Prospective Single-Center Randomized Study of Robotic Athermal Nerve-Sparing Radical Prostatectomy: Laparoendoscopic Single-Site Versus Standard Approach
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Mean pain score, evaluated with the visual analog pain score (VAPS)
研究概览
简要总结
This randomized clinical trial compares a recently developed technique, called robotic laparoendoscopic single-site radical prostatectomy (R-LESS RP), to the current standard of robotic technique for prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) in treating patients with newly diagnosed, locally confined prostate cancer. Both procedures are types of robotic radical prostatectomy, or the robot-assisted removal of the prostate though a small incision in the belly. In the standard approach, 4-5 small (1-2 cm) incisions are made in the lower abdomen to allow the insertion of robotic instruments. In the R-LESS technique, all instruments are inserted through a single incision. R-LESS RP is less invasive than RALP and may leave a smaller scar and cause less pain.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate pain and analgesic requirement of R-LESS RP compared to standard RALP.
SECONDARY OBJECTIVES:
I. Time to oral intake. II. Time to resume ambulation. III. Hospital stay, counted in whole days from the day of surgery to the day of discharge.
IV. Perioperative parameters, including: operative time (defined as time elapsed from skin incision to placement of the final skin suture); estimated blood loss; additional ports; conversion to standard RALP (in R-LESS RP patients), or laparoscopic, or open surgery; length of stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 72 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must have a biopsy proven newly diagnosed locally confined, stage T1a, T2a or T2b prostate cancer
- •Judged by the study doctor to be a suitable candidate for a radical prostatectomy
- •Serum prostate specific antigen equal to or less than 10 ng/mL
- •Gleason score equal to or less than 7
- •Life expectancy greater than 10 years
- •Prostate size on trans-rectal ultrasound (TRUS) measurement less than 50 grams
- •Favorable operative risk defined as American Society of Anesthesiology Score (ASA score) =< 3
- •Ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent
排除标准
- •Patients with any prior pelvic surgery
- •Patients with prior history of pelvic fractures or hip replacement
- •Large pelvic or intra-abdominal masses
- •Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions)
- •Poor surgical risk (defined as American Society of Anesthesiology Score > 3)
- •Active infection
- •Uncorrected coagulopathy
- •Body mass index equal to or greater than 35
研究组 & 干预措施
Arm I (RALP)
Patients undergo standard RALP.
干预措施: quality-of-life assessment (Other)
Arm I (RALP)
Patients undergo standard RALP.
干预措施: questionnaire administration (Other)
Arm II (R-LESS RP)
Patients undergo R-LESS RP.
干预措施: robot-assisted laparoscopic surgery (Procedure)
Arm II (R-LESS RP)
Patients undergo R-LESS RP.
干预措施: laboratory biomarker analysis (Other)
Arm II (R-LESS RP)
Patients undergo R-LESS RP.
干预措施: quality-of-life assessment (Other)
Arm II (R-LESS RP)
Patients undergo R-LESS RP.
干预措施: questionnaire administration (Other)
Arm I (RALP)
Patients undergo standard RALP.
干预措施: laboratory biomarker analysis (Other)
Arm I (RALP)
Patients undergo standard RALP.
干预措施: robot-assisted laparoscopic surgery (Procedure)
结局指标
主要结局
Mean pain score, evaluated with the visual analog pain score (VAPS)
时间窗: Up to 1 year
Compared using the Mann-Whitney U test as appropriate.
Mean analgesic consumption, obtained from medical charts and reported as units of parenteral morphine equivalents (mg)
时间窗: Up to 1 month
Compared using the Mann-Whitney U test as appropriate.
次要结局
- Time to oral intake(Up to 1 year)
- Time to resume ambulation(Up to 1 year)
- Length of hospital stay, counted in whole days from the day of surgery to the day of discharge(Up to 3 days)
- Operative time, defined as time elapsed from skin incision to placement of the final skin suture(Day 1)
- Estimated blood loss during surgery(Day 1)
- Additional ports during surgery(Day 1)
- Incidence of conversion to standard RALP, laparoscopic, or open surgery in R-LESS RP patients(Day 1)
- Incidence of intraoperative complications(Day 1)
- Incidence of postoperative complications, recorded according to the Clavien classification(Up to 1 year)
- Body image perception, measured using the BIQ(Up to 1 year)
- Scar evaluation, assessed using the Patient and Observer Scar Assessment Scale(Up to 1 year)
- Health related quality of life, measured as patients' perception of functioning, disability, and well-being(Up to 1 year)
- Urinary continence, assessed by the number of pads used daily(Up to 12 months)
- Erectile function, assessed by the IIEF-5(Up to 12 months)