Inguinal HerniaNCT02315209
Multicentric Evaluation of UPP, UHS and Ultra Pro Comfort Plug for Inguinal Hernia Surgery Including Quality of Life Evaluation
An observational study of Inguinal Hernia, run by University of Magdeburg.
Trial summary
Outpatient services in Germany are less controlled by external quality assurance programs. Comprehensive outcome data for benchmarking or health-care decision-making are missing e.g. for day case surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- UHS, UPP, Comfort Plug
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2016
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive Patients with inguinal Hernia, Age >18 ys., Mesh Augmentation with Ultra Pro Hernia System, Ultra pro Plug or Ultra pro comfort Plug
Who may be able to join
- Primary and recurrent inguinal Hernia
- Age>18ys
- using 3D devices
Who cannot join
- Age under 18 ys.
About this study
Outpatient services in Germany are less controlled by external quality assurance programs. Comprehensive outcome data for benchmarking or health-care decision-making are missing e.g. for day case surgery. A quality-of-life instrument specific to hernia repair with mesh has been recently proposed (Carolinas Comfort Scale, CCS) .This study evaluates the integration of CSS as part of a multicentre quality assurance scheme for day-case (outpatient) surgery.b.The Study Group on "Quality assurance in ambulatory hernia surgery" has developed and standardized Operation technique for 3D Implants. As a consequence, any deviation must be documented by the standard. The extension to other centers according to a standardized protocol took place (shadowing to learn the operational standards, training in documentation, Minimum quantity 30 interventions per year, etc.).
Read the detailed description
- Rationale
- In the care of inguinal hernias exists a considerable diversity of methods. Germany is expected to experience a significant shift of service delivery from inpatient to outpatient care within the next few years. As a result of this, the need for quality-controlled procedures in the ambulatory use has emerged.
- A first register phase for open inguinal hernia was designed in 2010 and is now almost finished. After the evaluation of approximately 6,000 patient records, the process is considered to be extremely successful.
- As a central result of this first register phase can already be stated that the integration of 3D meshes in a standardized process proved to be extremely effective in open inguinal hernia. In all of the examined relevant parameters, a quality of care well above the status quo could be exhibited.
- This data quality is unique to the hernia care not only in Germany. In Contrast, the results also achieved considerable international attention. Hence, the working group received the Fruchaud prize for presenting the results of the American Hernia Society 2013. (see Annex, www.americanherniasociety.org)
- Objective
- Since this approach has proven successful in the first register phase in every respect, it is now to be continued for another two years in order to develop the basis to establish this concept as widespread (outpatient) standard. The central question will be investigated of whether the outstanding results of register phase 1 will also occur in a wide and distributed application to more centers. If this can be proved, the conditions based on worldwide unique scientific data (methodology and follow-up rates, see below) are created to establish the standard surgical procedure with central integration of 3D meshes (UPP UHS) as gold standard against the Lichtenstein method in the outpatient sector.
- Design
- Prospective multicenter observational study of online-based (daily updated) recording of all relevant pre-, peri-and postoperative data, including patient- as well as physician-specific follow up.
- Analysis of the most relevant patient-specific endpoints recurrence, pain and quality of life with a 4, 12 and 52 weeks follow-up and the use of psychometrically validated Carolina Comfort Scale (anonymous and tamper-resistant).
- Significant expansion of the participating centers with a special comparison of the quality of results between newly added centers and centers, that have been proven already.
- Duration: 01/01/2014 - 12/31/2015 with an additional one-year follow-up to 12/31/2016.
- Conditions
- Inguinal Hernia
- Being tested
- UHS, UPP, Comfort Plug
- Keywords
- Inguinal Hernia, Quality of Life, Mesh
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UHS, UPP, Comfort PlugDevice
only Repairs with 3D Devices (UPP,UHS,Comfort Plug)
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Evaluation with Carolina Comfort Scale
Measured: 4-12-52 weeks after surgery
Secondary outcomes (3)
Postoperative Complications
clinical examination
Measured: 4-12 weeks after surgery
pain after Surgery
clinical examination, questionnaire, VAS
Measured: 4-12-52 weeks after surgery
Recurrence
clinical examination
Measured: 4-12-52 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 posted11 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal 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
- 4,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Andreas Koch MD, FACS, University of Magdeburg
- Investigators
- Andreas Koch, MD, FACS, Principal investigator, Institute for Quality Assurance in Operative MedicineRalph Lorenz, MD, Study chair, Institute for Quality Assurance in Operative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315209
- Sponsor's protocol ID
- GR13-108
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.
PubMed 18387468
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Evaluation of UPP, UHS and Ultra Pro Comfort Plug for Inguinal Hernia Surgery Including Quality of Life Evaluation
- ClinicalTrials.gov ID
- NCT02315209
- Acronym / sponsor ID
- GR13-108
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal Hernia, Quality of Life, Mesh
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Dec 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.
Outpatient services in Germany are less controlled by external quality assurance programs. Comprehensive outcome data for benchmarking or health-care decision-making are missing e.g. for day case surgery. A quality-of-life instrument specific to hernia repair with mesh has been recently proposed (Carolinas Comfort Scale, CCS) .This study evaluates the integration of CSS as part of a multicentre quality assurance scheme for day-case (outpatient) surgery.b.The Study Group on "Quality assurance in ambulatory hernia surgery" has developed and standardized Operation technique for 3D Implants. As a consequence, any deviation must be documented by the standard. The extension to other centers according to a standardized protocol took place (shadowing to learn the operational standards, training in documentation, Minimum quantity 30 interventions per year, etc.).
Detailed description
- Rationale
- In the care of inguinal hernias exists a considerable diversity of methods. Germany is expected to experience a significant shift of service delivery from inpatient to outpatient care within the next few years. As a result of this, the need for quality-controlled procedures in the ambulatory use has emerged.
- A first register phase for open inguinal hernia was designed in 2010 and is now almost finished. After the evaluation of approximately 6,000 patient records, the process is considered to be extremely successful.
- As a central result of this first register phase can already be stated that the integration of 3D meshes in a standardized process proved to be extremely effective in open inguinal hernia. In all of the examined relevant parameters, a quality of care well above the status quo could be exhibited.
- This data quality is unique to the hernia care not only in Germany. In Contrast, the results also achieved considerable international attention. Hence, the working group received the Fruchaud prize for presenting the results of the American Hernia Society 2013. (see Annex, www.americanherniasociety.org)
- Objective
- Since this approach has proven successful in the first register phase in every respect, it is now to be continued for another two years in order to develop the basis to establish this concept as widespread (outpatient) standard. The central question will be investigated of whether the outstanding results of register phase 1 will also occur in a wide and distributed application to more centers. If this can be proved, the conditions based on worldwide unique scientific data (methodology and follow-up rates, see below) are created to establish the standard surgical procedure with central integration of 3D meshes (UPP UHS) as gold standard against the Lichtenstein method in the outpatient sector.
- Design
- Prospective multicenter observational study of online-based (daily updated) recording of all relevant pre-, peri-and postoperative data, including patient- as well as physician-specific follow up.
- Analysis of the most relevant patient-specific endpoints recurrence, pain and quality of life with a 4, 12 and 52 weeks follow-up and the use of psychometrically validated Carolina Comfort Scale (anonymous and tamper-resistant).
- Significant expansion of the participating centers with a special comparison of the quality of results between newly added centers and centers, that have been proven already.
- Duration: 01/01/2014 - 12/31/2015 with an additional one-year follow-up to 12/31/2016.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive Patients with inguinal Hernia, Age >18 ys., Mesh Augmentation with Ultra Pro Hernia System, Ultra pro Plug or Ultra pro comfort Plug
Key inclusion criteria (3 listed)
- Primary and recurrent inguinal Hernia
- Age>18ys
- using 3D devices
Key exclusion criteria (1 listed)
- Age under 18 ys.
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 |
|---|---|---|
| UHS, UPP, Comfort Plugonly Repairs with 3D Devices (UPP,UHS,Comfort Plug) | Device | – |
Primary outcome
Quality of Life
Time frame: 4-12-52 weeks after surgery
Evaluation with Carolina Comfort Scale
3 secondary outcomes
Postoperative Complications
Time frame: 4-12 weeks after surgery
pain after Surgery
Time frame: 4-12-52 weeks after surgery
Recurrence
Time frame: 4-12-52 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
- Background: PubMed 18387468Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.
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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.
Andreas Koch, MD, FACS principal investigator
Institute for Quality Assurance in Operative Medicine
Ralph Lorenz, MD study chair
Institute for Quality Assurance in Operative Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by University of Magdeburg.
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 3 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 11 Dec 2014. 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?
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?
Quality of Life (time frame: 4-12-52 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02315209, which also lists 1 linked publication.
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 2014; AzTrials last refreshed its copy on 8 Nov 2026.