Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial)

Table 1 The schedule of enrollment, interventions, and assessments (according to the SPIRIT statement 2013)

TIME POINT		STUDY PERIOD
	Enrollment	Allocation^a	Post-allocation			Close-out
	October 2017 – December 2019	0	t₁^b	t₂^b	t₃^b	December 2019 – June 2020.
ENROLLMENT:
Eligibility screen	X
Informed consent	X
Randomization and allocation		X
INTERVENTIONS:
Pelvic Floor Rehabilitation			X
Control group			X
ASSESSMENTS:
Questionnaires to assess study outcomes			X	X	X
Statistical analysis						X

^aAllocation of the intervention/control group takes place 3 months after index surgery without temporary stoma construction or 6 weeks after stoma reversal if initial surgery included stoma construction. Measurement t1 will always take place before randomization/allocation
^bt1 measurement before randomization, t2 primary endpoint (12 weeks after control/intervention period), t3 one year follow-up

ISSN: 1745-6215