Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe.

The secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nycomed

Criteria

Inclusion Criteria - at screening:

• Has the patient 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 above?

• Is the subject scheduled for elective resection of the rectum?

• Is a colorectal anastomosis below the peritoneal reflexion planned?

For females of childbearing potential:

• 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))?

• Is the blood or urine pregnancy test negative?

Exclusion Criteria -at screening:

• Is the subject scheduled for emergency resection of the rectum?

• Does the subject suffer from inflammatory bowel diseases?

• Does the subject have a history of hypersensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?

• Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial?

• Does the subject participate or plan to participate in another clinical trial during the trial period?

For females of childbearing potential:

• Is the subject pregnant or breast feeding?

Exclusion - peroperative

• Was an anastomosis performed differently from what was defined in the inclusion criteria?

• Did the subject receive any fibrin sealant/glue, excluding TachoSil® , during surgery?