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

Recruiting

Conditions: K40
Inguinal hernia

Registration Number: DRKS00017127

Lead Sponsor: niversitätsklinik für Viszeralchirurgie, Pius-Hospital Oldenburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

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

(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.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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”.