Table 2 Participant timeline
Study period | ||||
|---|---|---|---|---|
Enrolment/allocation | Post-allocation | |||
Time point | Baseline (at allocation or by telephone) | 1 week (telephone) | 6 weeks (outpatient clinic) | 6 months (telephone) |
Eligibility screen | X | |||
Informed consent | X | |||
Allocation (RBL/SCL) | X | X | ||
Primary outcomes | ||||
HD symptoms (PROM) | X | X | X | X |
Abscess | X | |||
Urine retention | X | |||
Anal stenosis | X | |||
Incontinence | X | |||
Fistula | X | |||
Recurrence | X | X | ||
Secondary outcomes | ||||
Satisfaction/experience (PREM) | X | |||
Absenteeism | X | (X) | ||
Number of treatments | X | X | ||
Crossover rate | X | |||