Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological Puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients

Table 1 Study visit schedule

			Follow-up
	Day of screening	Day of operation	Visit 1 (day 90 post OP) by phone
Past medical history*	X
Informed consent	X
Personal data**	X
Examination of primary endpoints:
• Success of randomized implantation technique		X
Examination of secondary endpoints:
• Peri- and postoperative complications		X	X
• Times of port implantation procedure		X
• Dose of radiation		X
Savety criteria AE, SAE (2.6)		X	X

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

ISSN: 1745-6215