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.

Completed

• Conditions: Hemorrhoids; piles; 10002112

• Registration Number: NL-OMON33371
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- By means of proctoscopy, physical examnination or sigmoidoscopy proved grade II or III hemorrhoids
- No other explanation for rectal bloodloss
- age between 18 and 70 years
- Patient understands the Dutch language
- Patient is able to decide
- informed consent

Exclusion Criteria

- grade I or IV hemorrhoids
- asymptomatic hemorrhoids
- other proctologic disorders
- coagulapathy
- use of coumarine derivates
- anal surgery in history

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primairy endpoint is defined as a succesful treatment out of patient<br /><br>perpective. A treatment is considered succesful if the number one complaints<br /><br>has subsided. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundairy endpoints are<br /><br>• cost effectivity<br /><br>- number of treatments neccesary<br /><br>- number of clinical visits<br /><br>- number of days not able to work<br /><br>- number of days of hospitalisation<br /><br>• postoperative pain<br /><br>•Amount of painmedication used post operative<br /><br>•Post operative complication in the first week after the procedure and during 6<br /><br>months of follow-up<br /><br>•Number of re-interventions</p><br>