Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations (ORP-SAC)
Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations - Open Label Randomized Pilot Study
Radical prostatectomy has become the gold standard treatment for prostate cancer.
Regarding of morbidity of access on open retropubic radical prostatectomy a lot of centers around the world start to develop laparoscopic and robotic approach over the past years. The problems regarding this techniques is that the pure laparoscopic prostatectomy shows a steep learning curve with a high initial complication rate, and the use of robotic assistance surgery despite of lower learning curve is associated with higher surgical supply and operative room costs. These costs may have a significant impact on overall cost of prostate cancer care especially in Brazil.
In Brazil, the open route for radical prostatectomy is still the most frequent approach. One of the disadvantages of open prostatectomy from the other surgeries is the longest hospital stay. However, the question of what length of stay after this operation is optimal and necessary is unresolved. In this trial the investigators have compared a randomized group of patients that had discharged on postoperative day 2, 1 and same day surgery. The investigators had intent to evaluate the feasibility of ambulatory open radical prostatectomy (patient discharge in the same day of surgery - average 12 hours of hospitalization) maintaining patient satisfaction and safety.
研究概览
地位
条件
详细说明
Radical prostatectomy initially described by Walsh (1982) has become the gold standard treatment for prostate cancer and has evolved enormously over the last 25 years. Improvements include the use of smaller incisions, reduced blood loss, shorter hospital stays, and surgical refinement. Several large series with long-term follow-up have confirmed that this approach results in excellent cancer control and functional results in terms of preservation of erectile potency and urinary continence.
Regarding of morbidity of access on open retropubic radical prostatectomy a lot of centers around the world start to develop laparoscopic and robotic approach over the past years. The problems regarding this techniques is that the pure laparoscopic prostatectomy shows a steep learning curve with a high initial complication rate, and the use of robotic assistance surgery despite of lower learning curve is associated with higher surgical supply and operative room costs. These costs may have a significant impact on overall cost of prostate cancer care especially in Brazil where nowadays only have 3 centers with 5 robots.
In Brazil, the open route for radical prostatectomy is still the most frequent approach, mainly out of large cities. One of the disadvantages of open prostatectomy from minimally invasive surgeries is the longest hospital stay. However, the question of what length of stay after this operation is optimal and necessary is unresolved. In this trial the investigators have compared a randomized group of patients that had discharged on postoperative day 2, 1 and same day surgery. The investigators had intent to evaluate the feasibility of ambulatory open radical prostatectomy (patient discharge in the same day of surgery - average 12 hours of hospitalization) while maintaining patient satisfaction and safety.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
São Paulo
-
Barretos、São Paulo、巴西、14784400
- Barretos' Cancer Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- clinically localized Prostate Cancer (PCa)
- underwent open radical retropubic prostatectomy at Barretos' Cancer Hospital by a single primary surgeon (EFF)
- patients which the procedure went without any complications
- body mass index ≤ 30 kg/m2
Exclusion Criteria:
- Important comorbidities
- history of bleeding diathesis
- taking blood thinners
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:patient discharge on postoperative day 2
The patient was discharge on postoperative day 2 (as was done routinely)
|
The patient was discharge on postoperative day 2 (as was done routinely)
|
|
实验性的:patient discharge on postoperative day 1
The patient was discharge on postoperative day 1
|
The patient was discharge on postoperative day 1
|
|
实验性的:patient discharge in the day of surgery
The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)
|
The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of ambulatory open radical prostatectomy while maintaining patient satisfaction and safety.
大体时间:2 weeks postoperatively
|
The endpoint regarding the survey is the comparison with standard group discharged at postoperative day 2. The satisfaction was considered non similar when there were more than 1 negative answer for any question or any patient in comparison to standard group in these questions: Do you consider your postoperative care adequate ?
/ Was your understanding of the necessary postoperative care adequate before enrolling for this study?
Was your pain control adequate?
/ Was the length of hospitalization adequate?
/ Would you choose to have the procedure again with the same length of hospitalization?
/ Did you take any analgesic postoperatively after being discharged?
/ Did you take any analgesic postoperatively after being discharged?
/ Have you received adequate medical and nurse's care during the post-operative period?
/ Did you consider the access to the hospital easy if you needed it?
/ Would you recommend other men undergo this procedure the same way you?
|
2 weeks postoperatively
|
合作者和调查者
调查人员
- 首席研究员:Igor RM Franklin, MD、Barretos' Cancer Hospital
- 学习椅:Eliney F Faria, PhD、Barretos' Cancer Hospital
- 研究主任:Wesley J Magnabosco, MD、Barretos' Cancer Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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