Assessment of Long-term Effects of Tachosil

Assessment of Long-term Effects of Intraoperative Use of a Carrier-bound Fibrin Sealant (TachoSil®). We Had to Continue to Use it?

This study aimed to analyse the long-term effects of a carrier-bound fibrin sealant (CBFS) after abdominal surgery by following up patients years after application.

Study Overview

• Status: Completed
• Conditions: Haemostasis; Fibrin Sealant
• Intervention / Treatment: Device: TachoSil®

• Study Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years.

The indications for surgery were hepatocellular carcinoma 23 (57.5%), hydatid cyst 3 (7.5%), hepatic adenoma 1 (2.5%), hepatic trauma 2 (5.0%), cholecystitis 2 (5.0%), 3 (7.5%), splenic rupture or bleeding for trauma 1 (2.5%), neuroendocrine tumour and trauma of the pancreas 1 (2.5%), peptic gastric ulcer 3 (7.5%), and colon cancer 1 (2.5%).

There were 29 hepatic surgical procedures: 4 left lobectomies, 2 right hepatectomies, 9 segmentectomies, 2 bi-segmentectomies, 8 limited resections, and 1 enucleation following the Couinaud classification (23); 2 partial cystopericistectomies, 1 simple suture of the traumatic lobe of the liver after biliary check; 2 cholecystectomies, 3 total splenectomies, 1 enucleation of tumour of the tail of the pancreas, 1 haemostasis of the traumatic tail of the pancreas, 3 sutures of ulcer of the stomach, and 1 colon cancer resection.

Description

Inclusion Criteria:

• type of surgery, indication for surgery, type of disease

Exclusion Criteria:

• dead patients, not available on call.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
40 patients; There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years.	Device: TachoSil®; TachoSil®, a carrier-bound fibrin sealant (CBFS), is a haemostatic tissue sealant composed of a collagen sponge, made from horse tendons, coated on one side with dried human fibrinogen and human thrombin.; Other Names: haemostatic tissue sealant; carrier-bound fibrin sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fibrotic reaction	The evaluation focused on individuation of the area treated with CBFS, comprehensive analysis of the dimensions of the area treated if visible, and evolution, focusing on the presence of fibrosis, sclerosis, collections, cysts, or pseudocysts. The formation of a fibrotic reaction was related to the presence of residual tissue on CT during follow-up.	10 years

Collaborators and Investigators

• Sponsor: University of Catania

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coagulants; Fibrin Tissue Adhesive; Hemostatics
• Other Study ID Numbers: IDC-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes