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

Phase 1

• Conditions: Patients with prostate cancer or bladder cancer, undergoing transperitoneal pelvic lymph node dissection.; MedDRA version: 14.1Level: LLTClassification code 10057890Term: Lymph node dissectionSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2013-000782-36-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-14
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• 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.

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- volume of radigraphic lymphoceles<br>- duration of postoperative drainage catheter<br>- volume produced by postoperative drainage catheter (lymphorrea)<br>- 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).<br>;Timepoint(s) of evaluation of this end point: Evaluation during 1 month after surgery.

Secondary Outcome Measures

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