NCT05576753

Preperitoneal Umbilical Mesh Area

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Algemeen Ziekenhuis Maria Middelares · 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 preperitoneal hernia repair using the visible CICAT mesh (Dynamesh®).

Detailed description

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.

Conditions

• Ventral Hernia
• Umbilical Hernia
• Ventral Incisional Hernia

Interventions

Type	Name	Description
PROCEDURE	Hernia repair	Robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-12-31
• Completion: 2025-04-01
• First posted: 2022-10-12
• Last updated: 2023-03-22

Locations

1 site across 1 country: Belgium