Clinical trial NCT00713661: Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
Official title: Non-randomised, Open, Multi-center Trial Evaluating Feasibility and Safety of TachoSil® Application on a Colorectal Anastomosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Anastomosis
Keywords: Colorectal Anastomosis
Colorectal Resection
Tachosil
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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?

Primary outcomes:
measure: The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor
timeFrame: Day of surgery
Secondary outcomes:
measure: The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigational site
city: Utrecht
country: Netherlands
facility: Investigational site
city: Dartford
country: United Kingdom
facility: Investigational site
state: Kent
Study officials:
affiliation: Headquarters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References: