NCT01121601

CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion

Effectiveness and Tolerance of CoSeal in the Prevention of Hepatic Adherences of Novo Post Operational Within the Framework of a Hepatic Surgery of Resection in Two Times for Hepatic Metastases: Study of Phase II/III.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Study of phase II: Clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 Study of phase III: Clinical study national, multicentric, prospective, randomized, controlled, as a double blind man comparing a group controls with a group of patients treated by a surgical gel of sealing containing polyethylene glycol in the prevention of hepatic adherences of novo post operational.

Conditions

• Patient With Hepatic Metastasis

Interventions

Type	Name	Description
PROCEDURE	hepatic surgery of resection	after metastasis liver resection , Coseal will be administered at 4 mL by dose, administration of 1 to 3 dose in fontion of liver adherence Coseal will be administered by spray at 5 to 10 cm of liver.
PROCEDURE	hepatic surgery of resection	this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group

Timeline

• Start date: 2011-08-01
• First posted: 2010-05-12
• Last updated: 2015-08-06

Locations

1 site across 1 country: France