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Completed

NCT Number: NCT03380312

MRI Imaging of Ipsilateral Retromuscular Access

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.

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Key information

Conditions

Hernia, Incisional Hernia Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Maria Middelares

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTARUP technique

Procedure

robot-assisted rTARUP technique

Primary outcomes

  1. Change of the mesh surface (percentage)

    Time frame: 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 outcomes

  1. Change in mesh surface between implantation surface size

    Time frame: 1 month and 13 month post-operatively

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

  2. Change in mesh width and length between implantation surface size

    Time frame: 1 month and 13 month post-operatively

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

  3. Volume of the rectus muscle at the level of the umbilicus

    Time frame: 1 month and 13 month post-operatively

    Volume of the rectus muscle at the level of the umbilicus on both sides at 1m and at 13m

  4. Operation duration

    Time frame: once during operation

    recording of the operation duration needed for robo-assisted TARUP

  5. Intra-operative complications

    Time frame: until 4 weeks post-operative

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

  6. Early post-operative complications

    Time frame: until 30 days post-operative

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

  7. Late complications

    Time frame: after 30 days post-operative

    Late complications (after 30 days)

  8. Quality of Life questionnaire

    Time frame: preoperative and 1 month and 13 month post-operatively

    A questionnaire will be used to measured life quality of the participants preoperatively and at 1m and 13m postoperatively

Sponsors and collaborators

Lead sponsor

Filip Muysoms

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Dec 21, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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