Skip to content

Prospectief gerandomiseerd multicenter vergelijkend onderzoek tussen het gebruik van rubberband ligatie en arterie ligatie van de hemorroïdaal arteriën voor de behandeling van graad II en III hemorroïden.

Prospective 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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27930
Enrollment
200
Registered
2009-11-18
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Hemorrhoids, piles, THD, HAL, rubberband ligation. Hemorroïden, aambeien, THD, HAL, Rubberband ligatie

Interventions

Patients are either treated with the rubberband ligationprocedure or with the artery ligation procedure.

Sponsors

St. Antonius Ziekenhuis, Nieuwegein, Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. Grade I or IV hemorrhoids; 2. Asymptomatic hemorrhoids; 3. Other proctologic disorders; 4. Coagulapathy; 5. Use of coumarine derivates; 6. Anal surgery in history.

Design outcomes

Primary

MeasureTime frame
Primairy endpoint is defined as a succesful treatment out of patient perpective. A treatment is considered succesful if the number one complaints has subsided.

Secondary

MeasureTime frame
Secundairy 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.

Contacts

Public ContactJaap-Peter Schuurman

Postbus 2500

j.schuurman@antonius.net+31 (0)88 320 30 00

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)