Clinical trial NCT05576753: Preperitoneal Umbilical Mesh Area
Official title: Prospective Cohort Study on Mesh Shrinkage Measured With MRI After Robot Assisted Laparoscopic Preperitoneal Mesh Repair Using an Iron Oxide Loaded PVDF Mesh
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventral Hernia
Umbilical Hernia
Ventral Incisional Hernia
Keywords: Mesh shrinkage
Abdominal wall surgery
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One single group of 20 patients
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of mesh surface (percentage)
timeFrame: 1 month and 13 month post-operatively
Secondary outcomes:
measure: Change in mesh surface between implantation surface size
timeFrame: 1 month and 13 month post-operatively
measure: Change in mesh width and length between implantation surface size
timeFrame: 1 month and 13 month post-operatively
measure: Operation duration
timeFrame: once during operation
measure: Intra-operative complications
timeFrame: until 4 weeks post-operative
measure: Early post-operative complications
timeFrame: until 30 days post-operative
measure: Late complications
timeFrame: After 30 days post-operative
measure: Quality of Life questionnaire
timeFrame: Preoperatively, 30 days, 13 months
measure: Body image score
timeFrame: Preoperatively, 30 days, 13 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
Study officials:
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Maaike Vierstraete
role: PRINCIPAL_INVESTIGATOR
References: