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Multicentric Evaluation of UPP, UHS and Ultra Pro Comfort Plug for Inguinal Hernia Surgery Including Quality of Life Evaluation

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ClinicalTrials.gov Identifier: NCT02315209
Recruitment Status : Unknown
Verified December 2014 by Dr.Andreas Koch MD, FACS, University of Magdeburg.
Recruitment status was:  Enrolling by invitation
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Dr.Andreas Koch MD, FACS, University of Magdeburg

Brief 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. 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.).

Condition or disease Intervention/treatment
Inguinal Hernia Device: UHS, UPP, Comfort Plug

Detailed Description:
  • Rationale

    1. 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.
    2. 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.
    3. 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.
    4. 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

    a. 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

    1. 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.
    2. 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).
    3. 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.
    4. Duration: 01/01/2014 - 12/31/2015 with an additional one-year follow-up to 12/31/2016.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia


Intervention Details:
  • Device: UHS, UPP, Comfort Plug
    only Repairs with 3D Devices (UPP,UHS,Comfort Plug)


Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 4-12-52 weeks after surgery ]
    Evaluation with Carolina Comfort Scale


Secondary Outcome Measures :
  1. Postoperative Complications [ Time Frame: 4-12 weeks after surgery ]
    clinical examination

  2. pain after Surgery [ Time Frame: 4-12-52 weeks after surgery ]
    clinical examination, questionnaire, VAS

  3. Recurrence [ Time Frame: 4-12-52 weeks after surgery ]
    clinical examination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • Primary and recurrent inguinal Hernia
  • Age>18ys
  • using 3D devices

Exclusion Criteria:

- Age under 18 ys.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315209


Sponsors and Collaborators
University of Magdeburg
Investigators
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Principal Investigator: Andreas Koch, MD, FACS Institute for Quality Assurance in Operative Medicine
Study Chair: Ralph Lorenz, MD Institute for Quality Assurance in Operative Medicine

Additional Information:

Publications:
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Responsible Party: Dr.Andreas Koch MD, FACS, Member of the Scientific Board, University of Magdeburg
ClinicalTrials.gov Identifier: NCT02315209     History of Changes
Other Study ID Numbers: GR13-108
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Dr.Andreas Koch MD, FACS, University of Magdeburg:
Inguinal Hernia, Quality of Life, Mesh

Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal