Ventral HerniaRe-SITUPNCT01761708
Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch
An observational study of Ventral Hernia and Umbilical Hernia, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial summary
Ventral hernias, such as umbilical, epigastric and trocar-site hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia, Umbilical Hernia, Epigastric Hernia
- What is being tested?
- primary ventral hernia repair with mesh
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Aug 2013
- How long will I take part?
- 12 Months
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- all adult patients that are planned for surgical repair of a umbilical, epigastric or trocar-site hernia will be considered to enter the study.
Who cannot join
- patients refusing to participate at the follow up visits pregnancy age < 18 years life expectancy less than 12 months emergency operations liver cirrhosis or ascites cancer patients concomitant surgery other than hernia repair
Trial locations and contacts
1 site in 1 country.
About this study
Ventral hernias, such as umbilical, epigastric and trocar-site hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect. The SITUP-trial was a prospective cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects. The study was stopped prematurely because of the perception of an unacceptably high rate of mesh infection. This new study will retrospectively examine the incidence of mesh infection in all ventral hernias repaired with a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.
- Being tested
- primary ventral hernia repair with mesh
- Keywords
- primary ventral hernia repair with mesh, umbilical hernia repair, epigastric hernia repair, C-Qur V-patch, Size tailored repair, preperitoneal repair, abdominal hernia, dual sided mesh, trocar-site hernia
- Medical subject headings
- Hernia, Ventral, Hernia, Umbilical, Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary ventral hernia repair with meshProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| umbilical, epigastric and trocar-site hernia | Not described Receives: Procedure: primary ventral hernia repair with mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
mesh infection
Measured: incidence over 12 months
Secondary outcomes (1)
hernia recurrence rate
Measured: incidence over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stijn De Sutter, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Stijn De Sutter, MD, Principal investigator, Algemeen Ziekenhuis Maria MiddelaresFilip Muysoms, MD, Study director, Algemeen Ziekenhuis Maria MiddelaresIris Kyle-Leinhase, PhD, Study chair, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761708
- Sponsor's protocol ID
- Re-situp
- Acronym
- Re-SITUP
- Status last verified
- Jan 2013
- First submitted
- 3 Jan 2013
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch
- ClinicalTrials.gov ID
- NCT01761708
- Acronym / sponsor ID
- Re-SITUP / Re-situp
- Keywords
- primary ventral hernia repair with mesh, umbilical hernia repair, epigastric hernia repair, C-Qur V-patch, Size tailored repair, preperitoneal repair, abdominal hernia, dual sided mesh
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- 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.
Ventral hernias, such as umbilical, epigastric and trocar-site hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect. The SITUP-trial was a prospective cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects. The study was stopped prematurely because of the perception of an unacceptably high rate of mesh infection. This new study will retrospectively examine the incidence of mesh infection in all ventral hernias repaired with a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| umbilical, epigastric and trocar-site hernia | – | Procedure: primary ventral hernia repair with mesh |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- all adult patients that are planned for surgical repair of a umbilical, epigastric or trocar-site hernia will be considered to enter the study.
Key exclusion criteria (1 listed)
- patients refusing to participate at the follow up visits pregnancy age < 18 years life expectancy less than 12 months emergency operations liver cirrhosis or ascites cancer patients concomitant surgery other than hernia repair
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 |
|---|---|---|
| primary ventral hernia repair with mesh | Procedure or surgery | umbilical, epigastric and trocar-site hernia |
Primary outcome
mesh infection
Time frame: incidence over 12 months
1 secondary outcome
hernia recurrence rate
Time frame: incidence over 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
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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.
Stijn De Sutter, MD principal investigator
Algemeen Ziekenhuis Maria Middelares
Filip Muysoms, MD study director
Algemeen Ziekenhuis Maria Middelares
Iris Kyle-Leinhase, PhD study chair
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 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 1 inclusion and 1 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 7 Jan 2013. 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?
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?
mesh infection (time frame: incidence over 12 months). 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 7 Jan 2013.