Clinical trial NCT03380312: MRI Imaging of Ipsilateral Retromuscular Access
Official title: Prospective Cohort Study on Mesh Shrinkage Measured with MRI After Robot Assisted Laparoscopic Retromuscular Hernia Repair Using an Iron Oxide Loaded PVDF Mesh
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Incisional
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients scheduled for robot assisted laparoscopic retromuscular repair (rTARUP =robotic Trans Abdominal Retromuscular Umbilical Prosthesis) of a midline ventral hernia will be invited to take part in the study. Both primary ventral and incisional midline hernias will be included (EHS classification M1-M5).

A total of 20 patients will be enrolled in this observational study.

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 retromuscular incisional hernia repair with ipsilateral access and the use of the visible CICAT mesh (Dynamesh®) for defect repair. The investigators also want to measure the volume of the rectus muscles and the change between 1 and 13 months.

Detailed description: 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 retromuscular incisional hernia repair with ipsilateral access and the use of the visible CICAT mesh (Dynamesh®) for defect repair. The investigators also want to measure the volume of the rectus muscles and the change between 1 and 13 months. Possibly the ipsilateral retromuscular access could induce some atrophy of the rectus muscles.

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. Dr.Muysoms will inform all patients about the surgery and the follow-up with MRI scan thereafter. Dr. Beckers and Dr. Heindryckx 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.

The investigators want to show that with this type of mesh it is possible to visualize the mesh after retromusculare placement in vivo 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:

* 20 patients selected and operated by PI.

Exclusion Criteria:

* \<18 years
* Emergency surgery (incarcerated hernia)
* Clean-contaminated, contaminated or dirty procedures (according to the CDC classification)
* Lateral hernias
* 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 the 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: Volume of the rectus muscle at the level of the umbilicus
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: preoperative and 1 month and 13 month post-operatively
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
Study officials:
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Filip Muysoms, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: