Table 1 Secondary endpoints of the HAPERPACT trial
Secondary endpoints | Definitions |
|---|---|
Warm ischemia time | From the time of clamping the first renal artery in situ to flushing the kidney with chilled solution on the back table (minutes) |
Intraoperative complications | Any complication occurring during the operation |
Estimated blood loss | The entire blood loss from skin incision to skin closure (milliliters) |
Operating time | From the time of skin incision to closure of the skin incision (minutes) |
Postoperative pain | Severity of pain measured by the 11-point visual analog scale (0 = no pain and 10 = unbearable distress) |
Rescue analgesic | Total amount of analgesics required during the first three postoperative days |
Peak expiratory flow rate (PEFR) | Maximum speed of expiration, measured with a peak flow meter |
Postoperative complications | Postoperative surgical complications (i.e., burst abdomen and hernia, wound infection, seroma, and hematoma, intra-abdominal bleeding/hematoma, intra-abdominal abscess or collection, lymphocele, and postoperative ileus) and medical complications (pneumonia, pleural effusion, urinary tract infection). Each complication will be graded according to the Clavien-Dindo classification [29] |
Length of hospital stay | From the day of the operation until the day of discharge (days) |
Time to return to work | The number of days from discharge to return to work |
IPAQ-SF score* | The physical activity of patients will be evaluated preoperatively, and on postoperative weeks 1, 2, 4, and 8 using the IPAQ-SF [18] |
Patient satisfaction score | Patient satisfaction score measured by the 5-point Likert scale (5 = strongly satisfied and 1 = strongly unsatisfied) |
Cosmetic score | Cosmetic score as defined by the Stony Brook Scar Evaluation Scale [20] |
Incisional hernia | Fascia or muscle defect (bulging hernial sac and palpable fascia gap) at the site of the surgical incision examined by palpation and ultrasonography |
Mortality | Death due to any cause at any time during the follow-up period |
Primary non-function (PNF) | The graft never functions |
Delayed graft function (DGF) | The need for one or more hemodialysis treatments following transplantation prior to the onset of graft function. The duration of DGF will be calculated from the date of transplantation to the date of the last dialysis treatment |
Recipient serum creatinine level | Serum creatinine level (mg/dL) |
Glomerular filtration rate (GFR) | GFR (mL/min/1.73 m2) calculated as 175 × (Scr)–1.154 × (Age)–0.203 × (0.742 if female) |