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.
- Conditions
- Hemorrhoids, piles, THD, HAL, rubberband ligation.Hemorroïden, aambeien, THD, HAL, Rubberband ligatie
- Registration Number
- NL-OMON27930
- Lead Sponsor
- St. Antonius Ziekenhuis, Nieuwegein, Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. By means of proctoscopy, physical examnination or sigmoidoscopy proved grade II or III hemorrhoids;
2. No other explanation for rectal bloodloss;
Exclusion Criteria
1. Grade I or IV hemorrhoids;
2. Asymptomatic hemorrhoids;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secundairy endpoints are:<br /><br>1. Cost effectivity;<br /><br>2. Number of treatments neccesary;<br /><br>3. Number of clinical visits;<br /><br>4. Number of days not able to work;<br /><br>5. Number of days of hospitalisation;<br /><br>6. Postoperative pain;<br /><br>7. Amount of painmedication used post operative;<br /><br>8. Post operative complication in the first week after the procedure and during 6 months of follow-up;<br /><br>9. Number of re-interventions.