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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02001857

Enrollment

200

Registered

2013-12-05

Start date

2013-09-30

Completion date

2017-08-31

Last updated

2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate or Bladder Cancer

Keywords

patients,, undergoing, pelvic, lymph, node, dissection.

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.

Interventions

DRUG1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.

at the end of surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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 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.	—

Secondary

Measure	Time frame	Description
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	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.	at week 1 post-surgery	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026