The surplus value of doppler in haemorrhoid artery ligation procedure
| ISRCTN | ISRCTN58162568 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58162568 |
| Protocol serial number | N/A |
| Sponsor | Catharina Hospital Eindhoven (The Netherlands) |
| Funder | Catharina Hospital Eindhoven (The Netherlands) |
- Submission date
- 23/08/2007
- Registration date
- 23/08/2007
- Last edited
- 28/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S. Nienhuijs
Scientific
Scientific
Canisius-Wilhelmina Hospital
P.O. Box 9015
Nijmegen
6500 GS
Netherlands
| Phone | +31 (0)24 365 7657 |
|---|---|
| s.nienhuijs@hccnet.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Standard localised ligations are as feasible as doppler-guided ligations of haemorrhoid arteries. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee (Medisch-Ethische toetsingscommissie) on the 24th of May 2007 (ref: METC number M071729). |
| Health condition(s) or problem(s) studied | Haemorrhoid arteries |
| Intervention | Doppler-guided and standard localised haemorrhoidal artery ligation. |
| Intervention type | Other |
| Primary outcome measure(s) |
Incontinence at four months postoperatively. |
| Key secondary outcome measure(s) |
1. Operative variables |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 92 |
| Key inclusion criteria | 1. Aged greater than 18 years 2. Symptomatic grade II/III/IV haemorrhoids 3. At least one unsuccessful rubber band ligation 4. Informed consent |
| Key exclusion criteria | 1. Previous anal surgery 2. Bleeding disorder |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Canisius-Wilhelmina Hospital
Nijmegen
6500 GS
Netherlands
6500 GS
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
