Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
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|ClinicalTrials.gov Identifier: NCT00713661|
Recruitment Status : Completed
First Posted : July 11, 2008
Results First Posted : March 2, 2012
Last Update Posted : May 8, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Anastomosis||Drug: TachoSil®||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-randomised, Open, Multi-center Trial Evaluating Feasibility and Safety of TachoSil® Application on a Colorectal Anastomosis.|
|Study Start Date :||June 2008|
|Primary Completion Date :||June 2009|
|Study Completion Date :||July 2010|
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.
- The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor [ Time Frame: Day of surgery ]Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.
- The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. [ Time Frame: Day of surgery ]Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713661
|Dartford, Kent, United Kingdom|
|Study Chair:||Nycomed Clinical Trial Operations||Headquarters|