A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RALP) - Effect on Potency Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Return to sexual function
研究概览
简要总结
The investigators will examine the beneficial impacts of applying of dHACM on the preserved neurovascular bundles (cavernosal nerves) and the prostate bed during robotic assisted laparoscopic prostatectomy. Such application can result in promotion of soft tissue healing and reduction of inflammation at the operative site and thus an acceleration of return of potency regulating cavernosal nerves.
详细描述
The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/chorion membrane (dHACM) in reducing neurovascular bundle inflammation in prostate cancer patients undergoing bilateral full nerve sparing robotic assisted laparoscopic radical prostatectomy (RALP). Specifically, this study compares potency outcomes in patients who had full nerve sparing RALP procedures with dHACM application to the neurovascular bundles to that of full nerve sparing RALP without dHACM application to neurovascular bundles.
Patients will be randomized to one of two possible treatment groups:
- Group 1 - Treatment Group ( Full Nerve Sparing RALP + AmnioFix®)
- Group 2 - Control Group ( Full Nerve Sparing RALP alone)
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
- Single (Participant)
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
- 否
入选标准
- •Male subjects between the ages 40-
- •Primary diagnosis of prostate cancer requiring surgical intervention
- •Have a willingness to comply with follow-up examination
- •Have ability to provide full written consent
- •Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, 7,8 or 9
- •Planned elective radical prostatectomy with bilateral full nerve sparing technique
- •Patients who currently have a pre-operative SHIM > 19
- •Negative urinalysis within 7 days prior to date of surgery
排除标准
- •Has signs or symptoms of any other disease which could result in allograft failure, or has experienced graft failure in the past
- •Has any condition(s), which seriously compromises the subject's ability to participate in this study, or has a known history of poor adherence with medical treatment
- •Has comorbid conditions that can be confused with or can exacerbate the condition, including diabetes or Advanced atherosclerotic vascular disease
- •Is unable to sign or understand informed consent
- •Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor
- •Has a history of drug or alcohol abuse within last 12 months
- •Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
- •Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)
- •Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
- •Patients currently enrolled in another study. Concurrent enrollment in another study is prohibited
- •Has had prior hormonal therapy such as Lupron or oral anti-androgens
- •Living outside of United States
- •Partial nerve sparing technique used during Radical Prostatectomy
结局指标
主要结局
Return to sexual function
时间窗: 12 months
Patient directed questionnaire
Potency as assessed by Sexual Health Inventory for Men (SHIM) Score
时间窗: 12 months
As measured by SHIM
次要结局
- Continence(12 months)