Bleeding first-grade haemorrhoids
Conditions
Interventions
Trade Name: Aethoxysklerol® 3%
Pharmaceutical Form: Injection*
INN or Proposed INN: Macrogolaurylether (Ph. Eur.) (Polidocanol)
Concentration unit: % (W/V) percent weight/volume
Concentration type: eq
Sponsors
Chirurgische Gemeinschaftspraxis Südstadt
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Bleeding from first-grade haemorrhoids Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Age under 18 or over 75 years; pregnancy or breastfeeding; allergy to polidocanol or other drug components; perianal thrombosis; faecal incontinence; perianal fistula; proctitis; periproctal abscess; anal ekzema; sclerotherapy for haemorrhoids within the last 12 months; general allergic predisposition; asthma bronchiale; peranal bleeding from other causes than haemorrhoids; severe general comorbidity hindering follow-up; hypercoagulability; concomitant anticoagulatory medication; hereditary thrombophilia; hepatitis B or C; HIV infection; Crohn's disease; colitis ulcerosa; diabetes mellitus type I or II; known gastrointestinal cancer; general infection; participation in another drug trial within the last 30 days; legal or illegal drug dependency interfering with study compliance; lack of German language proficiency; lack of self-determination due to legal or authorative adjudication; psychoneurological disorders interfering with study compliance; lack of compliance; lack of written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether the rate of persisting haemorrhoidal bleeding is different with using Aethoxysklerol® 3% foam versus fluid;Secondary Objective: - Peranal bleeding after second and further sclerotherapy sessions - Pain during and after intervention - Pruritus ani - Patient satisfaction - Adverse events sclerotherapy related (see Studyprotocol page 17);Primary end point(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 2 following sclerotherapy, or as one day with bleeding within the last four days before the follow-up visit on day 14. | — |
Countries
Germany
Outcome results
None listed