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Hemorro´d Arterie Minimalisatie: een gerandomiseerd onderzoek van een ligatie therapie.


- candidate number6799
- NTR NumberNTR2139
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-dec-2009
- Secondary IDsNL17145.100.07 CCMO
- Public TitleHemorro´d Arterie Minimalisatie: een gerandomiseerd onderzoek van een ligatie therapie.
- Scientific TitleHemorrhoid Artery Minimalisation A Randomized Trial of a ligation Therapy (Doppler guided HAL versus non-doppler guided HAL procedure).
- ACRONYMHEMARTY
- hypothesisSince 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.
- Healt Condition(s) or Problem(s) studiedHemorrhoids, Piles
- Inclusion criteria1. Age above 18 years;
2. Complains for more than 3 months of haemorrhoid related complains;
3. Haemorrhoid Grade 2, resistant to rubber band ligation;
4. Haemorrhoid Grade 3;
5. ASA 1 and 2 .
- Exclusion criteria1. Previous gastro-intestinal malignancy;
2. Simultaneously presence of other anal disorders, such as anal fissure, fistula, abscess, colon/anus carcinoma;
3. Unable to understand instructions (eg. Language barrier).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2008
- planned closingdate1-jun-2010
- Target number of participants100
- InterventionsFirst group is treated with the HAL procedure with doppler. The second group is treated with the HAL procedure without doppler.
- Primary outcomeCost effectiveness analyses of the artery ligations procedures.
- Secondary outcome1. 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;
2. Next to the changes in rectal compliance in both groups as measured with anal manometry before and after the procedure;
3. The duration of the procedure;
4. Post operative complications (VAS score);
5. Post operative pain.
- Timepoints1. Preoperative screening;
2. 6 weeks after intervention;
3. 6 months after intervention.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jaap-Peter Schuurman
- CONTACT for SCIENTIFIC QUERIES Jaap-Peter Schuurman
- Sponsor/Initiator Sint Antonius Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
St Antonius Hospital, Nieuwegein
- PublicationsN/A
- Brief summarySince 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.
- Main changes (audit trail)
- RECORD9-dec-2009 - 18-dec-2009


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