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

Phase 2

Completed

• Conditions: Colorectal Anastomosis
• Interventions: Drug: TachoSil®

• Registration Number: NCT00713661
• Lead Sponsor: Nycomed

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-10
• Study First Posted: 2008-07-11
• Primary Completion: 2009-06
• Study Completion: 2010-07
• Results First Submitted: 2011-12-20
• Status Verified: 2012-02
• Results First Submitted QC: 2012-02-01
• Results First Posted: 2012-03-02
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TachoSil®	TachoSil®	-

Primary Outcome Measures

Name	Time	Method
The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor	Day of surgery	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.

Secondary Outcome Measures

Name	Time	Method
The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.	Day of surgery	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.

Trial Locations

Locations (1)

Investigational site; 🇬🇧 Dartford, Kent, United Kingdom