Ventral HerniaPUMANCT05576753
Preperitoneal Umbilical Mesh Area
A study testing Hernia repair in people with Ventral Hernia and Umbilical Hernia, run by Algemeen Ziekenhuis Maria Middelares 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 preperitoneal hernia repair using the visible CICAT mesh (Dynamesh®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Umbilical Hernia, Ventral Incisional Hernia
- What is being tested?
- Hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2023to 1 Apr 2025
- Phase
- Interventional
- 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
Who may be able to join
- Primary umbilical hernias up to 2 cm
- Incisional hernias limited to zone M3 (EHS classification) and smaller than 2 cm
Who cannot join
- <18 years
- Emergency surgery (incarcerated hernia)
- Clean-contaminated, contaminated or dirty procedures (according to the CDC classification)
- Lateral hernias
- Hernias close to the sternum or the pubic bone
- Hernias bigger than 2 cm in diameter.
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- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
AZ Maria Middelares
Ghent, 9000
Maaike Vierstraete, MD
About this study
Official title: Prospective Cohort Study on Mesh Shrinkage Measured With MRI After Robot Assisted Laparoscopic Preperitoneal Mesh 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 preperitoneal hernia repair using the visible CICAT mesh (Dynamesh®).
Read the detailed description
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. He will inform all patients about the surgery and the follow-up with MRI scan thereafter. Dr. Beckers 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.
We want to show that with this type of mesh it is possible to visualize the preperitoneal placed mesh 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
- Ventral Hernia, Umbilical Hernia, Ventral Incisional Hernia
- Being tested
- Hernia repair
- Keywords
- Mesh shrinkage, Abdominal wall surgery
- Medical subject headings
- Hernia, Ventral, Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hernia repairProcedure or surgery
Robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Patients scheduled for robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia Receives: Procedure: Hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 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
Operation duration
Recording of the operation duration needed for robot-assisted ventral TAPP procedure
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
Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome
Measured: Preoperatively, 30 days, 13 months
Body image score
Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome).
Measured: Preoperatively, 30 days, 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Feb 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One single group of 20 patients
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maaike Vierstraete, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Maaike Vierstraete, Principal investigator, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576753
- Sponsor's protocol ID
- PUMA
- Acronym
- PUMA
- Status last verified
- Mar 2023
- First submitted
- 25 Sep 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. 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 Preperitoneal Mesh Repair Using an Iron Oxide Loaded PVDF Mesh
- ClinicalTrials.gov ID
- NCT05576753
- Acronym / sponsor ID
- PUMA / PUMA
- Conditions
- Ventral Hernia, Umbilical Hernia, Ventral Incisional Hernia
- Keywords
- Mesh shrinkage, Abdominal wall surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 12 Oct 2022 (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 preperitoneal hernia repair using the visible CICAT mesh (Dynamesh®).
Detailed description
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. He will inform all patients about the surgery and the follow-up with MRI scan thereafter. Dr. Beckers 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.
We want to show that with this type of mesh it is possible to visualize the preperitoneal placed mesh 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One single group of 20 patients
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Procedure: Hernia repairPatients scheduled for robot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary umbilical hernias up to 2 cm
- Incisional hernias limited to zone M3 (EHS classification) and smaller than 2 cm
Key exclusion criteria (13 listed)
- <18 years
- Emergency surgery (incarcerated hernia)
- Clean-contaminated, contaminated or dirty procedures (according to the CDC classification)
- Lateral hernias
- Hernias close to the sternum or the pubic bone
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 |
|---|---|---|
| Hernia repairRobot assisted laparoscopic preperitoneal repair (vTAPP: ventral transabdominal preperitoneal hernia repair) of a midline ventral hernia | Procedure or surgery | Patient |
Primary outcome
Change of 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
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: Preoperatively, 30 days, 13 months
Body image score
Time frame: Preoperatively, 30 days, 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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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.
Maaike Vierstraete 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?
A study testing Hernia repair in people with Ventral Hernia and Umbilical Hernia, run by Algemeen Ziekenhuis Maria Middelares 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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 22 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maaike Vierstraete, MD (003292467400, maaikevierstraete@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 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?
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 22 Mar 2023.