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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nycomed
ClinicalTrials.gov Identifier:
NCT00713661
First received: July 7, 2008
Last updated: May 4, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Colorectal Anastomosis
Drug: TachoSil®
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-randomised, Open, Multi-center Trial Evaluating Feasibility and Safety of TachoSil® Application on a Colorectal Anastomosis.

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: June 2008
Study Completion Date: July 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TachoSil® 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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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?
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713661

Locations
Germany
Investigational site
Berlin, Germany
Netherlands
Investigational site
Utrecht, Netherlands
United Kingdom
Investigational site
Dartford, Kent, United Kingdom
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquarters
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00713661     History of Changes
Other Study ID Numbers: TC-029-IM, 2007-007254-62
Study First Received: July 7, 2008
Results First Received: December 20, 2011
Last Updated: May 4, 2012
Health Authority: Germany: Ethics Commission
The Netherlands:
United Kingdom:

Keywords provided by Nycomed:
Colorectal Anastomosis
Colorectal Resection
Tachosil

ClinicalTrials.gov processed this record on November 20, 2014