Condition category
Digestive System
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
29/01/2015
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 Paul Farrands

ORCID ID

Contact details

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44 (0)1273 696955 X 4647
paul.farrands@bsuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0051116137

Study information

Scientific title

Randomised study comparing the effects of lateral anal sphincterotomy, glyceryl trinitrate and botulinium toxin in the management of chronic anal fissures

Acronym

Study hypothesis

To determine whether botulinium toxin is clinically and financially an effective out patient alternative to Glyceryl Trinitrate and lateral anal sphincterotomy treatment of chronic anal fissures.

Ethics approval

Not provided at time of registration

Study design

Double-blind randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Digestive System: Chronic anal fissure

Intervention

Double-blind randomised trial, incorporating clinical and laboratory examinations prior to application of the drug at one week and one, two, three and six months post application.

Intervention type

Drug

Phase

Not Applicable

Drug names

Glyceryl trinitrate, botulinium toxin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2002

Overall trial end date

31/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

120 males and females aged 18-65

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2002

Recruitment end date

31/03/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
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

Hospital/treatment centre

Funder name

Brighton and Sussex University Hospitals NHS Trust (UK)

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