NCT02233569

Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair

COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Polish Hernia Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.

Conditions

• Hernia, Abdominal
• Hernia,Ventral

Interventions

Type	Name	Description
PROCEDURE	Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.	Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Physiomesh (mesh implant) and Securestrap (fixation device)
PROCEDURE	Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.	Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Ventralight ST (mesh implant) and SofbaFix (fixation device)
DEVICE	Ventralight ST implant
DEVICE	ETHICON PHYSIOMESH®

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2014-09-08
• Last updated: 2014-09-08

Locations

1 site across 1 country: Poland