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

Study Overview
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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.

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

Conditions
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Colorectal Anastomosis

Intervention / Treatment
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* Drug: TachoSil®


Participation Criteria
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Eligibility Criteria
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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?

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TachoSil®<br> | Drug: TachoSil®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor | 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. | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. | 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. | Day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Anastomosis, Colorectal Resection, Tachosil