研究组 & 干预措施

Single Suture Ligation

Active Comparator

Arm 3: Single Suture Ligation

干预措施: Single Suture Ligation (Procedure)

Selective Suture Ligation

Active Comparator

Arm 2: Selective Suture Ligation

干预措施: Selective Suture Ligation (Procedure)

Staple Ligation

Active Comparator

Arm 1: Staple Ligation

干预措施: Staple Ligation (Procedure)

结局指标

主要结局

Post-operative Continence Rates

时间窗: 2 years

The amount of time after surgery for a patient to regain continence (is no longer using pads).

次要结局

  • Post-operative Erectile Function(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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