The Ability of Adipose Flap Over the NVB to Improve Sexual and Urinary Function Following Radical Prostatectomy; a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Erectile function
研究概览
简要总结
Despite technological advances, incontinence and impotence remain significant side effects of radical prostatectomy (RP). Strategies have been developed to reduce the injury to the erection nerves (i.e. neurovascular bundle - NVB)during surgery to further improve functional outcomes after RP. Adipose tissue is known for its stabilizing and even healing potential. These features include reducing the inflammatory process and improving blood supply to an injured nerve. We hypothesized that covering the NVB with periprostatic fat during surgery may potentially improve neural recovery and enhance functional recovery after RP. We sought to examine our hypothesis in a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged 18 years and older.
- •Patients diagnosed with prostate cancer.
- •Patients should be potent (IIEF erectile function domain score of 26 and above) and have a sexual partner.
- •Patients scheduled for Radical Prostatectomy with NVB preservation (at least unilateral).
排除标准
- •Patients who did not undergo NVB preservation or technical inability to create flap
研究组 & 干预措施
Adipose Flap
Covering neurovascular bundle with fat
干预措施: Technical modification during radical prostatectomy (Procedure)
Control
No adipose flap
结局指标
主要结局
Erectile function
时间窗: Change from Baseline IIEF score at 12 months
IIEF erectile function score
次要结局
- Continence status(Change from Baseline King's score at 12 months)