Hernia, InguinalNCT02457728
Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate
A study testing LiquiBandFix8 in people with Hernia, Inguinal, run by St John of God Hospital, Vienna at 1 site in Austria.
Trial summary
Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- LiquiBandFix8
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inguinal hernia,
- femoral hernia
Who cannot join
- pregnancy,
- not able to understand patient information
Trial locations and contacts
1 site in 1 country.
About this study
Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.
Read the detailed description
During transabdominal pre peritoneal (TAPP) hernia repair a mesh should be fixed at four pre-determined points. Number of attempts to fix the mesh with a novel non-penetrating fixation device (LiquiBandFix8) will be recorded. This novel device uses n-butyl cyanoacrylate and a defined amount of glue can be delivered with this 5mm laparoscopic instrument (liquid anchors).
In addition, closure of peritoneum should be accomplished using this device.
- Conditions
- Hernia, Inguinal
- Being tested
- LiquiBandFix8
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquiBandFix8Device
Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
| Study group | Role | What they receive |
|---|---|---|
| Inguinal herniation | Experimental | In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient. Receives: Device: LiquiBandFix8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively.
Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction.
Measured: During hospitalization and 6 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hernia, InguinalStudies 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
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- St John of God Hospital, Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard Dauser, MD, St John of God Hospital, Vienna
- Investigators
- Bernhard DAUSER, MD, Principal investigator, St John of God Hospital, Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457728
- Sponsor's protocol ID
- StJohn
- Status last verified
- Oct 2015
- First submitted
- 17 May 2015
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate
- ClinicalTrials.gov ID
- NCT02457728
- Acronym / sponsor ID
- StJohn
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- St John of God Hospital, ViennaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Posted 11 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.
Detailed description
During transabdominal pre peritoneal (TAPP) hernia repair a mesh should be fixed at four pre-determined points. Number of attempts to fix the mesh with a novel non-penetrating fixation device (LiquiBandFix8) will be recorded. This novel device uses n-butyl cyanoacrylate and a defined amount of glue can be delivered with this 5mm laparoscopic instrument (liquid anchors).
In addition, closure of peritoneum should be accomplished using this device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inguinal herniation | Experimental | Device: LiquiBandFix8In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inguinal hernia,
- femoral hernia
Key exclusion criteria (2 listed)
- pregnancy,
- not able to understand patient information
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 |
|---|---|---|
| LiquiBandFix8Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair. | Device | Inguinal herniation |
Primary outcome
Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively.
Time frame: During hospitalization and 6 weeks after surgery.
Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bernhard DAUSER, MD principal investigator
St John of God Hospital, Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiquiBandFix8 in people with Hernia, Inguinal, run by St John of God Hospital, Vienna at 1 site in Austria.
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 2 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 11 Dec 2015. 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 Austria. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively. (time frame: During hospitalization and 6 weeks after surgery.). 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 11 Dec 2015.