Applicability of TachoSil® in sealing rectal anastomoses. A feasibility trial. - Sealing of colorectal anastomoses with TachoSil®

• Conditions: Sealing of rectal anastomoses following surgery for colo-rectal cancer.; MedDRA version: 9.1Level: LLTClassification code 10061451Term: Colorectal cancer

• Registration Number: EUCTR2006-003349-17-DK
• Lead Sponsor: Hvidovre Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Informed written consent
Age 18 years or above
Elective surgery with intended anastomosis following resection for rectum cancer
Establishment of rectal anastomoses with the use of a stapler
Use of adequate contraception in females of childbearing potential

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of allergic reactions after applications of human fibrinogen, human thrombin and/or collagen of any origin
Emergency operation.
Pregnancy or breastfeeding.
Participation in a clinical trial less than 30 days prior to inclusion in present trial.
Participation in a clinical trial concomitantly with present trial.

After laparotomy:

Use of any fibrin glue apart from TachoSil® for sealing of the anastomoses. TachoSil® may be used for haemostasis in the case of haemorrhage from parenchymatous organs, however.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to establish a procedure for the application of TachoSil® following establishment of rectal anastomoses. For this purpose a number of no more than15 patients will be included who will all have TachoSil® applied to their rectal anastomoses. If data from less than 15 patients are sufficient to establish a procedure for application of TachoSil® the trial will be stopped before 15 patients are included for evaluation. ;Secondary Objective: None;Primary end point(s): The primary end point is to validate the application procedure for TachoSil on rectal anastomoses.