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

ISRCTN	ISRCTN52491619
DOI	https://doi.org/10.1186/ISRCTN52491619
Protocol serial number	N0084144553
Sponsor	Department of Health
Funder	Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding

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

Mr Muzaffar Ahmad
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	02/01/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	40
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

Northern Lincolnshire & Goole Hospitals NHS Trust

Scunthorpe
DN15 7BH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan