We want to compare the effectiveness of sclerotherapy and rubberband ligation when it comes to symptoms. We will secondarily consider patient satisfaction, complications and recurrences. We hypothesize that both treatments are equally effective.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
symptoms (ESCP core outcomes): pain, bloodloss, itchiness, prolapse
Secondary outcome
satisfaction, treatment numbers, cross-over, work-leave
Background summary
Hemorrhoids are a frequent problem in society; it is a problem that can be
treated with rubberband ligation or sclerotherapy. Until now there has not been
a randomised controlled trial which looks at effectiveness and patient
satisfaction of these treatments.
Study objective
We want to compare the effectiveness of sclerotherapy and rubberband ligation
when it comes to symptoms. We will secondarily consider patient satisfaction,
complications and recurrences. We hypothesize that both treatments are equally
effective.
Study design
randomised controlled trial, multicenter
Intervention
Intervention: Sclerotherapy - 2 injections aethoxysklerol 3% (polidocanol)
(Control: Rubberband ligation, 3 rubberbands per session)
Study burden and risks
3 moments to fill in questionnaires; roughly 10-20min per session.
The rest of the treatment is the usual protocol
Hospitaalweg 1
Almere 1315RA
NL
Hospitaalweg 1
Almere 1315RA
NL
Listed location countries
Age
Inclusion criteria
grade 1 or 2 hemorrhoids, >18 years old
Exclusion criteria
grade 3-4 hemorrhoids, treatment for hemorrhoids in the last year
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73111.018.20 |
| Other | NL8377 |