Leukocyte- and platelet-rich fibrin in endoscopic endonasal skull base reconstruction: study protocol for a multicenter prospective, parallel-group, single-blinded randomized controlled non-inferiority trial

Table 2 Outcome assessment

Procedure	Visit 1 Screening	Visit 2 Allocation	Visit 3 FU1^a	Visit 4 FU 2^b	Visit 5 FU 3^c	Visit 6 FU 4^d
Enrolment
Eligibility screening	X
Informed consent	X
Randomization		X
Interventions
Endoscopic endonasal transsphenoidal surgery		X
Sellar floor reconstruction/closure		X
Assessments
Medical history	X
EQ-5D	X		X	X	X	X
VAS	X		X	X	X	X
SNOT-22 questionnaire	X		X	X	X	X
SBI	X		X	X	X	X
MR imaging	X				X	X
Cost/material		X
Intraoperative CSF leakage		X
Nasal endoscopy to assess CSF leakage			X	X	X	X
Nasal endoscopy to assess wound healing			X	X	X	X
Nasal endoscopy to assess infection			X	X	X	X
Assessment of adverse events		X	X	X	X	X

CSF cerebrospinal fluid, EQ-5D EuroQol-5D, SBI Skull Base Inventory, SNOT-22 Sino-Nasal Outcome Test with 22 items, FU follow-up, VAS visual analog scale
^a2 weeks postoperative
^b4 weeks postoperative
^c3 months postoperative
^d1 year postoperative

ISSN: 1745-6215