Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
Conditions
Prostate or Bladder Cancer
Conditions: official terms
Lymphocele - Urinary Bladder Neoplasms
Conditions: Keywords
patients,, undergoing, pelvic, lymph, node, dissection.
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Intervention
Name: 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Ghent University Hospital
Ghent, Belgium
Status: Recruiting
Start Date
September 2013
Completion Date
October 2015
Sponsors
University Hospital, Ghent
Source
University Hospital, Ghent
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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