The objective is that 6 standard ligation of hemorrhoidal arteries is as effective as doppler guided.
ID
Source
Brief title
Condition
- Gastrointestinal vascular conditions
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
No more symptoms (blood loss, pain, pruritis, prolaps) at six months
postoperatively
Secondary outcome
Incidence of hamorrhages and bladder retentions first 48 hours
Incidence of other repair related complications
VAS pain score day 1-7
VAS overall satisfaction month 1 + 6
Wexner Fecal Incontinence Score month 1+6
Costs
Maybe same questionairre one year postoperatively
Background summary
Hemorrhoids is a frequent encountered disease. Symptoms like blood loss,
pruritis ani, pain and prolaps are incapitative for the patient. If
conservative treatment fails (like diet), an intervention is indicated. First
choice treatment is the rubber-band-ligation. Minimally invasive the base of
the hemorrhoids is ligated resulting in less hemorrhoidal tissue. Second choice
is more painful, the hemorrhoidectomy. There is however an alternative: doppler
guided ligation of the hemorrhoidal artery. Excellent results including less
postoperative pain have been reported. In that literature and our own
experience showed standard 6 loactions of the hemorrhoid arteries. And
sometimes no diminished blood flow is heard with the doppler, although experts
underline this still can be an adequate ligation. Without doppler guidance, 6
standard ligations (at 1,3,5,7,9 and 11 o'clock) could as effective. Additional
advantage would be that the special doppler-proctoscope is not necessary
anymore. In our institute with approximately 150 patients annually, it would
mean a reduction of 45,000 euro in costs.
Study objective
The objective is that 6 standard ligation of hemorrhoidal arteries is as
effective as doppler guided.
Study design
A randomized study
Intervention
A ligation of hemorrhoidal arteries doppler guided or at six standard
localisations.
Study burden and risks
Burden: completing questionnairres, aprroximately 20 min in total
Risk: a possible lower success for complete relief of the symptoms
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
Hemorrhoidal disease
Grade II or III
Symptomatic following two rubber-band-ligation-procedures
Written informed consent
Exclusion criteria
Previous ano-rectal surgery
Known coagulation disorder
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 | NL17426.060.07 |