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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)