Hernia Recurrence Post Laparoscopic Incisional Hernia Repair in Liver Transplant Versus Non-transplant Patients.NCT02123719
Laparoscopic Incisional Hernia Repair in Liver Transplant Patients
An observational study of Hernia Recurrence Post Laparoscopic Incisional Hernia Repair in Liver Transplant Versus Non-transplant Patients., run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Retrospective analysis of patients undergoing laparoscopic incisional hernia repair. Study group: Patients with incisional hernia post liver transplantation Control group: Patients with incisional hernia post any other laparotomy in the upper quadrant. Primary study outcome parameter: Risk of hernia recurrence. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia Recurrence Post Laparoscopic Incisional Hernia Repair in Liver Transplant Versus Non-transplant Patients.
- What is being tested?
- Surgery
- How many people
- 112 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2013to Feb 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient with incisional hernia post liver transplantation
Who may be able to join
- Incisional hernia
- Laparoscopic repair possible
Who cannot join
- Other types of ventral hernias
- Laparoscopy not possible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes Analysis of Laparoscopic Incisional Hernia Repair and Risk Factors for Hernia Recurrence in Liver Transplant Patients
Retrospective analysis of patients undergoing laparoscopic incisional hernia repair.
Study group: Patients with incisional hernia post liver transplantation Control group: Patients with incisional hernia post any other laparotomy in the upper quadrant.
Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome parameters: - Hernia repair-related infection rate
- Postoperative morbidity Statistical analysis: Comparison of study versus control group, univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values <0.05 were considered significant.
- Being tested
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
| Study group | Role | What they receive |
|---|---|---|
| Patients post liver transplantation | Patients after liver transplantation Receives: Other: Surgery | |
| Control group | Patients with an abdominal incisional hernia without a history of immunosuppresion Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence post laparoscopic incisional hernia repair
Measured: 1 - 74 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia Recurrence Post Laparoscopic Incisional Hernia Repair in Liver Transplant Versus Non-transplant Patients.Studies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Biebl, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123719
- Sponsor's protocol ID
- 1304197302
- Status last verified
- Apr 2014
- First submitted
- 24 Apr 2014
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Analysis of Laparoscopic Incisional Hernia Repair and Risk Factors for Hernia Recurrence in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT02123719
- Acronym / sponsor ID
- 1304197302
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Apr 2014 (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.
Retrospective analysis of patients undergoing laparoscopic incisional hernia repair.
Study group: Patients with incisional hernia post liver transplantation Control group: Patients with incisional hernia post any other laparotomy in the upper quadrant.
Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome parameters: - Hernia repair-related infection rate
- Postoperative morbidity Statistical analysis: Comparison of study versus control group, univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values <0.05 were considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients post liver transplantation | – | Other: SurgeryPatients after liver transplantation |
| Control group | – | Other: SurgeryPatients with an abdominal incisional hernia without a history of immunosuppresion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with incisional hernia post liver transplantation
Key inclusion criteria (2 listed)
- Incisional hernia
- Laparoscopic repair possible
Key exclusion criteria (2 listed)
- Other types of ventral hernias
- Laparoscopy not possible
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 |
|---|---|---|
| Surgery | Other | Control group, Patients post liver transplantation |
Primary outcome
Hernia recurrence post laparoscopic incisional hernia repair
Time frame: 1 - 74 months post surgery
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 25 Apr 2014.
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.
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 Hernia Recurrence Post Laparoscopic Incisional Hernia Repair in Liver Transplant Versus Non-transplant Patients., run by Medical University Innsbruck 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 25 Apr 2014. 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?
Hernia recurrence post laparoscopic incisional hernia repair (time frame: 1 - 74 months post 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 25 Apr 2014.