In daily practice there are many treatment modalities for hemorrhoids available. Since many years the rubberband ligation is widly used. Recently there are also positive results reported of the artery ligation procedure. This research aims to…
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primairy endpoint is defined as a succesful treatment out of patient
perpective. A treatment is considered succesful if the number one complaints
has subsided.
Secondary outcome
Secundairy endpoints are
• cost effectivity
- number of treatments neccesary
- number of clinical visits
- number of days not able to work
- number of days of hospitalisation
• postoperative pain
•Amount of painmedication used post operative
•Post operative complication in the first week after the procedure and during 6
months of follow-up
•Number of re-interventions
Background summary
The aim of this study is to determine which of the two commen treatment
modalities of hemorrhoids known as rubberband liagtion and arterie ligation
procedure is best fot the treatment of grade II or III hemorrhoids.
Study objective
In daily practice there are many treatment modalities for hemorrhoids
available. Since many years the rubberband ligation is widly used. Recently
there are also positive results reported of the artery ligation procedure. This
research aims to determine best practice in the treatment of grade II and III
hemorrhoids.
Study design
Prospective randomised multicenter study
Intervention
Patients are either treated with the rubberband ligationprocedure or with the
artery ligation procedure.
Study burden and risks
Both procedures are standard procedures. There are no additional risks in
participation in this study.
Wernaarseind 70
3995 BB Houten
NL
Wernaarseind 70
3995 BB Houten
NL
Listed location countries
Age
Inclusion criteria
- By means of proctoscopy, physical examnination or sigmoidoscopy proved grade II or III hemorrhoids
- No other explanation for rectal bloodloss
- age between 18 and 70 years
- Patient understands the Dutch language
- Patient is able to decide
- informed consent
Exclusion criteria
- grade I or IV hemorrhoids
- asymptomatic hemorrhoids
- other proctologic disorders
- coagulapathy
- use of coumarine derivates
- anal surgery in history
Design
Recruitment
Medical products/devices used
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 | NL26912.100.09 |