Phase I Clinical Trial: Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Adverse events measured by the Clavian-Dindo classification
研究概览
简要总结
The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, NR-RALP, which incorporates a genitofemoral (GFN) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure
详细描述
Patients will have baseline evaluation with International Index of Erectile Function-5 (IIEF-5) questionnaire and the Short Form McGill Pain Questionnaire (SF-MPQ)1, which will be re-evaluation at time of their standard of care post-operative visits at 4 weeks, 3-, 6-, 12- and 18-months. Post-operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of:
- •Gleason grade ≥8
- •>pT2 on preoperative MRI imaging
- •Patients must have preoperative erectile function with a baseline IIEF score of ≥17
排除标准
- •Patients with previous pelvic surgery
- •Patients with previous pelvic radiotherapy
- •Patient with previous focal therapy for prostate cancer
- •Patients aged < 18 years at diagnosis
- •Legally incapable patients
- •Patients who are unable to complete questionnaires and have no companion to help complete them
- •Patients undergoing a concomitant cancer surgery
- •Patients with pre-existing neurologic disease
结局指标
主要结局
Adverse events measured by the Clavian-Dindo classification
时间窗: Through study completion, an average of 18 months
The primary outcome is specifically the safety of the operation measured by adverse events as defined by the Clavian-Dindo classification. The measurement varies from Grade I (Best possible outcome) to Grade V (Worst possible outcome). Grade I Deviation from normal p/o course. No pharmacological or surgical treatment, endoscopic or radiological interventions were required. Acceptable therapeutic drugs such as anti-emetics, antipyretics, analgesics, diuretics,electrolytes, physiotherapy. Wound infections, small abscess requiring incision at bedside. Grade II Normal course altered. Pharmacological management other than in Grade I. Blood transfusions and total parenteral nutrition are also included. Grade III Complications that require intervention of various degrees. Grade IV Complications threatening life of patients (including Central Nervous System complications), requiring Intensive Treatment Unit support. Grade V Death of a patient.
次要结局
- International Index of Erectile Function-5 (IIEF-5)(18 months post-NR-RALP procedure)
- Short Form McGill Pain Questionnaire (SF-MPQ)(18 months post-NR-RALP procedure)
研究者
Victor McPherson
MD, MSc, FRCSC, Assistant Professor Division of Urology
Sir Mortimer B. Davis - Jewish General Hospital