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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TachoSil	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
NO_INTERVENTION: No TachoSil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
development of a radiographic lymphocele on abdominal ultrasonography		at week 1 post-surgery
volume of radiographic lymphoceles		at week 1 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.
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	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		at week 4 post-surgery
volume of radiographic lymphoceles		at week 4 post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
development of a symptomatic lymphocele.		at week 1 post-surgery
decrease in serum hemoglobin on the first postoperative day		at week 1 post-surgery
duration of hospital stay		at week 1 post-surgery
total cost	Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.	at week 1 post-surgery
development of a symptomatic lymphocele.		at week 4 post-surgery
decrease in serum hemoglobin on the first postoperative day		at week 4 post-surgery
duration of hospital stay		at week 4 post-surgery
total cost	Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.	at week 4 post-surgery

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Takeda
• Investigators: Principal Investigator: Nicolaas Lumen, MD, PhD, FEBU, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: November 28, 2013
• First Posted (ESTIMATE): December 5, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: undergoing; pelvic; lymph; node; patients,; dissection.
• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Cysts; Urinary Bladder Neoplasms; Lymphocele; Coagulants; Hemostatics
• Other Study ID Numbers: EC/2013/472; 2013-000782-36 (EUDRACT_NUMBER)