Phase 2
N=25
Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
Colorectal Anastomosis
Bottom Line
View on ClinicalTrials.gov: NCT00713661 ↗Enrolled (actual)
25
Serious AEs
28.0%
Results posted
Mar 2012
Primary outcome: Primary: The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor — 1; 2; 1; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TachoSil® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nycomed
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor |
1; 2; 1; 2; 2; 5 | — |
| SECONDARY The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator. |
6; 9; 4; 5; 1; 0 | — |
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?
Data sourced from ClinicalTrials.gov (NCT00713661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.