Contact information
Type
Scientific
Primary contact
Dr S. Nienhuijs
ORCID ID
Contact details
Canisius-Wilhelmina Hospital
P.O. Box 9015
Nijmegen
6500 GS
Netherlands
+31 (0)24 365 7657
s.nienhuijs@hccnet.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Standard localised ligations are as feasible as doppler-guided ligations of haemorrhoid arteries.
Ethics approval
Ethics approval received from the local medical ethics committee (Medisch-Ethische toetsingscommissie) on the 24th of May 2007 (ref: METC number M071729).
Study design
Randomised, double-blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Haemorrhoid arteries
Intervention
Doppler-guided and standard localised haemorrhoidal artery ligation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/08/2007
Overall trial end date
01/12/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
92
Participant exclusion criteria
1. Previous anal surgery
2. Bleeding disorder
Recruitment start date
01/08/2007
Recruitment end date
01/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Canisius-Wilhelmina Hospital
Nijmegen
6500 GS
Netherlands
Sponsor information
Organisation
Catharina Hospital Eindhoven (The Netherlands)
Sponsor details
Department of Surgery
P.O. Box 1350
Eindhoven
5602 ZA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Catharina Hospital Eindhoven (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary