Condition category
Circulatory System
Date applied
12/12/2006
Date assigned
05/03/2007
Last edited
05/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karl-Heinz Moser

ORCID ID

Contact details

Chirurgische Gemeinschaftspraxis Südstadt
Karolingerring 31
Cologne
D 50678
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

004

Study information

Scientific title

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

Approval pending from the local ethics committee (Ethikkommission der Ärztekammer Nordrhein).

Study design

Randomised-controlled observer-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Bleeding first-grade haemorrhoids

Intervention

Sclerotherapy using either Aethoxysklerol® foam or fluid.

Intervention type

Drug

Phase

Not Specified

Drug names

Aethoxysklerol® foam or fluid

Primary outcome measures

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 trial start date

01/01/2007

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Bleeding from first-grade haemorrhoids

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

130

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

Trial participating centre

Chirurgische Gemeinschaftspraxis Südstadt
Cologne
D 50678
Germany

Sponsor information

Organisation

Individual Sponsor (Germany)

Sponsor details

Karl-Heinz Moser
Chirurgische Gemeinschaftspraxis Südstadt
Karolingerring 31
Cologne
D 50678
Germany

Sponsor type

Other

Website

Funders

Funder type

Industry

Funder name

Chemische Fabrik Kreussler & Co. GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes