A prospective randomised study comparing lateral internal sphincterotomy with anal dilatation in the treatment of anal fissures.

ISRCTN	ISRCTN40397527
DOI	https://doi.org/10.1186/ISRCTN40397527
Protocol serial number	N0084144571
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	Prospective randomised study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Are Lateral Internal Sphincterotomy (LIS) and Anal Dilatation for the treatment of anal fissures both acceptable procedures giving equal results?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anal fissure
Intervention	Patients diagnosed as having anal fissure who have been advised to have surgery for the same, and who have agreed to such advice and fulfil the inclusion criteria will be invited to take part in the study until sample size is achieved. Lateral internal sphincterotomy vs anal dilatation
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. The patient will be required to record all intake of Tramadol on the data collection sheet. The usage of as required medication would be used to calculate the difference in analgesic requirement between the two groups. 2. Anal incontinence will be assessed by the New St. Marks Score, extent of healing will be scored on a scale from 1 to 3, 1=no healing, 3=complete healing. 3. Pain scores on a numerical rating scale 0-10 will be collected from the patient as notes on day 1, day 5 and day 10.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	02/06/2003
Date of final enrolment	30/06/2004

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