Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084144553
Study information
Scientific title
Acronym
Study hypothesis
Does the completely closed and sutured technique of haemorrhoidectomy reduce discomfort and enhances healing in comparison to the standard open method?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Haemorrhoidectomy
Intervention
All patients diagnosed as having grade 3 or 4 haemorrhoids and require corrective surgery who fulfil the inclusion criteria seen in the general surgical outpatient department of Scunthorpe And Goole hospitals will be invited to take part in the study until the sample size has been achieved.
After patients have agreed to participate, they will be randomised into one or other of the treatment arms: 'standard open' haemorrhoidectomy vs 'completely closed and sutured' technique.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. A routine follow up clinical appointment will be sent to the patient at 4 weeks after surgery. Extent of healing will be scored on a scale from 1-4. (1:<25%; 2:25-50%; 3:50-75%; 4:complete healing).
2. Post operative SF 36 questionnaire at 4 weeks after surgery
3. Duration in days taken to return to normal daily activities
4. Percent satisfaction after the procedure
5. Consent to undergo the procedure again if required
Secondary outcome measures
Not provided at time of registration
Overall trial start date
02/01/2002
Overall trial end date
02/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
With reference to previously published studies, comparing open versus stapled techniques a similar sample size n=20 in each arm was arrived at.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
02/01/2002
Recruitment end date
02/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding
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