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ISRCTN
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ISRCTN23585705
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial comparing two treatment methods for symptomatic haemorrhoidal disease
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Scientific title
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A randomised trial of stapled haemorrhoidopexy versus rubber band ligation in the treatment of circumferential symptomatic grade II haemorrhoids
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Treatment with stapled haemorrhoidopexy produces better symptom control and less recurrent disease compared to rubber band ligation; both are considered to treat the disease in a similar mechanism of fixing the haemorrhoidal cushion without excising them.
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Ethics approval
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Ethics approval received from the Grampian Research Ethics Committee on the 11th August 2002 (ref: 01/0297).
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Study design
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Single centre, randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Circumferential grade II symptomatic haemorrhoids
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Participants - inclusion criteria
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Circumferential grade II symptomatic haemorrhoids irrespective of age and gender.
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Participants - exclusion criteria
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1. Associated anaorctal sepsis
2. Associated colonic malignancy or inflammatory bowel disease
3. Associated anal sphincter pathology
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Anticipated start date
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20/10/2002
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Anticipated end date
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02/04/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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60
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Interventions
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1. Rubber band ligation
2. Stapled haemorrhoidopexy
Both arms are treated as a one-off to begin with and then reviewed at six weeks. As per the protocol, If there is a recurrence of disease, a repeat treatment can be given. The rubber band ligation can be repeated up to four times at six-week intervals, before being declared failure of treatment. Similarly, the stapled haemorrhoidopexy will be repeated up to two more times before declared as failure of treatment.
Total follow-up is up to one year including 6-week and 26-week follow-ups in between.
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Primary outcome measure(s)
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Disease recurrence at six weeks and one year.
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Secondary outcome measure(s)
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1. Symptom score (validated and published already)
2. Cleveland continence score
3. Quality of life score (36-item Short Form health survey [SF-36], EuroQoL instrument [EQ-5D] and Hospital Anxiety and Depression Scale [HAD] scores)
4. Cost effectiveness
5. Sphincter damage
All secondary outcomes were assessed at 6 weeks, 26 weeks and one year.
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Sources of funding
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Ethicon Endo-Surgery (Europe) GmbH (Germany)
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Trial website
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Publications
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Contact name
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Mr
Malcolm
Loudon
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Address
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Ward 50
Aberdeen Royal Infirmary
Foresterhill
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City/town
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Aberdeen
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Zip/Postcode
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AB25 2ZN
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Country
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United Kingdom
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Sponsor
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Medicines Assessment Research Unit (MARU) (UK)
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Address
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c/o Mr MA Loudon and Mr AJM Watson
Grampian Hospitals NHS Trust
Aberdeen Royal Infirmary
Ward 50
Foresterhill
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City/town
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Aberdeen
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Zip/Postcode
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AB25 2ZN
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Country
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United Kingdom
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Sponsor website:
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http://www.nhsgrampian.org
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Date applied
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05/05/2008
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Last edited
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23/06/2008
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Date ISRCTN assigned
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23/06/2008
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