MRI Imaging of Ipsilateral Retromuscular Access

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-26

Study Completion Date

2022-01-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preperitoneal Umbilical Mesh Area

NCT05576753

Ventral Hernia Umbilical Hernia Ventral Incisional Hernia

UNKNOWN NA

MRI Imaging of Retromuscular Hernia Repair With CICAT Visible®

NCT02460029

Hernia Recurrence

UNKNOWN

Magnetic Resonance Imaging of Mesh Position After Ventral Hernia Repair

NCT02177214

Hernia Recurrence

COMPLETED

Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair

NCT03904888

Inguinal Hernia

RECRUITING NA

Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias

NCT01639118

Ventral Hernia Umbilical Hernia Epigastric Hernia

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hernia, Incisional

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rTARUP technique

robot-assisted rTARUP technique

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No