The surplus value of doppler in haemorrhoid artery ligation procedure
| ISRCTN | ISRCTN58162568 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58162568 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Randomised, double-blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | Incontinence at four months postoperatively. |
| Secondary outcome measures | 1. Operative variables 2. Visual Analogue Scale (VAS)-pain scores, analgesics (seven days, month one and four) 3. Cleveland Incontinence Score, Complaints (month one and four) 4. Costs |
| Overall study start date | 01/08/2007 |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 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
Sponsor information
Catharina Hospital Eindhoven (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
P.O. Box 1350
Eindhoven
5602 ZA
Netherlands
| Website | http://www.catharina-ziekenhuis.nl/ |
|---|---|
"ROR" |
https://ror.org/01qavk531 |
Funders
Funder type
Hospital/treatment centre
Catharina Hospital Eindhoven (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
