Ventral Hernia, Umbilical Hernia, Ventral Incisional Hernia
Conditions
Keywords
Mesh shrinkage, Abdominal wall surgery
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.
Interventions
PROCEDUREHernia repair
Robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia
Sponsors
Algemeen Ziekenhuis Maria Middelares
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One single group of 20 patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of mesh surface (percentage) | 1 month and 13 month post-operatively | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mesh width and length between implantation surface size | 1 month and 13 month post-operatively | Change in mesh width and length between implantation surface size, surface at 1m and at 13m |
| Operation duration | once during operation | Recording of the operation duration needed for robot-assisted ventral TAPP procedure |
| Intra-operative complications | until 4 weeks post-operative | Intra-operative complications registered until 4 weeks after the hernia repair |
| Change in mesh surface between implantation surface size | 1 month and 13 month post-operatively | Change in mesh surface between implantation surface size, surface at 1m and at 13m |
| Late complications | After 30 days post-operative | Late complications (after 30 days) |
| Quality of Life questionnaire | Preoperatively, 30 days, 13 months | Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome |
| Body image score | Preoperatively, 30 days, 13 months | Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome). |
| Early post-operative complications | until 30 days post-operative | Early post-operative complications detected until 30 days after hernia repair |
Countries
Belgium
Contacts
Primary ContactMaaike Vierstraete, MD
Backup ContactFilip Muysoms, MD
Outcome results
None listed