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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
at the end of surgery
Ghent University Hospital
Ghent, Belgium
development of a radiographic lymphocele on abdominal ultrasonography
Time frame: at week 1 post-surgery
volume of radiographic lymphoceles
Time frame: at week 1 post-surgery
duration of postoperative drainage catheter
Time frame: Daily during standard postoperative care until removal of the catheter, with an expected average of 1 day.
volume produced by postoperative drainage catheter (lymphorrhea)
Time frame: Daily during standard postoperative care until removal of the drain, with an expected average of 1 day.
time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation).
specific for bladder cancer
Time frame: 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.
development of a radiographic lymphocele on abdominal ultrasonography
Time frame: at week 4 post-surgery
volume of radiographic lymphoceles
Time frame: at week 4 post-surgery
development of a symptomatic lymphocele.
Time frame: at week 1 post-surgery
decrease in serum hemoglobin on the first postoperative day
Time frame: at week 1 post-surgery
duration of hospital stay
Time frame: at week 1 post-surgery
total cost
Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.
Time frame: at week 1 post-surgery
development of a symptomatic lymphocele.
Time frame: at week 4 post-surgery
decrease in serum hemoglobin on the first postoperative day
Time frame: at week 4 post-surgery
duration of hospital stay
Time frame: at week 4 post-surgery
total cost
Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.
Time frame: at week 4 post-surgery
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