Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
25/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Muzaffar Ahmad

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084144571

Study information

Scientific title

Acronym

Study hypothesis

Are Lateral Internal Sphincterotomy (LIS) and Anal Dilatation for the treatment of anal fissures both acceptable procedures giving equal results?

Ethics approval

Not provided at time of registration

Study design

Prospective randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/06/2003

Overall trial end date

30/06/2004

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

The aim of this study is to recruit 30 patients in each group to allow for patients lost to follow up and for patients who withdraw from the trial.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

02/06/2003

Recruitment end date

30/06/2004

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes