The trial will evaluate the efficacy and safety of TachoSil in patients undergoing cystectomy for bladder cancer and non-malignant bladder disease. TachoSil will be applied to the anastomoses between the ureters and the new bladder made of an isolated intestinal loop. The purpose of applying TachoSil to the anastomoses is to evaluate whether this treatment will reduce the degree of stenosis in the anastomoses and thus reduce the degree of impairment on the renal function. MedDRA version: 9.1 Le
Conditions
Interventions
Trade Name: TachoSil
Product Name: TachoSil
Product Code: Local haemostatic
Pharmaceutical Form: Impregnated dressing
Other descriptive name: HUMAN FIBRINOGEN
Concentration unit: mg milligram(s)
Conce
Sponsors
State University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Has the subject given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the subject. Is the subject 18 years of age or older ? Is the patient scheduled for elective cystectomy for any reason? Normal renal function by renography 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who have previously undergone any surgery on the bladder Previous radiation therapy Previous chemotherapy Final stage patients with a life expectancy of less than 3 months Patients with diabetes Patients with a history of or expected delay in disturbances in wound healing Known or suspected allergy to any of the components in TachoSil®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to evaluate the efficacy and safety of the medicinal product TachoSil® to reduce the degree of stenosis of the ureteres in patients undergoing radical cystectomy for bladder cancer and non-malignant conditions. As TachoSil® is not registered for this use, a pilot study is chosen as an initial evaluation of the use in urological surgery. The primary measurement will be assessment of kidney function at follow up relative to kidney function at inclusion. Kidney function will be evaluated by means of intravenous renography and GFR (glomerular filtration rate). A reduction in kidney function of ? 10% in one side measured by renography will be regarded as indicative of ureteral stenosis and a reduction of GFR ? 25% will indicate bilateral reduction/stenosis. . The kidney function will be assessed by intravenous renography and Glomerular Filtration Rate (GRF) at follow up after 2-3 months and 1 year after discharge. ;Secondary Objective: Secondary end points Number of patients undergoing re-operation. Number of patients receiving stent following surgery. ;Primary end point(s): The primary measurement will be assessment of kidney function at follow up relative to kidney function at inclusion. Kidney function will be evaluated by means of intravenous renography and GFR (glomerular filtration rate). A reduction in kidney function of ? 10% in one side measured by renography will be regarded as indicative of ureteral stenosis and a reduction of GFR ? 25% will indicate bilateral reduction/stenosis. . The kidney function will be assessed by intravenous renography and Glomerular Filtration Rate (GRF) at follow up after 2-3 months and 1 year after discharge. These two tests are chosen for evaluation of kidney function as they are the tests with a high level of evidence. All patients with reduced kidney function shown in one or both tests will be evaluated whether the reduction is caused by stenosis or other reasons (infect | — |
Countries
Denmark
Outcome results
None listed