| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN58539902 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0051116137 |
| Public title | Randomised study comparing the effects of lateral anal sphincterotomy, glyceryl trinitrate and botulinium toxin in the management of chronic anal fissures |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Digestive System: Chronic annal fissure |
| 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. |
| Design/methodology | Double blind randomised trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 120 males and females aged 18-65 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/04/2002 |
| Anticipated end date | 31/03/2008 |
| Status of trial | Completed |
| Target number of participants | 120 |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Brighton and Sussex University Hospitals NHS Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Paul Farrands |
| Contact details | Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
United Kingdom
BN2 5BE |
| Contact telephone | +44 01273 696955 X 4647 |
| Contact fax | +44 |
| Contact email | paul.farrands@bsuh.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN58539902 |
| Date last extracted from ISRCTN register | 17/04/2008 |
