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 |
| Protocol serial number | N0051116137 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Brighton and Sussex University Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Glyceryl trinitrate, botulinium toxin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
BN2 5BE
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/06/2017: No publications found, verifying study status with principal investigator.
