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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hernia, Abdominal, Hernia,Ventral

Intervention / Treatment
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* Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
* Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
* Device: Ventralight ST implant
* Device: ETHICON PHYSIOMESH®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PH<br>Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device. | Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.<br>* 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)<br>* Other names: ETHICON SECURESTRAP® Fixation Device;Device: ETHICON PHYSIOMESH®<br> <br> |
| Active Comparator: VS<br>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 Ventralight ST implant with SorbaFix fixation device.<br>* 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)<br>* Other names: SORBAFIX™Absorbable Fixation System;Device: Ventralight ST implant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Presence of pain 7 days after the surgery. | 7 days after the surgery | 
| Pain | Presence of pain 3 months after the surgery. | 3 months after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Recurrences | The recurrence rate in one year followup. | up to one year | 
| Number of Participants with complications. | The description and percentage distribution of short and long term complications following surgery. | up to one year | 
| Pain intensity | Intensity of pain measured on a visual analogue scale 7 days after the surgery | 7 days after the surgery | 
| Pain intensity | Intensity of pain measured on a visual analogue scale 30 days after the surgery | 30 days after the surgery | 
| Pain intensity | Intensity of pain measured on a visual analogue scale 3 months after the surgery. | 3 months after the surgery | 
| Pain intensity | Intensity of pain measured on a visual analogue scale 6 months after the surgery. | 6 months after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic hernia repair, Ventral hernia, Incisional hernia, IPOM