Lymph Node Dissection Before or After Cystectomy - Pilot Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Bladder Cancer
- 发起方
- Jagiellonian University
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Early complications rate
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
The purpose of this study is to compare different ways of performing surgery for bladder cancer. Specifically, the goal is to determine whether it is better to remove the lymph nodes before removing the bladder or after removing the bladder during radical cystectomy.
The study aims to answer two main questions:
- Does the order of surgical steps during radical cystectomy affect the occurrence of complications after surgery?
- Does the order of surgical steps during radical cystectomy impact the duration of the operation and the number of lymph nodes removed?
Participants in the study will be randomly assigned to one of two groups. One group will undergo lymph node removal before bladder resection, while the other group will have lymph node removal after bladder resection during radical cystectomy.
Throughout their hospital stay and for 30 days following the operation, participants will be closely monitored for various factors including operative details, pathology results, and any complications that may arise.
详细描述
Lymph node dissection (LND) is an integral part of radical cystectomy (RC) for bladder cancer. LND provides important diagnostic and prognostic information, and according to most studies, is associated with therapeutic benefit. The optimal extent and template for LND in bladder cancer remains to be established. Currently, there are no specific recommendations regarding the sequence of lymph nodes removal and bladder resection during radical cystectomy, and the decision is based mainly on individual surgeon preference. The aim of the LBOAC pilot randomized trial is to evaluate the difference in intraoperative parameters and postoperative outcomes between patients undergoing LND before bladder resection during RC and those undergoing LND after bladder resection during RC. LBOAC is a pilot randomized controlled trial with two parallel groups. The primary objective of the trial is the comparison of complication rate within 30 postoperative days. Secondary objectives of LBOAC include comparing lymph node yield and operative time between the two groups. Data for will be collected using electronic case report forms (eCRFs) at baseline and within 30 days after the surgery. This pilot study is designed to test feasibility of, to support the refinements of the protocol and to aid in sample calculation that can be used for larger scale trial.
研究者
Anna K. Czech, MD
Principal Investigator
Jagiellonian University
入排标准
入选标准
- •Patients undergoing radical cystectomy for bladder cancer in the Department of Urology University Hospital in Krakow
排除标准
- •Previous pelvic lymph node dissection
结局指标
主要结局
Early complications rate
时间窗: Within 30 days after the surgery
Complications rate within 30 postoperative days
次要结局
- Lymph node yield(When pathology report is available (on average, the pathology report is available within 14 days after the surgery))
- Operative time(At the end of the surgery (after the completion of skin closure and wound dressing))