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临床试验/NCT07417475
NCT07417475已完成不适用

Early Functional Outcomes After Robot-Assisted Radical Prostatectomy: A Prospective Comparison of the HOOD Technique Versus Standard Anterior Reconstruction

Araz Musaev1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Functional outcomes

研究概览

简要总结

This prospective, non-randomized cohort study included consecutive patients undergoing robotic-assisted laparoscopic radical prostatectomy (RARP) between January 2024 and January 2026 following ethics committee approval. Patients with clinically localized prostate cancer eligible for bilateral nerve-sparing surgery were enrolled. Two surgical techniques-anterior-posterior reconstruction (APR) and the HOOD technique-were compared. All procedures were performed by a single high-volume surgeon at a tertiary referral center. The primary endpoint was early urinary continence recovery, assessed at catheter removal and at 3, 6, and 12 weeks postoperatively. Secondary outcomes included postoperative complications, positive surgical margin rates, and early oncological outcomes.

研究设计

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

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • life expectancy >10 years,
  • clinically organ confined disease (cT1-cT2),
  • biopsy ISUP GG ≤3,
  • total serum prostate-specific antigen (PSA) ≤10 ng/ml
  • normal preoperative continence and potency

排除标准

  • high risk prosatate cancer
  • M1 prostate cancer (according to preoperative GA68 PSMA PET CT)
  • pre-existing urinary incontinence,
  • previous prostatic, urethral, bladder neck surgery
  • neoadjuvant therapy
  • prior pelvic radiotherapy

研究组 & 干预措施

HOOD technique

Experimental

干预措施: Prostatectomy with HOOD techinque (Procedure)

Anterior-Posterior reconstruction

Active Comparator

干预措施: Prostatectomy with anterior-posterior renconstruciton (Procedure)

结局指标

主要结局

Functional outcomes

时间窗: 3 weeks , 6 weeks and 12 weeks after surgery.

The Urinary continance recovery rates at the catheter removal, and subsequently at 3 weeks , 6 weeks and 12 weeks after surgery.

次要结局

未报告次要终点

研究者

发起方
Araz Musaev
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Araz Musaev

Dr

Ankara University

研究点 (1)

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