Preperitoneal Umbilical Mesh Area

Study Overview
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Brief Summary
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The aim of this study is to measure the mesh shrinkage and the visualization of the mesh with MRI scan at 1 month and 13 months after robot assisted preperitoneal hernia repair using the visible CICAT mesh (Dynamesh®).

Detailed Description
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The study will be conducted in the department of surgery in het AZ Maria Middelares, Ghent, Belgium. Dr. Filip Muysoms will personally select and operate all patients eligible for this study. He will inform all patients about the surgery and the follow-up with MRI scan thereafter. Dr. Beckers will perform all MRI examinations of the patients at 1 month and 13 months post-operatively and will be available for questions from the patient. We want to show that with this type of mesh it is possible to visualize the preperitoneal placed mesh in a safe manner. Furthermore, the positioning of the mesh, mesh shrinkage or mesh shifting will be monitored with this technique. This provides long-term benefit and provides early treatment possibilities in case of post-operative complications related to the mesh position.

Official Title
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Prospective Cohort Study on Mesh Shrinkage Measured With MRI After Robot Assisted Laparoscopic Preperitoneal Mesh Repair Using an Iron Oxide Loaded PVDF Mesh

Conditions
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Ventral Hernia, Umbilical Hernia, Ventral Incisional Hernia

Intervention / Treatment
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* Procedure: Hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary umbilical hernias up to 2 cm Incisional hernias limited to zone M3 (EHS classification) and smaller than 2 cm Exclusion Criteria: <18 years Emergency surgery (incarcerated hernia) Clean-contaminated, contaminated or dirty procedures (according to the CDC classification) Lateral hernias Hernias close to the sternum or the pubic bone Hernias bigger than 2 cm in diameter. Hernias that need a component separation technique. Previous mesh repair on the midline ASA score> 4 Pregnancy No patient Informed Consent Life expectancy of less than 2years Contraindications for MRI

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: One single group of 20 patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient<br>Patients scheduled for robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia | Procedure: Hernia repair<br>* Robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of mesh surface (percentage) | Shrinkage rate / change of the mesh surface (percentage) as measured with the MRI between 1 month and 13 months postoperatively, defined as (100 - mesh surface at 13 months x 100 / mesh surface at 1 month) | 1 month and 13 month post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mesh surface between implantation surface size | Change in mesh surface between implantation surface size, surface at 1m and at 13m | 1 month and 13 month post-operatively | 
| Change in mesh width and length between implantation surface size | Change in mesh width and length between implantation surface size, surface at 1m and at 13m | 1 month and 13 month post-operatively | 
| Operation duration | Recording of the operation duration needed for robot-assisted ventral TAPP procedure | once during operation | 
| Intra-operative complications | Intra-operative complications registered until 4 weeks after the hernia repair | until 4 weeks post-operative | 
| Early post-operative complications | Early post-operative complications detected until 30 days after hernia repair | until 30 days post-operative | 
| Late complications | Late complications (after 30 days) | After 30 days post-operative | 
| Quality of Life questionnaire | Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome | Preoperatively, 30 days, 13 months | 
| Body image score | Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome). | Preoperatively, 30 days, 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesh shrinkage, Abdominal wall surgery