NCT02001857

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate or Bladder Cancer

Interventions

Type	Name	Description
DRUG	1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.	at the end of surgery

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-02-01
• Completion: 2017-08-01
• First posted: 2013-12-05
• Last updated: 2017-08-25

Locations

1 site across 1 country: Belgium