Trial document




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  DRKS00017127

Trial Description

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Title

Functional Outcome and Quality of life after Total Extra-Peritoneal Inguinal Hernia Repair with Double Mesh Technique

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Trial Acronym

Hernia-Motion

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URL of the Trial

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Brief Summary in Lay Language

Groin pain can be caused by several different musculoskeletal disorders. Regardless of the underlying cause, pain patterns are often comparable and in many cases surgery of some kind is needed to achieve pain relief. In the evaluation of overall surgical success the patient perspective is a very important aspect. Hence, quality of life functional deficit changes, and patient satisfaction after a surgical procedure are of major interest. For the assessment of groin pain related quality of life and physical function, the use of groin-specific health-related patient self-reported outcome measures are recommended. Yet, no such specific health-related patient self-reported outcome measures was available in the German language until just recently. Lately, German versions of two groin-specific health-related patient self-reported outcome measures have been established, but not yet validated.
The main goal of this prospective cross-sectional study is to evaluate patients quality of life and functional outcome in terms of increased hip range of motion and muscle strength after inguinal hernia repair in a modified Total Extraperitoneal Patch Plasty with double mesh technique. Yet, to be able to comprehensively evaluate groin-related quality of life and physical function, psychometric properties of the two currently available German groin-pain specific health-related patient self-reported outcome measures Copenhagen Hip and Groin Outcome Score in german and Carolinas Comfort
Scale-German version, have first to be evaluated. This will be done at the same time and in the same patient cohort. Thus, data collection will include questionnaires and clinical testing at five different time points in patients undergoing an elective hernia surgery in double mesh technique. It is hypothesized that psychometric properties of both groin-specific health-related patient self-reported outcome measures will be sufficient to justify their use in inguinal hernia patients and functional outcome expressed through hip muscle strength and active hip joint range of motion as well as patients quality of life will significantly improve after hernia surgery with double mesh technique.

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Brief Summary in Scientific Language

Groin pain can be caused by several different musculoskeletal disorders. Regardless of the underlying cause, pain patterns are often comparable and in many cases surgery of some kind is needed to achieve pain relief. In the evaluation of overall surgical success, the patient perspective is a very important aspect. Hence, quality of life (QoL), functional deficit changes, and patient satisfaction after a surgical procedure are of major interest. For the assessment of groin pain related QoL and physical function, the use of groin-specific health-related patient self-reported outcome measures (HR-PRO) are recommended. Yet, no such specific HR-PRO was available in the German language until just recently. Lately, German versions of two groin-specific HR-PRO have been established, but not yet validated.
The main goal of this prospective cross-sectional study is to evaluate patients’ QoL and functional outcome in terms of increased hip range of motion (ROM) and muscle strength after inguinal hernia repair in a modified Total Extraperitoneal Patch Plasty (TEP) with double mesh technique.
Yet, to be able to comprehensively evaluate groin-related QoL and physical function, psychometric properties of the two currently available German groin-pain specific HR-PRO, Copenhagen Hip and Groin Outcome Score-deutsche Version (HAGOS-D) and Carolinas Comfort Scale-German version (CCS-G), have first to be evaluated. This will be done at the same time and in the same patient cohort. Thus, data collection will include questionnaires and clinical testing at five different time points in patients undergoing an elective TEP surgery in double mesh technique. It is hypothesized that (1) psychometric properties of both groin-specific HR-PRO will be sufficient to justify their use in inguinal hernia patients and (2) functional outcome expressed through hip muscle strength and active hip joint ROM as well as patients´ QoL will significantly improve after TEP with double mesh technique.

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Organizational Data

  •   DRKS00017127
  •   2019/04/18
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  •   yes
  •   Approved
  •   2018-065, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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Health Condition or Problem studied

  •   K40 -  Inguinal hernia
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Interventions/Observational Groups

  •   All included patients will be provided with questionnaires and/or measured at five different time points (T0-T4; T0: 2 weeks prior to surgery; T1: 1 d prior to surgery; T2: 1 week post surgery; T3: 3 months post surgery; T4: 6 months post surgery) to collect all relevant data. Data collection for PART 1 of this study (i.e. establishing HAGOS-D and CCS-G psychometric properties) will be included in T0, T1 and T3, while the data for PART 2 of this study (i.e. evaluation of functional outcomes and QoL after TEP with double mesh technique) will be collected at all time points (T0-T4). Duration of data collection at each time point will depend on the amount of measurements taken. Patients will have to invest an extra time 15 minutes (shortest duration; T1) and approximately 60 minutes (longest duration; T0).
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The main goal of this prospective cross-sectional study is to evaluate patients’ QoL and functional outcome in terms of increased hip range of motion (ROM) and muscle strength after inguinal hernia repair in a modified Total Extraperitoneal Patch Plasty (TEP) with double mesh technique.Hence, this study comprises a PART 1-“HR-PRO psychometric properties assessment” and a PART 2-“QoL and functional outcome measures”.

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Secondary Outcome

In addition, QoL and functional deficit changes in terms of increased hip range of motion (ROM) and muscle strength have not yet been measured after TEP with double mesh technique. To be able to evaluate this, the psychometric properties in terms of validity, reliability and responsiveness of the two aforementioned groin pain specific HR-PRO, HAGOS-D (Copenhagen Hip and Groin Outcome Score-deutsche Version) and CCS-G (Carolinas Comfort Scale-German version), have first to be evaluated. This will be done at the same time and in the same patient cohort as data collection for the functional outcome after surgery evaluation. Hence, this study comprises a PART 1-“HR-PRO psychometric properties assessment” and a PART 2-“QoL and functional outcome measures”.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/05/02
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

(1) age 18-65 years, (2) male or female (3) groin pain for a minimum of two weeks before inclusion in the study, (4) presence of an inguinal groin hernia justifying elective TEP with double mesh implantation; (5) pain intensity >2/10 on a Visual Analogue Scale (VAS).

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Exclusion Criteria

(1) inability to sufficiently understand and read German, (2) emergency operations of inguinal groin hernia, (3) history of abdominal, groin or lower limb joints surgery 12 months prior to the study, (5) presence of a total hip arthroplasty, (6) history of previous inguinal mesh implantation on the affected side, (7) history of any neurological condition that could impair lower extremity function (e.g. spasticity, Parkinson´s disease), (8) pregnancy.

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Addresses

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    • Universitätsklinik für Viszeralchirurgie, Pius-Hospital Oldenburg
    • Mr.  Dr. med.  Dirk  Weyhe 
    • Georgstr. 12
    • 26121  Oldenburg
    • Germany
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    • Universitätsklinik für Viszeralchirurgie, Pius-Hospital Oldenburg
    • Ms.  Dr.  Verena  Uslar 
    • Georgstrasse 12
    • 26122  Oldenburg
    • Germany
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    • Universitätsklinik für Viszeralchirurgie, Pius- Hospital Oldenburg
    • Mr.  Gerasimos  Nanos 
    • Georgstrasse 12
    • 26122  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Carl von Ossietzky Universität Oldenburg Fakultät VI - Medizin und Gesundheitswissenschaften
    • Ammerländer Heerstrasse 114-118
    • 26129  Oldenburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.