Secondary endpoints | Definitions |
---|---|
Pain rated before surgery and at 4, 8, 12, 36, 48 h after surgery | Measured on a numeric rating scale from 0-10 at rest and upon bending the hip joint on the operated side |
Operating time | Time, in minutes, from the first skin incision to the application of dressing |
Length of hospital stay | Time, in days (with one decimal precision), from start of surgery to hospital release |
Postoperative analgesic requirements | Amount (g/day) and type (paracetamol, metamizole, morphine) of analgesic required after surgery, before hospital discharge |
Incidence of persistent pain (neuralgia) | Neuralgia defined as: |
• The presence of intermittent hyperesthesia, burning sensation, or jabbing pain in the ipsilateral, inguinal area nerves (genitofemoral nerve, lateral cutaneous femoral nerve, ilioinguinal and iliohypogastric nerve)[20, 22, 27] | |
• Evaluation will be performed 14 days, 1, 3 and 12 months after surgery | |
• The degree of pain will measured as described above | |
Postoperative morbidity | Categorized according to Dindo et al[28], and it includes: |
• Wound infection, defined as infections treated without further surgery and identified by clinical examination without microbiological confirmation | |
• Hematoma or seroma formation, identified by clinical examination alone, before discharge from hospital, which does not require radiological confirmation | |
• Re-operation, defined as the need for re-operation during the initial hospital stay | |
• Bleeding | |
• Urinary retention, urinary tract infection | |
• Pulmonary infection | |
• Any serious deviation from the normal postoperative course | |
Time to return to normal activities | Time, in days, from hospital discharge to first working day |
Relapse | Within 1 year of surgery |
Economic impact | Calculated based on the following factors: |
• Cost for glue, staples, and instruments to apply glue or staples | |
• If relevant: cost for excess operating time for the “slower” mesh fixation | |
• Length of hospital stay (cost/day) | |
• Medical leave of absence (converted into a monetary amount based on an average salary) |