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

Nycomed

Status and phase: Completed; Phase 2

Conditions: Colorectal Anastomosis

Treatments: Drug: TachoSil®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713661

2007-007254-62 (EudraCT Number)

TC-029-IM

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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?

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

TachoSil®

Experimental group

Treatment:

Drug: TachoSil®