MRI Imaging of Ipsilateral Retromuscular Access

NCT03380312 | Completed

• 1 other identifier: IRMA
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Incisional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in mesh surface between implantation surface size

  1 month and 13 month post-operatively

• Change in mesh width and length between implantation surface size

  1 month and 13 month post-operatively

• Volume of the rectus muscle at the level of the umbilicus

  1 month and 13 month post-operatively

• Operation duration

  once during operation

• Intra-operative complications

  until 4 weeks post-operative

Interventions

rTARUP technique PROCEDURE

robot-assisted rTARUP technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients selected and operated by PI.

You may not qualify if:

• \<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

Sponsors & Collaborators

• Filip Muysoms: lead

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Related Publications (1)

• Vierstraete M, Beckers R, Vangeel L, Foriers B, Pletinckx P, Muysoms F. Prospective cohort study on mesh shrinkage measured with MRI after robot-assisted minimal invasive retrorectus ventral hernia repair using an iron-oxide-loaded polyvinylidene fluoride mesh. Surg Endosc. 2023 Jun;37(6):4604-4612. doi: 10.1007/s00464-023-09938-3. Epub 2023 Feb 28.

  PMID: 36854798 DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

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

Study Officials

• Filip Muysoms, MD,PhD

  Algemeen Ziekenhuis Maria Middelares

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgeon

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 21, 2017
• Study Start: September 26, 2017
• Primary Completion: June 19, 2021
• Study Completion: January 19, 2022
• Last Updated: September 19, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)