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,…
ID
Bron
Verkorte titel
Aandoening
Hemorrhoids - hemorroïden
Piles - aambeien
Ondersteuning
Koekoekslaan 1
3430 EM Nieuwegein
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Cost effectiveness analyses of the artery ligations procedures.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
1. Preoperative screening;
2. 6 weeks after intervention;
3. 6 months after intervention.
Onderzoeksproduct en/of interventie
First group is treated with the HAL procedure with doppler. The second group is treated with the HAL procedure without doppler.
Algemeen / deelnemers
Jaap-Peter Schuurman
Nieuwegein 3430 EM
The Netherlands
+31 (0)88 320 30 00
j.schuurman@antonius.net
Wetenschappers
Jaap-Peter Schuurman
Nieuwegein 3430 EM
The Netherlands
+31 (0)88 320 30 00
j.schuurman@antonius.net
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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 .
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2022 |
| NTR-old | NTR2139 |
| CCMO | NL17145.100.07 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON30975 |