Hernia, IncisionalNCT03380312
MRI Imaging of Ipsilateral Retromuscular Access
An observational study of Hernia, Incisional, run by Filip Muysoms at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Incisional
- What is being tested?
- rTARUP technique
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Sep 2017to 19 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 20 patients selected and operated by PI.
Who cannot join
- <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
Show all 11Show fewer
- ASA score> 4
- Pregnancy
- No patient Informed Consent
- Life expectancy of less than 2years
- Contraindications for MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hernia, Incisional
- Being tested
- rTARUP technique
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTARUP techniqueProcedure or surgery
robot-assisted rTARUP technique
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month and 13 month post-operatively
Secondary outcomes (8)
Change in mesh surface between implantation surface size
Change in mesh surface between implantation surface size, surface at 1m and at 13m
Measured: 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
Measured: 1 month and 13 month post-operatively
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
Measured: 1 month and 13 month post-operatively
Operation duration
recording of the operation duration needed for robo-assisted TARUP
Measured: once during operation
Intra-operative complications
Intra-operative complications registered until 4 weeks after the hernia repair
Measured: until 4 weeks post-operative
Early post-operative complications
Early post-operative complications detected until 30 days after hernia repair
Measured: until 30 days post-operative
Late complications
Late complications (after 30 days)
Measured: 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
Measured: preoperative and 1 month and 13 month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start26 Sep 2017
- Primary completion19 Jun 2021
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, IncisionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Filip Muysoms
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Filip Muysoms, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Filip Muysoms, MD,PhD, Principal investigator, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380312
- Sponsor's protocol ID
- IRMA
- Status last verified
- Mar 2023
- First submitted
- 6 Dec 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36854798
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Mesh Shrinkage Measured with MRI After Robot Assisted Laparoscopic Retromuscular Hernia Repair Using an Iron Oxide Loaded PVDF Mesh
- ClinicalTrials.gov ID
- NCT03380312
- Acronym / sponsor ID
- IRMA
- Conditions
- Hernia, Incisional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Filip MuysomsUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 19 Jun 2021 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 20 patients selected and operated by PI.
Key exclusion criteria (11 listed)
- <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTARUP techniquerobot-assisted rTARUP technique | Procedure or surgery | – |
Primary outcome
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)
8 secondary outcomes
Change in mesh surface between implantation surface size
Time frame: 1 month and 13 month post-operatively
Change in mesh width and length between implantation surface size
Time frame: 1 month and 13 month post-operatively
Volume of the rectus muscle at the level of the umbilicus
Time frame: 1 month and 13 month post-operatively
Operation duration
Time frame: once during operation
Intra-operative complications
Time frame: until 4 weeks post-operative
Early post-operative complications
Time frame: until 30 days post-operative
Late complications
Time frame: after 30 days post-operative
Quality of Life questionnaire
Time frame: preoperative and 1 month and 13 month post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 36854798Vierstraete 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.
- Individual participant dataSharing planned: No
Related trials for Hernia, Incisional
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingObservational study
Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
Incisional Hernia
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Muysoms, MD,PhD principal investigator
Algemeen Ziekenhuis Maria Middelares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Incisional, run by Filip Muysoms at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the mesh surface (percentage) (time frame: 1 month and 13 month post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03380312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.