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

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.

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Key information

Conditions

Colorectal Anastomosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

TachoSil®

Drug

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.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Jul 11, 2008
Registry last updated: May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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