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Table 1 Secondary endpoints and definitions

From: Use of human fibrin glue (Ti sseel) versus sta ples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty (TISTA): a randomized controlled trial (NCT01641718)

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)