NCT02177214

Brief Summary

Purpose of the study is the visualization of the mesh and the determination of the mesh surface observed by MRI at 3 weeks and 13 months after ventral hernia repair with mesh visible IPOM (Dynamesh®). We want to prove that with this type of mesh it is possible to visualize the mesh position in vivo in a safe manner. This provides long-term benefit to early recognize possible recurrence caused by shifting or shrinking of the mesh and to provide early treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

June 26, 2014

Last Update Submit

November 23, 2016

Conditions

HerniaRecurrence

Outcome Measures

Primary Outcomes (1)

  • Visualization

    Clear visualization of the MRI IPOM prosthesis 3 weeks postoperatively

    3 weeks

Secondary Outcomes (1)

  • mesh surface

    13 month

Study Arms (1)

ventral hernia

Adult patients scheduled for elective laparoscopic repair of ventral hernia, with inclusion of primary and incisional hernias. Visualization of the mesh surface observed with MRI scan at 3 weeks and 13 months after ventral hernia repair with a visible IPOM prosthesis (Dynamesh®)

Procedure: MRI scan

Interventions

MRI scanPROCEDURE

Visualization of the mesh surface observed with MRI scan at 3 weeks and 13 months after ventral hernia repair with a visible IPOM prosthesis (Dynamesh®)

ventral hernia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients scheduled for elective laparoscopic repair of ventral hernia, with inclusion of primary and incisional hernias.

You may qualify if:

  • patients scheduled for elective laparoscopic repair of ventral hernia

You may not qualify if:

  • \- \<18 years
  • Lateral hernias (L1-L4), subxyphoidale hernias (M1) or suprapubicale hernias (M5).
  • Emergency surgery (incarcerated hernia)
  • Clean-contaminated or contaminated procedures
  • ASA score\> 4
  • Pregnancy
  • No patient Informed Consent
  • Life expectancy of less than 2years
  • Contra-indications for MRI examination, as of:
  • Implanted electronic devices such as a pacemaker, neuro-stimulator, cochlear implant.
  • Not MRI-compatible valves.
  • Metal foreign bodies (depending on the location relative to the region to investigate).
  • Large tattoos. Note: By default, the patient has to complete a questionnaire before the start of the study. This will be followed with the radiology nurse post-MRI.
  • Claustrophobia, shortness of breath, tremor.
  • In doubt, an internationally accepted list of items will be checked on the website www.mrisafety.com.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Related Publications (2)

  • Muysoms FE, Novik B, Kyle-Leinhase I, Berrevoet F. Mesh fixation alternatives in laparoscopic ventral hernia repair. Surg Technol Int. 2012 Dec;22:125-32.

    PMID: 23225589BACKGROUND

  • Muysoms F, Beckers R, Kyle-Leinhase I. Prospective cohort study on mesh shrinkage measured with MRI after laparoscopic ventral hernia repair with an intraperitoneal iron oxide-loaded PVDF mesh. Surg Endosc. 2018 Jun;32(6):2822-2830. doi: 10.1007/s00464-017-5987-x. Epub 2017 Dec 21.

    PMID: 29270800DERIVED

MeSH Terms

Conditions

HerniaRecurrence

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Filip Muysoms, MD

    Algemeen Ziekenhuis Maria Middelares

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
13 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Abdominal Surgery

Study Record Dates

First Submitted

June 26, 2014

First Posted

June 27, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

November 25, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)