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Prospectief gerandomiseerd multicenter vergelijkend onderzoek tussen het gebruik van rubberband ligatie en arterie ligatie van de hemorro´daal arteriŰn voor de behandeling van graad II en III hemorro´den.


- candidate number6734
- NTR NumberNTR2116
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2009
- Secondary IDsABR26912 / NL26912.100.09  CCMO
- Public TitleProspectief gerandomiseerd multicenter vergelijkend onderzoek tussen het gebruik van rubberband ligatie en arterie ligatie van de hemorro´daal arteriŰn voor de behandeling van graad II en III hemorro´den.
- Scientific TitleProspective randomised multicenter study comparing the outcome of rubberband ligation and artery ligation of the hemorrhoidal arteries in the treatment of grade II and III hemorrhoids.
- ACRONYMHEMO
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedHemorrhoids, Piles
- Inclusion criteria1. By means of proctoscopy, physical examnination or sigmoidoscopy proved grade II or III hemorrhoids;
2. No other explanation for rectal bloodloss;
3. Age between 18 and 70 years;
4. Patient understands the Dutch language;
5. Patient is able to decide;
6. Informed consent.
- Exclusion criteria1. Grade I or IV hemorrhoids;
2. Asymptomatic hemorrhoids;
3. Other proctologic disorders;
4. Coagulapathy;
5. Use of coumarine derivates;
6. Anal surgery in history.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2011
- Target number of participants200
- InterventionsPatients are either treated with the rubberband ligationprocedure or with the artery ligation procedure.
- Primary outcomePrimairy endpoint is defined as a succesful treatment out of patient perpective. A treatment is considered succesful if the number one complaints has subsided.
- Secondary outcomeSecundairy endpoints are:
1. Cost effectivity;
2. Number of treatments neccesary;
3. Number of clinical visits;
4. Number of days not able to work;
5. Number of days of hospitalisation;
6. Postoperative pain;
7. Amount of painmedication used post operative;
8. Post operative complication in the first week after the procedure and during 6 months of follow-up;
9. Number of re-interventions.
- TimepointsFollow-up at 6 weeks, and 6 months.
- Trial web sitewww.hemotrial.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES Jaap-Peter Schuurman
- CONTACT for SCIENTIFIC QUERIES Jaap-Peter Schuurman
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
St Antonius Hospital, Nieuwegein
- PublicationsN/A
- Brief summaryIn 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.
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.
- Main changes (audit trail)
- RECORD18-nov-2009 - 4-dec-2009


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