TachoSil in urological surgery

ABSTRACT: Primary objectives: 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. Primary endpoints: 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 (infections etc.).

DISEASE(S): 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.,Bladder Cancer

PROVIDER: 2522613 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR