Bleeding first-grade haemorrhoids Circulatory System Haemorrhoids
Conditions
Interventions
Sclerotherapy using either Aethoxysklerol® foam or fluid.
Sponsors
Individual Sponsor (Germany)
Eligibility
Inclusion criteria
Inclusion criteria: Bleeding from first-grade haemorrhoids
Exclusion criteria
Exclusion criteria: 1. Age under 18 or over 75 years 2. Pregnancy or breast-feeding 3. Allergy to polidocanol or other drug components 4. Perianal thrombosis 5. Faecal incontinence 6. Perianal fistula 7. Proctitis 8. Periproctal abscess 9. Anal eczema 10. Previous sclerotherapy for haemorrhoids 11. General allergic predisposition 12. Asthma bronchiale 13. Perianal bleeding from other causes than haemorrhoids 14. Severe general comorbidity hindering follow-up 15. Hypercoagulability 16. Concomitant anticoagulatory medication 17. Hereditary thrombophilia 18. Hepatitis B or C 19. Human Immunodeficiency Virus (HIV) infection 20. Crohn's disease 21. Colitis ulcerosa 22. Diabetes mellitus type I or II 23. Known gastrointestinal cancer 24. General infection 25. Participation in another drug trial within the last 30 days 26. Legal or illegal drug dependency interfering with study compliance 27. Lack of German language proficiency 28. Lack of self-determination due to legal or authorative adjudication 29. Psychoneurological disorders interfering with study compliance 30. Lack of compliance 31. Lack of written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed