Short-term Outcome After Ventral Hernia RepairNCT04115150
Short-term Outcome After Ventral Hernia Repair
An observational study of Short-term Outcome After Ventral Hernia Repair, run by Medical University of Vienna.
Trial summary
Hernia repair in sublay technique is widely accepted for ventral hernias, as it appears to be advantageous in terms of complication and recurrence rates. Recently, self-gripping meshes are increasingly used for hernia repair with retromuscular mesh positioning. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Short-term Outcome After Ventral Hernia Repair
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 1 Sep 2018
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective single-centre cohort study was performed for the time period of January 2011 to July 2018. All patients, receiving a ventral hernia repair (including incisional, umbilical or epigastric hernias) in Rives-Stoppa retromuscular mesh placement technique (sublay), were included into the final analysis.
Who may be able to join
- ventral hernia repair in sublay technique
Who cannot join
- ventral hernia repair in other technique
About this study
Official title: Short-term Outcome After Ventral Hernia Repair Using Self-gripping Mesh in Subway Technique - a Retrospective Cohort Analysis
Hernia repair in sublay technique is widely accepted for ventral hernias, as it appears to be advantageous in terms of complication and recurrence rates. Recently, self-gripping meshes are increasingly used for hernia repair with retromuscular mesh positioning. However, real-life data on the safe use in that specific indication are still lacking. Therefore, this study evaluated short-term postoperative outcome of self-gripping versus conventional non-self-gripping meshes in sublay hernia repair.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| self-gripping mesh | Not described | |
| non-self-gripping mesh | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
overall complication rate, seroma rate, SSI rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Jan 2011
- Primary completion1 Jul 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short-term Outcome After Ventral Hernia RepairStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Harpain, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115150
- Sponsor's protocol ID
- 1258/2018
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcome After Ventral Hernia Repair Using Self-gripping Mesh in Subway Technique - a Retrospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT04115150
- Acronym / sponsor ID
- 1258/2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 3 Oct 2019 (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.
Hernia repair in sublay technique is widely accepted for ventral hernias, as it appears to be advantageous in terms of complication and recurrence rates. Recently, self-gripping meshes are increasingly used for hernia repair with retromuscular mesh positioning. However, real-life data on the safe use in that specific indication are still lacking. Therefore, this study evaluated short-term postoperative outcome of self-gripping versus conventional non-self-gripping meshes in sublay hernia repair.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-gripping mesh | – | – |
| non-self-gripping mesh | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective single-centre cohort study was performed for the time period of January 2011 to July 2018. All patients, receiving a ventral hernia repair (including incisional, umbilical or epigastric hernias) in Rives-Stoppa retromuscular mesh placement technique (sublay), were included into the final analysis.
Key inclusion criteria (1 listed)
- ventral hernia repair in sublay technique
Key exclusion criteria (1 listed)
- ventral hernia repair in other technique
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complication rate
Time frame: 1 year
overall complication rate, seroma rate, SSI rate
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 7 Oct 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Short-term Outcome After Ventral Hernia Repair, run by Medical University of Vienna.
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: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Complication rate (time frame: 1 year). 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 Oct 2019.