To determine the cost effectiveness of Doppler located arterial ligation and the random plexus ligation procedure in comparing the long term effectiveness of haemorrhoid treatment with regard to disappearance of clinical symptoms.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cost effectiveness analyses of the artery ligations procedures.
Secondary outcome
To establish the reduction of anal blood flow (decrease of vessel diameter) in
both groups as measured with intra anal Duplex before and after the procedure.
Next to the changes in rectal compliance in both groups as measured with anal
manometry before and after the procedure.
Other secondary parameter/endpoints involve the next items
• The duration of the procedure
• Post operative complications (VAS score)
• Post operative pain
Background summary
Since 1995 the hemorrhoidal artery ligation (HAL) has been used for submucosal
ligation of hemorrhoidal arteries by means of an ultrasonographic transducer
(Morinaga et al. 1995). Because of the variations in the local anatomy (Aigner
et al. 2004, 2006) and the presence of a circumferential plexus it is to
believe that precise localisation of a pulsing bloodstream with doppler is not
possible and not necessary. A random ligation (without the specific Doppler
tool) in the plexus hemorrhoidalis should therefore result in comparable long
term results as in the procedure with the Doppler tool and could be more cost
saving.
Study objective
To determine the cost effectiveness of Doppler located arterial ligation and
the random plexus ligation procedure in comparing the long term effectiveness
of haemorrhoid treatment with regard to disappearance of clinical symptoms.
Study design
Prospective single blinded randomized clinical trial
Intervention
First group is treated with the HAL procedure with doppler. The second group is
treated with the HAL procedure without doppler.
Study burden and risks
Before surgery the subjects are submitted for an ultrasound of the anorectum
and for a rectal manometry. After the surgery the subject has to keep up a
VAS-score for one week. Six weeks after surgery the subjects are again
submitted for an ultrasound and manometry.
Regular follow-up is scheduled at 6 weeks after surgery and subsequently 6, 12
and 24 months after surgery. Each follow-up session includes a rectal
examination and a questionnaire (adapted RAND-36) which have to be filled in.
Resulting in a total of 4 visits post operatively to the clinic. The ultrasound
and manometry of the rectum brings along a certain degree of physical
discomfort. There are no specific physiological discomforts associated with
participation.
Koekoekslaan 1
3430 EM Nieuwegein
Nederland
Koekoekslaan 1
3430 EM Nieuwegein
Nederland
Listed location countries
Age
Inclusion criteria
Age above 18 years
Complains for more than 3 months of haemorrhoid related complains
Haemorrhoid Grade 2 resistant to rubber band ligation
Haemorrhoid Grade 3
ASA 1 and 2
Exclusion criteria
Previous gastro-intestinal malignancy
Previous surgery in the rectum including treatment for haemorrhoids within the last 10 years.
Simultaneously presence of other anal disorders, such as anal fissure, fistula, abscess, colon/anus carcinoma
Unable to understand instructions (eg. Language barrier)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL17145.100.07 |
| OMON | NL-OMON23917 |