Impact of Catheter Size on Peri-Operative Pain After Robotic Assisted Laparoscopic Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Catheter Related Pain: Visual Analog Score Rating
研究概览
简要总结
This study is designed to assess the effect of catheter size on postoperative catheter pain, urinary continence, urinary flow rates, post void residuals, International Prostate Symptom Scores (IPSS), and Quality of Life (QoL) score, as well as long term complications after robotic assisted laparoscopic prostatectomy.
详细描述
Subjects identified to receive a robotic assisted laparoscopic prostatectomy.were randomized to either a 16 French or 20 French catheter at the completion of the prostatectomy. All prostatectomies were performed by one of three surgeons at the investigator's institution. Preoperative demographics and operative data were recorded for each group. Catheters remained in place for 7-14 days. Subjects were asked on postoperative day 7 to report their catheter-related pain and amount of opioid medication used. Urinary symptoms and quality of life scores and pads per day were recorded at 6 weeks and 12 weeks post-operatively.
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
- 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
- •Identified as candidate for robotic assisted laparoscopic prostatectomy
排除标准
- •Having filled a prescription for opioid medication in last 2 months.
- •Known latex allergy
- •Known pre-operatively that catheter placement will exceed 14 days
- •History of pelvic radiation
- •Significant deviation from normal operative protocol
结局指标
主要结局
Catheter Related Pain: Visual Analog Score Rating
时间窗: post-op day 5-7
Catheter related pain was measured using a visual analog score rating mean post-operative pain on a scale from 1 (no pain) to 10 (worst possible pain). The lower the score the better the outcome.
次要结局
- Urinary Symptoms(week 12)
- Opioid Use(after discharge until post-op day 7)
- Patient Reported Number of Pads Used Per Day.(Week 12)
- Number of Participants Experiencing Bladder Neck Contracture(1 year)
- Quality of Life Score(Week 12)
- Number of Incontinence Pads Used(week 6)
- Home Opioid Use in Standard Morphine Equivalency(after discharge until post-op day 7)