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

Not Applicable

Terminated

• Conditions: Hernia,Ventral; Hernia, Abdominal
• Interventions: 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: Ventralight ST implant; Device: ETHICON PHYSIOMESH®

• Registration Number: NCT02233569
• Lead Sponsor: Polish Hernia Study Group

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-08-29
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-05
• Last Update Submitted: 2014-09-05
• Study First Posted: 2014-09-08
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VS	Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.	Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
PH	Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.	Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
VS	Ventralight ST implant	Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
PH	ETHICON PHYSIOMESH®	Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.

Primary Outcome Measures

Name	Time	Method
Pain	3 months after the surgery	Presence of pain 3 months after the surgery.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Recurrences	up to one year	The recurrence rate in one year followup.
Number of Participants with complications.	up to one year	The description and percentage distribution of short and long term complications following surgery.
Pain intensity	6 months after the surgery	Intensity of pain measured on a visual analogue scale 6 months after the surgery.

Trial Locations

Locations (1)

Ceynowa Hospital; 🇵🇱 Wejherowo, Pomorskie, Poland