HEMARTY Hemorrhoid Artery Minimalisation A Randomized Trial of a ligation Therapy (Doppler guided HAL versus non-doppler guided HAL procedure)

HEMARTY Hemorrhoid Artery Minimalisation A Randomized Trial of a ligation Therapy (Doppler guided HAL versus non-doppler guided HAL procedure) - HEMARTY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30975

Enrollment

100

Registered

2008-01-29

Start date

2008-02-25

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

piles

Interventions

First group is treated with the HAL procedure with doppler. The second group is treated with the HAL procedure without doppler.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age above 18 years Complains for more than 3 months of haemorrhoid related complains Haemorrhoid Grade 2 resistant to rubber band ligation Haemorrhoid Grade 3 ASA 1 and 2

Exclusion criteria

Exclusion criteria: Previous gastro-intestinal malignancy Previous surgery in the rectum including treatment for haemorrhoids within the last 10 years. Simultaneously presence of other anal disorders, such as anal fissure, fistula, abscess, colon/anus carcinoma Unable to understand instructions (eg. Language barrier)

Design outcomes

Primary

Measure	Time frame
Cost effectiveness analyses of the artery ligations procedures.	—

Secondary

Measure	Time frame
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. Next to the changes in rectal compliance in both groups as measured with anal manometry before and after the procedure. Other secondary parameter/endpoints involve the next items • The duration of the procedure • Post operative complications (VAS score) • Post operative pain	—

Measure

Time frame

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. Next to the changes in rectal compliance in both groups as measured with anal manometry before and after the procedure. Other secondary parameter/endpoints involve the next items • The duration of the procedure • Post operative complications (VAS score) • Post operative pain

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)