Efficacy and safety of TachoSil in patients undergoing cystectomy. A pilot study. - TachoSil in urological surgery
- Conditions
- 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: 9.1Level: LLTClassification code 10005003Term: Bladder cancer
- Registration Number
- EUCTR2007-003622-18-DK
- Lead Sponsor
- State University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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®
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method