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

Phase 4

Completed

• Conditions: Prostate or Bladder Cancer
• Interventions: Drug: 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.

• Registration Number: NCT02001857
• Lead Sponsor: University Hospital, Ghent

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 Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-11-28
• Study First Posted: 2013-12-05
• Primary Completion: 2017-02
• Status Verified: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age > 18 years old
• Diagnosis of prostate cancer or bladder cancer on pathology
• Undergoing transperitoneal pelvic lymph node dissection.

Exclusion Criteria

• Previous pelvic surgery or irradiation.
• Any type of clotting disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TachoSil	1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.	TachoSil

Primary Outcome Measures

Name	Time	Method
time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation).	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	at week 4 post-surgery
volume of radiographic lymphoceles	at week 4 post-surgery
duration of postoperative drainage catheter	Daily during standard postoperative care until removal of the catheter, with an expected average of 1 day.
volume produced by postoperative drainage catheter (lymphorrhea)	Daily during standard postoperative care until removal of the drain, with an expected average of 1 day.

Secondary Outcome Measures

Name	Time	Method
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	Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium