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

Polish Hernia Study Group

Status

Terminated

Conditions

Hernia,Ventral

Hernia, Abdominal

Treatments

Device: Ventralight ST implant

Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.

Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.

Device: ETHICON PHYSIOMESH®

Study type

Interventional

Funder types

Other

Identifiers

NCT02233569

PHvsVS

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Informed Consent Form (ICF) signed by the patient or his/her legal representative
primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair
recurrence after former abdominal hernia repair WITH MESH
recurrence after suture abdominal hernia repair CAN be included

Exclusion criteria

no written informed consent
patient under 18 years old
emergency surgery (incarcerated hernia)
patients with expected life time shorter than one year for example due to generalised malignancy
BMI exceeding 40.0kg/m²
contaminated surgical fields
patients on immunosuppression, steroid therapy, constant pain therapy