Randomised study comparing the effects of lateral anal sphincterotomy, glyceryl trinitrate and botulinium toxin in the management of chronic anal fissures
| ISRCTN | ISRCTN58539902 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58539902 |
| Secondary identifying numbers | N0051116137 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 07/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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 Paul Farrands
Scientific
Scientific
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
| Phone | +44 (0)1273 696955 X 4647 |
|---|---|
| paul.farrands@bsuh.nhs.uk |
Study information
| Study design | Double-blind randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised study comparing the effects of lateral anal sphincterotomy, glyceryl trinitrate and botulinium toxin in the management of chronic anal fissures |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Glyceryl trinitrate, botulinium toxin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2002 |
| Completion date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 120 males and females aged 18-65 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 31/03/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
Brighton and Sussex University Hospitals NHS Trust (UK)
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 |
Editorial Notes
07/06/2017: No publications found, verifying study status with principal investigator.
