Effect of TachoSil® on incidence of symptomatic and radiographic lymphoceles after extended pelvic lymph node dissection in prostate and bladder cancer.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000782-36-BE

Enrollment

200

Registered

2013-06-14

Start date

2013-08-13

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

Patients with prostate cancer or bladder cancer, undergoing transperitoneal pelvic lymph node dissection. MedDRA version: 14.1 Level: LLT Classification code 10057890 Term: Lymph node dissection System Organ Class: 100000004865

Interventions

Trade Name: TachoSil medicinale spons Product Name: TachoSil® Pharmaceutical Form: Medicated sponge INN or Proposed INN: active part of TachoSil CAS Number: 9001-32-5 Other descriptive name: HUMAN FI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age > 18 years old - Diagnosis of prostate cancer or bladder cancer on pathology - Undergoing transperitoneal pelvic lymph node dissection. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: - Previous pelvic surgery or irradiation. - Any type of clotting disorder.

Design outcomes

Primary

Measure	Time frame
Main Objective: To prospectively measure the effect of TachoSil® on development of symptomatic and radiographic lymphoceles following pelvic lymph node dissection in prostate and bladder cancer patients.;Secondary Objective: Assessment of cost effectiveness of using TachoSil® on development of symptomatic and radiographic lymphoceles following pelvic lymph node dissection in prostate and bladder cancer patients.;Primary end point(s): - development of a radiographic lymphocele - volume of radigraphic lymphoceles - duration of postoperative drainage catheter - volume produced by postoperative drainage catheter (lymphorrea) - specific for bladder cancer: time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation). ;Timepoint(s) of evaluation of this end point: Evaluation during 1 month after surgery.	—

Measure

Time frame

Main Objective: To prospectively measure the effect of TachoSil® on development of symptomatic and radiographic lymphoceles following pelvic lymph node dissection in prostate and bladder cancer patients.;Secondary Objective: Assessment of cost effectiveness of using TachoSil® on development of symptomatic and radiographic lymphoceles following pelvic lymph node dissection in prostate and bladder cancer patients.;Primary end point(s): - development of a radiographic lymphocele - volume of radigraphic lymphoceles - duration of postoperative drainage catheter - volume produced by postoperative drainage catheter (lymphorrea) - specific for bladder cancer: time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation). ;Timepoint(s) of evaluation of this end point: Evaluation during 1 month after surgery.

—

Secondary

Measure	Time frame
Secondary end point(s): - development of a symptomatic lymphocele. - decrease in serum hemoglobin on the first postoperative day - duration of hospital stay - total cost (surgical procedure, hospitalization and possible complications up to the first month post-surgery). ;Timepoint(s) of evaluation of this end point: Evaluation during 1 month after surgery.	—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

Bimetra.Clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026