littekenbreuk Incisional hernia ventral hernia
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years or older - Elective HYDRA-surgery - Midline incisional hernia larger than 4 centimetres in mean width - Sufficient knowledge of the Dutch language to be able to understand and fill in the questionnaires - Signed informed consent form by patient
Exclusion criteria
Exclusion criteria: - Pregnant at inclusion - Inclusion in other trials with interference of the primary and secondary endpoints - ASA >3 - Hernia defect larger than 10 centimetres in mean width - Incarcerated hernias or emergency procedure - Unable to perform a trunk flexion - Incapacitated patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to assess anatomical restoration and function of the linea alba one year after surgery by ultrasonography and measuring the mean peak torque during trunk flexion using a BioDexTM machine. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints will be blood loss, hemostasis, hematoma, intra-operative complications, mesh fixation technique (single crown or double crown), position of the mesh (according to ICAP classification), type of sutures used (absorbable or non-absorbable), serosa injury, enterotomy, time to normal intestinal functioning (days), seroma formation (assessed by ultrasound), time to return to work (weeks), anatomical restoration after two years (ultrasound), abdominal wall function after two years (using BioDexTM), postoperative complications (through Clavien-Dindo classification), use of additional analgesia, CDC assessment, SSI (according to SSO and SSOPI), mesh infections, 30-day reoperation rate, hernia recurrence (through ultrasound), patient satisfaction with their scar after one- and two year(s) (Likert-scale), mesh comfort (by Carolina's Comfort Scale questionnaire), postoperative pain (VAS of pain) and quality of life (SF-36). | — |
Countries
Netherlands
Outcome results
None listed