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临床试验/NCT04305379
NCT04305379终止不适用

Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
31
试验地点
2
主要终点
EPIC Urinary Incontinence subscale score

研究概览

简要总结

The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.

详细描述

A bladder neck reconstruction is a standard step in performing a radical prostatectomy. Over the years, various maneuvers to improve continence have been tried and studied including intussusception stitches and slings. Slings of various origins have been used by surgeons at the time of radical prostatectomy without consistent evidence demonstrating a benefit (vas deferens, biologic). However, use of the medial umbilical ligament to create a sling has not previously been studied in a randomized trial.

The medial umbilical ligaments are normally cut during intraperitoneal robotic-assisted laparoscopic radical prostatectomy to allow the surgeon access to the Retzius space between the bladder and pubic bone. To create a medial umbilical ligament autologous sling, the ligaments are dissected out and wrapped around the vesicourethral anastomosis.

The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.

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
Double (Participant, Outcomes Assessor)

盲法说明

The surgeon will be masked until the time of bladder neck reconstruction during the radical prostatectomy.

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men aged 40 to 70 years of age with localized prostate cancer (clinical stage T2c or less, Gleason grade 5+5=10 or less without any evidence of distant metastases)
  • Scheduled to undergo curative robot-assisted radical prostatectomy

排除标准

  • Planned pre-operative or post-operative (within 1 month) androgen therapy
  • Planned pre-operative or post-operative (within 1 month) radiation therapy
  • History of spinal trauma or surgery to the brain or spinal cord
  • Pre-operative history of stress urinary incontinence

结局指标

主要结局

EPIC Urinary Incontinence subscale score

时间窗: 1 Month

Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).

次要结局

  • EPIC Urinary Incontinence subscale score(12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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