No registrations found.
ID
Source
Brief title
Health condition
Hemorrhoids, piles, THD, HAL, rubberband ligation.
Hemorroïden, aambeien, THD, HAL, Rubberband ligatie
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
In daily practice there are many treatment modalities for hemorrhoids available. Since many years the rubberband ligation is widly used. Recently there are also positive results reported of the artery ligation procedure. This research aims to determine best practice in the treatment of grade II and III hemorrhoids.
The aim of this study is to determine which of the two commen treatment modalities of hemorrhoids known as rubberband liagtion and arterie ligation procedure is best fot the treatment of grade II or III hemorrhoids.
Study objective
In daily practice there are many treatment modalities for hemorrhoids available. Since many years the rubberband ligation is widly used. Recently there are also positive results reported of the artery ligation procedure. This research aims to determine best practice in the treatment of grade II and III hemorrhoids.
Study design
Follow-up at 6 weeks, and 6 months.
Intervention
Patients are either treated with the rubberband ligationprocedure or with the artery ligation procedure.
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. 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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1999 |
| NTR-old | NTR2116 |
| Other | CCMO : ABR26912 / NL26912.100.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |