Groin HerniaNCT05952791
Case Report in Complications After Laparoscopic Transabdominal Preperitoneal Groin Hernia Repair Using LiquiBandFIX8®
An observational study of Groin Hernia, run by Kepler University Hospital at 1 site in Austria.
Trial summary
This an a case report about management and proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Groin Hernia
- What is being tested?
- Surgery
- How many people
- 1 participants
- Where
- 1 siteAustria
- Study dates
- 5 Jan 2022to 5 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Retrospective case report of one patient
Who may be able to join
- Retrospective case report of one patient undergoing laparoscopic groin hernia repair
Who cannot join
- not applicable (retrospective)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Transabdominal Preperitoneal (TAPP) Groin Hernia Repair Using N-butyl-2-cyanoacrylate (LiquiBandFIX8®)for Mesh Fixation and Peritoneal Closure: Case Report About Extraperitoneal Hematoma
This an a case report about management and proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair. The patient had anticoagulation due to a mechanical valvula and postoperatively the patient developed a huge hematoma extraperitoneally. Relaparoscopy war performed to identify the problem and check the peritoneal closure.
Read the detailed description
This an a case report for proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair (TAPP). The patient had anticoagulation due to a mechanical valvula and postoperatively after TAPP the patient developed a huge hematoma extraperitoneally. The investigatorsperformed relaparoscopy for diagnostic and therapeutic reasons to check stop the bleeding and control the integrety of the peritoneal closure.
- Conditions
- Groin Hernia
- Being tested
- Surgery
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Laparoscopic transabdominal preperitoneal (TAPP) groin hernia repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Strongness of LiquiBandFIX8®
Mesh dislocation, mesh damage (yes/no)
Measured: 2 weeks
Hemtoma
intraperitoneal blood (yes/no)
Measured: 2 weeks
Strongness of LiquiBandFIX8®
peritoneal leakage, peritoneal damage (yes/no)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start5 Jan 2022
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Groin 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Raab, MD, Principal investigator, Kepler University Hospital Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952791
- Sponsor's protocol ID
- KeplerUH
- Status last verified
- Jul 2023
- First submitted
- 7 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Transabdominal Preperitoneal (TAPP) Groin Hernia Repair Using N-butyl-2-cyanoacrylate (LiquiBandFIX8®)for Mesh Fixation and Peritoneal Closure: Case Report About Extraperitoneal Hematoma
- ClinicalTrials.gov ID
- NCT05952791
- Acronym / sponsor ID
- KeplerUH
- Conditions
- Groin Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 19 Jul 2023 (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.
This an a case report about management and proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair. The patient had anticoagulation due to a mechanical valvula and postoperatively the patient developed a huge hematoma extraperitoneally. Relaparoscopy war performed to identify the problem and check the peritoneal closure.
Detailed description
This an a case report for proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair (TAPP). The patient had anticoagulation due to a mechanical valvula and postoperatively after TAPP the patient developed a huge hematoma extraperitoneally. The investigatorsperformed relaparoscopy for diagnostic and therapeutic reasons to check stop the bleeding and control the integrety of the peritoneal closure.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective case report of one patient
Key inclusion criteria (1 listed)
- Retrospective case report of one patient undergoing laparoscopic groin hernia repair
Key exclusion criteria (1 listed)
- not applicable (retrospective)
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 |
|---|---|---|
| SurgeryLaparoscopic transabdominal preperitoneal (TAPP) groin hernia repair | Other | – |
Primary outcome
Strongness of LiquiBandFIX8®
Time frame: 2 weeks
Mesh dislocation, mesh damage (yes/no)
Hemtoma
Time frame: 2 weeks
intraperitoneal blood (yes/no)
Strongness of LiquiBandFIX8®
Time frame: 2 weeks
peritoneal leakage, peritoneal damage (yes/no)
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 Jul 2023.
- Individual participant dataSharing planned: No
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Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
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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.
Sandra Raab, MD principal investigator
Kepler University Hospital Linz
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 Groin Hernia, run by Kepler University Hospital 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 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 19 Jul 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 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?
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?
Strongness of LiquiBandFIX8® (time frame: 2 weeks). The study lists 3 primary outcomes in all. 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 19 Jul 2023.