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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003349-17-DK

Enrollment

Registered

2007-07-03

Start date

2007-08-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sealing of rectal anastomoses following surgery for colo-rectal cancer. MedDRA version: 9.1 Level: LLT Classification code 10061451 Term: Colorectal cancer

Interventions

Trade Name: TachoSil Product Name: TachoSil Product Code: B02B C Pharmaceutical Form: Medicated sponge

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026