Comparison of sclerotherapy for first-grade haemorrhoids using aethoxysklerol® foam versus fluid: a randomised, controlled, multicentre, single-blinded trial

INTERVENTION: Sclerotherapy using either Aethoxysklerol® foam or fluid. CONDITION: Bleeding first‐grade haemorrhoids ; Circulatory System ; Haemorrhoids PRIMARY OUTCOME: Percentage of patients reporting persistant haemorrhoidal bleeding after the first sclerotherapy session. Patients will score bleeding in a daily fashion using a calendar. Persistant bleeding is defined as two days with bleeding in the interval after day two following sclerotherapy, or as one day with bleeding within the last three days before the follow‐up visit on day 14. SECONDARY OUTCOME: 1. Number of courses of repeat sclerotherapy; 2. Percentage of patients with bleeding after a second sclerotherapy; 3. Size of haemorrhoids; 4. Total volume of Aethoxysklerol® necessary for therapy; 5. Pain during and after therapy; 6. Pruritus ani; 7. Feeling of perianal wetness; 8. Patient satisfaction; 9. Perianal interventions other than sclerotherapy; 10. Incidence of adverse events INCLUSION CRITERIA: Bleeding from first‐grade haemorrhoids