Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
2021年4月8日 更新者：Ahmed Abdelbary Ali、Cairo University
Randomised Controlled Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center
This study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at National Cancer Institute; Cairo University.
研究概览
详细说明
The study will randomise 60 patients to one of two arms; laparoscopic-assisted radical cystectomy and open radical cystectomy.
The focus of the study will be a comparison of both approaches on the patients' peri-operative outcome.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Cairo、埃及、11796
- National Cancer Institute
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma.
- Patients fit for surgery (ECOG Performance Status 0,1).
Exclusion Criteria:
- Patients with medical comorbidities that preclude surgical management or minimally invasive techniques.
- Patients with advanced hydronephrosis or renal failure.
- Patients refusing surgery.
- Patients with urinary bladder cancer invading bladder neck or prostatic urethra.
- Patients with metastatic urinary bladder cancer.
- Patients who received prior pelvic radiotherapy.
- Patients refusing randomization and/or participation in the trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：并行分配
- 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：Open Radical Cystectomy
Standard open radical cystectomy.
|
Standard open radical cystectomy and urinary diversion
|
|
实验性的：Laparoscopic-assisted radical cystectomy.
|
Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion
|
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 |
|---|---|---|
|
Operative time
大体时间：During surgery
|
OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion.
|
During surgery
|
|
Blood loss
大体时间：During surgery
|
EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs.
|
During surgery
|
|
Length of hospital stay
大体时间：Immediate post-operative period.
|
LOS as measured in days
|
Immediate post-operative period.
|
|
Time to oral intake
大体时间：Immediate post-operative period
|
Measured in days
|
Immediate post-operative period
|
|
Conversion rate
大体时间：During surgery
|
Rate of conversion from laparoscopy to open surgery
|
During surgery
|
|
Re-admission rate.
大体时间：Intra-operative to sixth months.
|
Re-hospitalization requirement.
|
Intra-operative to sixth months.
|
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Opioid requirements.
大体时间：During surgery through first post-operative week.
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Requirement, dose and duration of narcotic analgesia.
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During surgery through first post-operative week.
|
|
Visceral injury
大体时间：During surgery
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Any organ injury encountered during the operation.
|
During surgery
|
|
Urine leak
大体时间：Up to 4 weeks
|
Leakage of urine from urinary enteric anastomosis
|
Up to 4 weeks
|
|
Wound dehiscence, infection.
大体时间：Up to 4 weeks
|
Wound gaping, evisceration or infection.
|
Up to 4 weeks
|
|
Enteric fistula
大体时间：Up to 4 weeks
|
Leakage of intestinal contents due to failure of entero-enteric anastomosis
|
Up to 4 weeks
|
|
Sepsis
大体时间：Up to 4 weeks
|
Infection triggering a systematic immune response
|
Up to 4 weeks
|
|
Venous thromboembolism
大体时间：Up to 2 months
|
DVT or pulmonary embolism
|
Up to 2 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
pT stage
大体时间：Within 10 days post surgery.
|
Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4)
|
Within 10 days post surgery.
|
|
Lymph node retrieval
大体时间：Within 10 days post surgery.
|
Number of lymph nodes retrieved by open versus laparoscopic approaches.
|
Within 10 days post surgery.
|
|
pN stage
大体时间：Within 10 days post surgery.
|
Lymph node metastasis (positive or negative), and number of positive nodes if present.
|
Within 10 days post surgery.
|
|
Surgical margins
大体时间：Within 10 days post surgery
|
Positive margins or negative margins.
Location of positive margins (Urethral, ureteric)
|
Within 10 days post surgery
|
|
Histological grade
大体时间：Within 10 days post surgery
|
Low grade, intermediate grade or high grade
|
Within 10 days post surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Hatem Aboulkassem, M.D., Ph.D.、National Cancer Institute, Cairo University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年1月24日
初级完成 (实际的)
2019年7月1日
研究完成 (实际的)
2020年12月30日
研究注册日期
首次提交
2021年3月30日
首先提交符合 QC 标准的
2021年4月8日
首次发布 (实际的)
2021年4月9日
研究记录更新
最后更新发布 (实际的)
2021年4月9日
上次提交的符合 QC 标准的更新
2021年4月8日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.