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
Protocol serial number	004
Sponsor	Individual Sponsor (Germany)
Funder	Chemische Fabrik Kreussler & Co. GmbH (Germany)

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 of protocol

Not provided at time of registration

Contact information

Dr Karl-Heinz Moser
Scientific

Chirurgische Gemeinschaftspraxis Südstadt
Karolingerring 31
Cologne
D 50678
Germany

Study information

Primary study design	Interventional
Study design	Randomised-controlled observer-blinded trial
Secondary study design	Randomised controlled trial
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 objectives	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).
Health condition(s) or problem(s) studied	Bleeding first-grade haemorrhoids
Intervention	Sclerotherapy using either Aethoxysklerol® foam or fluid.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Aethoxysklerol® foam or fluid
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/09/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	130
Key inclusion criteria	Bleeding from first-grade haemorrhoids
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	30/09/2007

Locations

Countries of recruitment

Germany

Study participating centre

Chirurgische Gemeinschaftspraxis Südstadt

Cologne
D 50678
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.