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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Colorectal Anastomosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TachoSil®

Group Type EXPERIMENTAL

TachoSil®

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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?

* Did the subject receive any fibrin sealant/glue, excluding TachoSil® , during surgery?

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No