Condition category
Circulatory System
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
28/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.catharina-ziekenhuis.nl/

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

Publication citations

Additional files

Editorial Notes