Preperitoneal Umbilical Mesh Area (PUMA)

Algemeen Ziekenhuis Maria Middelares

Status: Enrolling

Conditions: Umbilical Hernia; Ventral Hernia; Ventral Incisional Hernia

Treatments: Procedure: Hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05576753

PUMA

Details and patient eligibility

About

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®).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patient

Experimental group

Description:

Patients scheduled for robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia

Treatment:

Procedure: Hernia repair