Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised trial of stapled haemorrhoidopexy versus rubber band ligation in the treatment of circumferential symptomatic grade II haemorrhoids
Acronym
Study hypothesis
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.
Ethics approval
Ethics approval received from the Grampian Research Ethics Committee on the 11th August 2002 (ref: 01/0297).
Study design
Single centre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Circumferential grade II symptomatic haemorrhoids
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Disease recurrence at six weeks and one year.
Secondary outcome measures
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.
Overall trial start date
20/10/2002
Overall trial end date
02/04/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Circumferential grade II symptomatic haemorrhoids irrespective of age and gender.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Associated anaorctal sepsis
2. Associated colonic malignancy or inflammatory bowel disease
3. Associated anal sphincter pathology
Recruitment start date
20/10/2002
Recruitment end date
02/04/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ward 50
Aberdeen
AB25 2ZN
United Kingdom
Sponsor information
Organisation
Medicines Assessment Research Unit (MARU) (UK)
Sponsor details
c/o Mr MA Loudon and Mr AJM Watson
Grampian Hospitals NHS Trust
Aberdeen Royal Infirmary
Ward 50
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Ethicon Endo-Surgery (Europe) GmbH (Germany)
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19508532
Publication citations
-
Results
McKenzie L, de Verteuil R, Cook J, Shanmugam V, Loudon M, Watson AJ, Vale L, Economic evaluation of the treatment of grade II haemorrhoids: a comparison of stapled haemorrhoidopexy and rubber band ligation., Colorectal Dis, 2010, 12, 6, 587-593, doi: 10.1111/j.1463-1318.2009.01889.x.