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.
Conditions
Interventions
Trade Name: TachoSil
Pharmaceutical Form:
INN or Proposed INN: Human Fibrinogen
Concentration unit: mg milligram(s)
Concentration number: 5.5-mg/cm2
INN or Proposed INN: Human Thrombin
Concentratio
Sponsors
Nycomed Danmark ApS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate if the application of TachoSil on a colorectal anastomosis is feasible and safe.;Secondary Objective: The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.;Primary end point(s): The primary efficacy variable is whether or not the TachoSil application is feasible. | — |
Countries
Germany, Netherlands, United Kingdom
Outcome results
None listed