LigaSure Impact™ versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial

Table 1 Study Visit Schedule

			Follow-up	Follow-up
	Day of screening	Day of operation	Visit 1 (day 30post OP ) by phone	Visit 2-8 (European Pancreas Center)
Past medical history*	X
Informed consent	X
Personal data**	X
Examination of primary endpoints:
Operating time		X
Examination of primary endpoints:
Mortality		X	X	X
Peri- and postoperative complications		X	X	X
Re-intervention			X	X
Intraoperative blood loss		X
Hospital stay			X
Reuptake			X	X
Time of anesthesia pre- and postoperative		X
Intraoperative material consumption		X
Local recurrence				X
Quality of life	X			X
Safety criteria AE, SAE (2.6)		X	X	X

* study-relevant past medical history, past surgical history
** height (cm), weight (kg), gender, Karnowsky-Index, medication of immunsuppresion, antibiotics, chemotherapy

ISSN: 1745-6215