MRI Imaging of Ipsilateral Retromuscular Access

Prospective Cohort Study on Mesh Shrinkage Measured With MRI After Robot Assisted Laparoscopic Retromuscular Hernia Repair Using an Iron Oxide Loaded PVDF Mesh

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.

Study Overview

• Status: Unknown
• Conditions: Hernia, Incisional
• Intervention / Treatment: Procedure: rTARUP technique

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • AZ Maria Middelares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the 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)	1 month and 13 month post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mesh surface between implantation surface size	Change in mesh surface between implantation surface size, surface at 1m and at 13m	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	1 month and 13 month post-operatively
Intra-operative complications	Intra-operative complications registered until 4 weeks after the hernia repair	until 4 weeks post-operative
Early post-operative complications	Early post-operative complications detected until 30 days after hernia repair	until 30 days post-operative
Volume of the rectus muscle at the level of the umbilicus	Volume of the rectus muscle at the level of the umbilicus on both sides at 1m and at 13m	1 month and 13 month post-operatively
Operation duration	recording of the operation duration needed for robo-assisted TARUP	once during operation
Late complications	Late complications (after 30 days)	after 30 days post-operative
Quality of Life questionnaire	A questionnaire will be used to measured life quality of the participants preoperatively and at 1m and 13m postoperatively	preoperative and 1 month and 13 month post-operatively

Collaborators and Investigators

• Sponsor: Filip Muysoms
• Investigators: Principal Investigator: Filip Muysoms, MD,PhD, Algemeen ziekenhuis Maria Middelares

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: IRMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No