Table 1.
The schedule of enrollment, interventions, and assessments (according to the SPIRIT statement 2013)
| TIME POINT | STUDY PERIOD | |||||
|---|---|---|---|---|---|---|
| Enrollment | Allocationa | Post-allocation | Close-out | |||
| October 2017 – December 2019 | 0 | t1b | t2b | t3b | 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