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临床试验/NCT06977906
NCT06977906招募中不适用

Improved Robotic-Assisted Radical Prostatectomy for Locally Advanced Prostate Cancer: Bladder Suspension and Preliminary Outcomes

First Affiliated Hospital of Fujian Medical University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年1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
招募中
入组人数
300
试验地点
1
主要终点
The degree of bladder descent

研究概览

简要总结

This study is a prospective, single-center clinical trial. It aims to establish an improved robotic-assisted radical prostatectomy for treating locally advanced prostate cancer. The technique evaluates the impact of preserving the anterior peritoneum of the bladder on postoperative bladder descent and urinary control recovery. A retrospective analysis compares this modified approach with traditional anterior approach surgery, assessing differences in oncological outcomes, early functional recovery, and postoperative complication rates. The goal is to provide new theoretical foundations and technical support for the prevention and treatment of postoperative urinary incontinence.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Male
接受健康志愿者
否

入选标准

  • •prostate biopsy and clinical confirmation of high-risk prostate cancer (PSA > 20 ng/mL, Gleason score ≥ 8, or cT stage ≥ T2c) followed by robotic-assisted radical prostatectomy
  • •multiparametric MRI (mpMRI) with a 3.0 T scanner for prostate or pelvic scans performed within 30 days before the operation at our center
  • •Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 1
  • •Complete clinical and prostate biopsy pathological data.
  • •General health is good, with no infections, autoimmune diseases, hematologic disorders, or other malignancies.

排除标准

  • •Presence of surgical contraindications.
  • •refusal of enhanced mpMRI imaging.

研究组 & 干预措施

conventional Robotic Assisted Radical Prostatectomy group

Active Comparator

The conventional RARP utilizes a traditional anterior approach through the patient's head-down, feet-up supine position, with either transabdominal or extraperitoneal access. After establishing pneumoperitoneum, precise dissection of the Retzius space is performed to expose the prostate and surrounding structures. The deep dorsal venous complex is pre-emptively ligated to control bleeding, followed by sharp dissection of the bladder neck while preserving the ureteral orifices. The seminal vesicles and vas deferens are then mobilized, with selective preservation of the neurovascular bundles based on the tumor's characteristics to maintain erectile function. The prostate apex and urethra are delicately dissected while protecting the sphincter, and after complete prostate removal, a continuous, tension-free anastomosis of the bladder and urethra is performed using absorbable sutures. Lymph node dissection is carried out if necessary. Throughout the procedure

干预措施: Improved Robotic-assisted radical prostatectomy group (Procedure)

Improved Robotic-Assisted Radical Prostatectomy group

Experimental

The procedure is performed in a head-down, feet-up supine position with an abdominal or extraperitoneal approach. The right peritoneum is opened along the right external iliac vein to clear the obturator nerve, vessels, and lymph nodes. The external and internal iliac lymph nodes are also cleared. The right pelvic fascia is incised to remove prostate fat while preserving the bladder's anterior wall peritoneum. The same approach is used on the left side. The peritoneum is retracted to clear anterior prostate fat, and the deep venous complex is ligated to expose the prostate. Prostatectomy is performed, followed by urethra and bladder anastomosis, and peritoneal suturing with drainage tube placement.

干预措施: conventional Robotic-assisted radical prostatectomy group (Procedure)

结局指标

主要结局

The degree of bladder descent

时间窗: 1 month after operation

Time Frame:1 month after operation

rate of continence

时间窗: 1 week, 1 month and 3 month after postoperative removal of the urinary catheter

Time Frame:1 week, 1 month and 3 month after postoperative removal of the urinary catheter

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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