A prospective randomised study comparing 'standard open' haemorrhoidectomy with the 'completely closed and sutured' technique.

ISRCTN	ISRCTN52491619
DOI	https://doi.org/10.1186/ISRCTN52491619
Secondary identifying numbers	N0084144553

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 11/04/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Muzaffar Ahmad
Scientific

Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	Does the completely closed and sutured technique of haemorrhoidectomy reduce discomfort and enhances healing in comparison to the standard open method?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	02/01/2002
Completion date	02/01/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	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.
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	02/01/2002
Date of final enrolment	02/01/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Northern Lincolnshire & Goole Hospitals NHS Trust

Scunthorpe
DN15 7BH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan