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 |
| Protocol serial number | N0213168035 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Royal West Sussex NHS Trust (UK), NHS R&D Support Funding |
- 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 of protocol
Not provided at time of registration
Contact information
Mr NPJ Cripps
Scientific
Scientific
Royal West Sussex NHS Trust
St Richard's Hospital
Spitalfield Lane
Chichester
PO19 6SE
United Kingdom
| Phone | +44 01243 831593 |
|---|---|
| neil.cripps@rws-tr.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Healing rates of anal fissure at 4, 12 and 24 weeks post surgery. |
| Key secondary outcome measure(s) |
1. Pain on defecation as assessed by Visual analogue score for 10 days post surgery |
| Completion date | 06/04/2007 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 70 |
| Key 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 |
| Key exclusion criteria | 1. Concurrent peri-anal disease 2. Previous fissure surgery |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 06/04/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal West Sussex NHS Trust
Chichester
PO19 6SE
United Kingdom
PO19 6SE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
