Clinical Trial: Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.

Brief Summary: 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.

Detailed Summary:
Sponsor: University Hospital, Ghent

Current Primary Outcome:

  • 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). [ 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. ]
    specific for bladder cancer
  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: at week 1 post-surgery ]
    Total cost includes: surgical procedure, hospitalization and possible complications up to the first month 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 [ Time Frame: at week 4 post-surgery ]
    Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.


Original Secondary Outcome: Same as current

Information By: University Hospital, Ghent

Dates:
Date Received: October 28, 2013
Date Started: September 2013
Date Completion: October 2016
Last Updated: April 8, 2016
Last Verified: April 2016