on-randomised, open, multi-center trial evaluating feasibility and safety of TachoSil application on a colorectal anastomosis. - Evaluation of TachoSil application on a colorectal anastomosis.
- Conditions
- The scope of this trial is to evaluate if it is possible to apply TachoSil around colorectal anastomosis and evaluate its feasibility in future clinical trials. Therefore the only focus is on the validation of the TachoSil application method.
- Registration Number
- EUCTR2007-007254-62-DE
- Lead Sponsor
- ycomed Danmark ApS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
1. Has the patient given informed consent according to local requirements before any trialrelated activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject
2. Is the subject 18 years of age or above?
3. Is the subject scheduled for elective resection of the rectum?
4. Is a colorectal anastomosis below the peritoneal reflexion planned?
For females of childbearing potential:
5. Does the patient use an acceptable contraceptive method (contraceptive pills, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices, transdermal patches or intrauterine device (IUD))?
6. Is the blood or urine pregnancy test negative?
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
1. Is the subject scheduled for emergency resection of the rectum?
2. Does the subject suffer from inflammatory bowel diseases?
3. Does the subject have a history of hypersensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
4. Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial?
5. Does the subject participate or plan to participate in another clinical trial during the trial period?
For females of childbearing potential:
6. Is the subject pregnant or breast feeding?
Exclusion - peroperative
7. Was an anastomosis performed differently from what was defined in the inclusion
criteria?
8. Did the subject receive any fibrin sealant/glue, excluding TachoSil®, during surgery?
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