K40
Conditions
Interventions
Group 1: 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
T1) and approximately 60 minutes (longest duration
T0).
Sponsors
Universitätsklinik für Viszeralchirurgie, Pius-Hospital Oldenburg
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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).
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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”. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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”. | — |
Countries
Germany
Contacts
Public ContactGerasimos Nanos
Universitätsklinik für Viszeralchirurgie, Pius- Hospital Oldenburg
Outcome results
None listed