MRI Imaging of Ipsilateral Retromuscular Access

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 retromuscular incisional hernia repair with ipsilateral access and the use of the visible CICAT mesh (Dynamesh®) for defect repair. The investigators also want to measure the volume of the rectus muscles and the change between 1 and 13 months.

Detailed Description
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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 retromuscular incisional hernia repair with ipsilateral access and the use of the visible CICAT mesh (Dynamesh®) for defect repair. The investigators also want to measure the volume of the rectus muscles and the change between 1 and 13 months. Possibly the ipsilateral retromuscular access could induce some atrophy of the rectus muscles. 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. Dr.Muysoms will inform all patients about the surgery and the follow-up with MRI scan thereafter. Dr. Beckers and Dr. Heindryckx 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. The investigators want to show that with this type of mesh it is possible to visualize the mesh after retromusculare placement in vivo 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 Retromuscular Hernia Repair Using an Iron Oxide Loaded PVDF Mesh

Conditions
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Hernia, Incisional

Intervention / Treatment
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* Procedure: rTARUP technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 patients selected and operated by PI. Exclusion Criteria: <18 years Emergency surgery (incarcerated hernia) Clean-contaminated, contaminated or dirty procedures (according to the CDC classification) Lateral hernias 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: rTARUP technique|robot-assisted rTARUP technique|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the 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 | 
| Volume of the rectus muscle at the level of the umbilicus | Volume of the rectus muscle at the level of the umbilicus on both sides at 1m and at 13m | 1 month and 13 month post-operatively | 
| Operation duration | recording of the operation duration needed for robo-assisted TARUP | 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 | A questionnaire will be used to measured life quality of the participants preoperatively and at 1m and 13m postoperatively | preoperative and 1 month and 13 month post-operatively |