Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial

Table 1 Standard protocol items

	V1 Baseline M-1	Hospitalization			V2 1 month follow-up +/− 7 days	V3 3 months follow-up +/− 7 days	V4 6 months follow-up +/− 7 days
	V1 Baseline M-1	D-1	Discharge	D0	V2 1 month follow-up +/− 7 days	V3 3 months follow-up +/− 7 days	V4 6 months follow-up +/− 7 days
Patient information	✓
Informed consent	✓
Verification of eligibility criteria	✓
Randomization	✓
Clinical examination	✓					✓	✓
Complete biological check-up		✓			✓
CBEU	✓				✓	✓	✓
PSA	✓					✓	✓
Ultrasound: measurement of prostatic volume and post-voiding residual	✓					✓
Uroflowmetry: measurement of Qmax	✓					✓	✓
IPSS and USP questionnaires	✓				✓	✓	✓
Collection of patient data	✓
Collection of operative data				✓
Scores: CHA₂DS₂-VASc, HAS-BLED, ATRIA bleeding risk		✓			✓
Collection of treatments	✓			✓	✓	✓	✓
Collection of adverse events			✓	✓	✓	✓	✓

ISSN: 1745-6215