Preperitoneal Umbilical Mesh Area

NCT ID: NCT05576753

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-04-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient

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

Group Type: EXPERIMENTAL

Hernia repair

Intervention Type: PROCEDURE

Robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia

Interventions

Hernia repair

Robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Algemeen Ziekenhuis Maria Middelares

OTHER

Sponsor Role: lead

Responsible Party

Maaike Vierstraete

Medical Doctor Department General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maaike Vierstraete

Role: PRINCIPAL_INVESTIGATOR

Algemeen Ziekenhuis Maria Middelares

Locations

AZ Maria Middelares

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Maaike Vierstraete, MD

Role: CONTACT

maaikevierstraete@icloud.com

003292467400

Filip Muysoms, MD

Role: CONTACT

filip.muysoms@azmmsj.be

003282467400

Facility Contacts

Maaike Vierstraete, MD

Role: primary

Other Identifiers

PUMA

Identifier Type: -

Identifier Source: org_study_id