NCT03380312

MRI Imaging of Ipsilateral Retromuscular Access

Prospective Cohort Study on Mesh Shrinkage Measured with MRI After Robot Assisted Laparoscopic Retromuscular Hernia Repair Using an Iron Oxide Loaded PVDF Mesh

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Filip Muysoms · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Hernia, Incisional

Interventions

Type	Name	Description
PROCEDURE	rTARUP technique	robot-assisted rTARUP technique

Timeline

• Start date: 2017-09-26
• Primary completion: 2021-06-19
• Completion: 2022-01-19
• First posted: 2017-12-21
• Last updated: 2024-09-19

Locations

1 site across 1 country: Belgium