Table 1 Primary and secondary outcome measures

Primary outcomes

Patient-related outcomes

PROM (minimal score 5, maximum score 25): The lower the score the better the result

 - Blood loss

Likert scale – 1 (not at all) to 5 (very much)

 - Pain

Likert scale – 1 (not at all) to 5 (very much)

 - Prolapse

Likert scale – 1 (not at all) to 5 (very much)

 - Itching

Likert scale – 1 (not at all) to 5 (very much)

 - Soiling

Likert scale – 1 (not at all) to 5 (very much)

HISS (minimal score 0, maximum score 20)

 - Impact on daily activities

Scale – 0 (no impact at all) to 10 (highly impacted on daily activities)

 - Satisfaction with treatment

Scale – 0 (not at all satisfied) to 10 (very satisfied)

Complications

  Incontinence

Wexner Fecal Incontinence Score

  Abscess

Physical examination^a

  Fistulation

Physical examination^a

  Urine retention

Bladder scan

  Anal stenosis

Physical examination^a

  Anal fissure

Physical examination

  Arterial bleeding

Physical examination

  Thrombosed haemorrhoid

Physical examination

Recurrence

Subjective return of initial symptoms

Secondary outcomes

 Patient experience

PREM

 Absenteeism

Days of sick leave from work

 Number of treatments

Numeric

 Crossover rate

Numeric