Preperitoneal Umbilical Mesh Area

Algemeen Ziekenhuis Maria Middelares20 enrolled

Overview

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®).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ventral Hernia Umbilical Hernia Ventral Incisional Hernia

Interventions

Hernia repairPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

AZ Maria Middelares

Ghent, Belgium

RECRUITING

Outcomes

Primary Outcomes

Change of 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)

Time frame: 1 month and 13 month post-operatively

Secondary Outcomes

Change in mesh surface between implantation surface size

Change in mesh surface between implantation surface size, surface at 1m and at 13m

Time frame: 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

Time frame: 1 month and 13 month post-operatively

Operation duration

Recording of the operation duration needed for robot-assisted ventral TAPP procedure

Time frame: once during operation

Intra-operative complications

Intra-operative complications registered until 4 weeks after the hernia repair

Time frame: until 4 weeks post-operative

Early post-operative complications

Early post-operative complications detected until 30 days after hernia repair

Time frame: until 30 days post-operative

Late complications

Late complications (after 30 days)

Time frame: After 30 days post-operative

Central Contacts

Maaike Vierstraete, MD

CONTACT

003292467400 maaikevierstraete@icloud.com

Filip Muysoms, MD

CONTACT

003282467400 filip.muysoms@azmmsj.be

Data from ClinicalTrials.gov

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