NCT00713661

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

Non-randomised, Open, Multi-center Trial Evaluating Feasibility and Safety of TachoSil® Application on a Colorectal Anastomosis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Nycomed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Anastomosis

Interventions

Type	Name	Description
DRUG	TachoSil®	Sterile, ready-to-use, absorbable sponge for intra-operative topical application. It consists of an equine collagen sponge coated with the fibrin glue components human fibrinogen and human thrombin. Surgery was performed according to the hospitals' local standards. When the anastomosis was performed, all enrolled subjects had TachoSil® applied around the anastomotic line. TachoSil® was therefore an add-on therapy.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-06-01
• Completion: 2010-07-01
• First posted: 2008-07-11
• Last updated: 2012-05-08
• Results posted: 2012-03-02

Locations

3 sites across 3 countries: Germany, Netherlands, United Kingdom