Comparison of sclerotherapy for first-grade haemorrhoids using aethoxysklerol® foam versus fluid: a randomised, controlled, multicentre, single-blinded trial
| ISRCTN | ISRCTN66041206 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66041206 |
| Secondary identifying numbers | 004 |
- Submission date
- 12/12/2006
- Registration date
- 05/03/2007
- Last edited
- 20/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Karl-Heinz Moser
Scientific
Scientific
Chirurgische Gemeinschaftspraxis Südstadt
Karolingerring 31
Cologne
D 50678
Germany
Study information
| Study design | Randomised-controlled observer-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Comparison of sclerotherapy for first-grade haemorrhoids using aethoxysklerol® foam versus fluid: a randomised, controlled, multicentre, single-blinded trial |
| Study acronym | Haemorrhoidal sclerotherapy |
| Study hypothesis | To test whether the rate of persisting haemorrhoidal bleeding is different after a single session of infection sclerotherapy using Aethoxysklerol® 3% foam versus fluid. |
| Ethics approval(s) | Approval pending from the local ethics committee (Ethikkommission der Ärztekammer Nordrhein). |
| Condition | Bleeding first-grade haemorrhoids |
| Intervention | Sclerotherapy using either Aethoxysklerol® foam or fluid. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aethoxysklerol® foam or fluid |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/01/2007 |
| Overall study end date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 130 |
| Participant inclusion criteria | Bleeding from first-grade haemorrhoids |
| Participant 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 |
| Recruitment start date | 01/01/2007 |
| Recruitment end date | 30/09/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Chirurgische Gemeinschaftspraxis Südstadt
Cologne
D 50678
Germany
D 50678
Germany
Sponsor information
Individual Sponsor (Germany)
Other
Other
Karl-Heinz Moser
Chirurgische Gemeinschaftspraxis Südstadt
Karolingerring 31
Cologne
D 50678
Germany
Funders
Funder type
Industry
Chemische Fabrik Kreussler & Co. GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/06/2013 | 20/08/2021 | Yes | No |
Editorial Notes
20/08/2021: Publication reference added.
