Secondary outcome measures
| Outcome measure | Definition |
|---|---|
| Time until identification of the CD | Time in minutes |
| Time until identification of CBD | Time in minutes |
| Time until identification of the transition of CD into the gallbladder | Time in minutes |
| Time until identification of the transition of the CA into the gallbladder | Time in minutes |
| Total surgical time | Time in minutes from skin incision to the end of skin closure |
| Visualisation of CVS and visualisation of the transition of the CD and CA into the gallbladder | Time in minutes |
| Intraoperative bile leakage from the gallbladder or CD | Visualised bile leakage or spill during surgery |
| Bile duct injury | Any injury to the main biliary tree; will be classified using the Strasberg Classification System13 Type A: injury to the CD or from minor hepatic ducts draining the liver bed Type B: occlusion of biliary tree, commonly aberrant right hepatic duct(s) Type C: transection without ligation of aberrant right hepatic duct(s) Type D: lateral injury to a major bile duct Type E:1–5 injury to the main hepatic duct; classified according to level of injury |
| Postoperative length of hospital stay | Duration from date of admission (included) to date of discharge (included) |
| Complications due to injected contrast agent | Any complication potentially caused by injected ICG |
| Conversion to open cholecystectomy | Laparoscopic approach converted to an open operation, or in which an abdominal incision to assist the procedure was needed |
| 90-day all-cause postoperative complications | Any complication, up to 90 days, described by the Clavien-Dindo classification of postoperative complications.39 Specific attention to bile leak, CBD injury, wound infection, intra-abdominal collection, pancreatitis, CBD stones, ICU/HDU readmissions; prospectively assessed during admission; thereafter immediately to be reported to study coordinator |
| Cost minimisation | Difference in costs (in Euros) between conventional LC and NIRF-LC |
CA, cystic artery; CBD, common bile duct; CD, cystic duct; CVS, critical view of safety; LC, laparoscopic cholecystectomy; NIRF, near-infrared fluorescence.