To establish the best treatment of patients with symptomatic haemorrhoids grade III: haemorrhoidectomy versus rubber band ligation (RBL). Patient bound effectiveness, clinical effectiveness and cost-utility of both treatments is…
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Health condition
Haemorrhoids graad III.
Research involving
Sponsors and support
Intervention
- Surigical procedure
Outcome measures
Primary outcome
Secondary outcome
Background summary
half of the general population. Given the current numerous modalities the obvious question
which needs to be answered is which treatment is the best. An interesting conclusion from a
recent systematic review regarding operative procedures for haemorrhoidal disease is that all
procedures have their own advantages and disadvantages. There is a need for evaluating
treatment from the patient’s point of view and transparency in surgical and non-surgical
treatment outcome. So far there is no sufficiently large trial that meets that demand.
Study objective
haemorrhoidectomy versus rubber band ligation (RBL). Patient bound effectiveness, clinical
effectiveness and cost-utility of both treatments is compared; primary outcome is quality of life
at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post
procedure. The assumption is that treatment with rubber band ligation is equally effective in
comparison with haemorrhoidectomy in terms of quality of life.
Study design
Two treatment protocols are compared: haemorrhoidectomy and rubber band ligation
Intervention
Rubber band ligation versus haemorrhoidectomy
Study burden and risks
by rubber band ligation and haemorrhoidectomy. Patients will not have extra hospital visits.
Patients will be asked to complete 8 questionnaires on 6 different occasions (6 x 10 minutes):
at baseline, at 1 and 6 weeks and 6, 12 and 24 months after surgery. The content includes
general and disease specific QOL, health related costs, subjective cure and adherence to
therapy. We do not expect any adverse reactions or events in respect to participation in the
study because both procedures are considered standard care.
Justin van Oostendorp
Prof. Bronkhorstlaan 10, gebouw 60-62
3723 MB
Bilthoven
Nederland
0613780223
j.vanoostendorp@proctoskliniek.nl
Justin van Oostendorp
Prof. Bronkhorstlaan 10, gebouw 60-62
3723 MB
Bilthoven
Nederland
0613780223
j.vanoostendorp@proctoskliniek.nl
Age
Inclusion criteria
• Hemorrhoids grade III (Goligher classification) • Age 18 years and older • Sufficient understanding of the Dutch written language (reading and writing)
Exclusion criteria
• Previous rectal or anal surgery with the exception of rubber band ligation • Previous surgery for haemorrhoids (at any time) • More than one injection treatment for haemorrhoids in the past 3 years • More than one rubber band ligation procedure in the past 3 years • Previous rectal radiation • Pre-existing sphincter injury • Inflammatory bowel disease • Medically unfit for surgery or for completion of the trial (ASA>III) • Pregnancy • Hyper-coagulability disorders • Therapy with Warfarin, Clopidogrel or oral anticoagulance • Patients previously randomised to this trial • Not able or willing to provide written informed consent
Design
Recruitment
IPD sharing statement
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8020 |
| CCMO | NL69227.018.19 |
| OMON | NL-OMON55719 |