Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation).
研究概览
简要总结
Pelvic lymph node dissection (PLND) is the most accurate staging tool to determine lymph node involvement in prostate and bladder cancer. The main complication of PLND is development of a lymphocele, which can cause symptoms including lower abdominal pain, leg or penile/scrotal edema, bladder outlet obstruction, deep venous thrombosis or infection/sepsis. The incidence of radiographic (asymptomatic) and symptomatic lymphoceles following PLND varies between 12,6-63% and 1,6-33% respectively. Medicated sponges such as Tachosil® are indicated in surgery for improvement of haemostasis and to promote tissue sealing. They could reduce lymphocele development by increased tissue sealing, due to a mechanical effect of the sponge itself and a lymphostatic effect of the included thrombin and fibrinogen. Our goal is to prospectively assess the lymphostatic effect of Tachosil(r) in patients undergoing transperitoneal PLND with or without radical prostatectomy or PLND with bladder cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Diagnosis of prostate cancer or bladder cancer on pathology
- •Undergoing transperitoneal pelvic lymph node dissection.
排除标准
- •Previous pelvic surgery or irradiation.
- •Any type of clotting disorder.
研究组 & 干预措施
TachoSil
TachoSil
干预措施: 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery. (Drug)
结局指标
主要结局
time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation).
时间窗: Daily during standard postoperative care up to date of first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation), with an expected average of 1 day.
specific for bladder cancer
development of a radiographic lymphocele on abdominal ultrasonography
时间窗: at week 4 post-surgery
volume of radiographic lymphoceles
时间窗: at week 4 post-surgery
duration of postoperative drainage catheter
时间窗: Daily during standard postoperative care until removal of the catheter, with an expected average of 1 day.
volume produced by postoperative drainage catheter (lymphorrhea)
时间窗: Daily during standard postoperative care until removal of the drain, with an expected average of 1 day.
次要结局
- decrease in serum hemoglobin on the first postoperative day(at week 4 post-surgery)
- development of a symptomatic lymphocele.(at week 4 post-surgery)
- duration of hospital stay(at week 4 post-surgery)
- total cost(at week 4 post-surgery)