Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
06/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr NPJ Cripps

ORCID ID

Contact details

Royal West Sussex NHS Trust
St Richard's Hospital
Spitalfield Lane
Chichester
PO19 6SE
United Kingdom
+44 01243 831593
neil.cripps@rws-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0213168035

Study information

Scientific title

Acronym

Study hypothesis

To determine whether fissurectomy and botox injection or island advancement flap is superior in the surgical management of chronic anal fissure.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Fissurectomy

Intervention

Anal fissure is a painful type of ulcer around the anal canal. It often does not respond to topical therapy and surgery has to be considered. Current treatment has a risk of incontinence after surgery. We wish to look at two different kinds of surgery which do not have any risk of disturbing continence, and decide which is superior in managing anal fissure. The first is surgical removal of the fissure together with an injection of botox. The second is surgical removal of the fissure with a flap of skin to cover the wound. Both techniques avoid cutting of the 'sphincter' and so do not disturb continence.

Added 28 August 2008: trial stopped due to poor recruitment.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Healing rates of anal fissure at 4, 12 and 24 weeks post surgery.

Secondary outcome measures

1. Pain on defecation as assessed by Visual analogue score for 10 days post surgery
2. Patient's general health as assessed by SF-12 questionnaire at 24 weeks
3. Continence at 4, 12 and 24 weeks post surgery as assessed by the Cleveland incontinence score

Overall trial start date

01/08/2005

Overall trial end date

06/04/2007

Reason abandoned

Poor recruitment

Eligibility

Participant inclusion criteria

1. Chronic anal fissure resistant to 6 weeks GTN therapy
2. Features of fissure chronicity (skin tag, induration)
3. Suitable for day case surgery

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

35 patients in each arm.

Participant exclusion criteria

1. Concurrent peri-anal disease
2. Previous fissure surgery

Recruitment start date

01/08/2005

Recruitment end date

06/04/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal West Sussex NHS Trust
Chichester
PO19 6SE
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 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

Government

Funder name

Royal West Sussex 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