Randomised controlled trial of fissurectomy and botulinum toxin injection versus island flap in the management of chronic anal fissure

ISRCTN	ISRCTN55110272
DOI	https://doi.org/10.1186/ISRCTN55110272
Secondary identifying numbers	N0213168035

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 06/10/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Mr NPJ Cripps
Scientific

Royal West Sussex NHS Trust
St Richard's Hospital
Spitalfield Lane
Chichester
PO19 6SE
United Kingdom

Phone	+44 01243 831593
Email	neil.cripps@rws-tr.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
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(s)	Not provided at time of registration
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
Primary outcome measure	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 study start date	01/08/2005
Overall study end date	06/04/2007
Reason abandoned (if study stopped)	Poor recruitment

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	35 patients in each arm.
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 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

England
United Kingdom

Study participating centre

Royal West Sussex NHS Trust

Chichester
PO19 6SE
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal West Sussex NHS Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan