No registrations found.
ID
Source
Brief title
Health condition
Hemorrhoids - hemorroïden
Piles - aambeien
Sponsors and support
Koekoekslaan 1
3430 EM Nieuwegein
Intervention
Outcome measures
Primary outcome
Cost effectiveness analyses of the artery ligations procedures.
Secondary outcome
1. 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.
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
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 design
1. Preoperative screening;
2. 6 weeks after intervention;
3. 6 months after intervention.
Intervention
First group is treated with the HAL procedure with doppler. The second group is treated with the HAL procedure without doppler.
Jaap-Peter Schuurman
Nieuwegein 3430 EM
The Netherlands
+31 (0)88 320 30 00
j.schuurman@antonius.net
Jaap-Peter Schuurman
Nieuwegein 3430 EM
The Netherlands
+31 (0)88 320 30 00
j.schuurman@antonius.net
Inclusion criteria
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 .
Exclusion criteria
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2022 |
| NTR-old | NTR2139 |
| CCMO | NL17145.100.07 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON30975 |