A prospective randomised study comparing lateral internal sphincterotomy with anal dilatation in the treatment of anal fissures.
| ISRCTN | ISRCTN40397527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40397527 |
| Secondary identifying numbers | N0084144571 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 25/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 Muzaffar Ahmad
Scientific
Scientific
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom
Study information
| Study design | Prospective randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study hypothesis | Are Lateral Internal Sphincterotomy (LIS) and Anal Dilatation for the treatment of anal fissures both acceptable procedures giving equal results? |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Surgery: Anal fissure |
| Intervention | Patients diagnosed as having anal fissure who have been advised to have surgery for the same, and who have agreed to such advice and fulfil the inclusion criteria will be invited to take part in the study until sample size is achieved. Lateral internal sphincterotomy vs anal dilatation |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. The patient will be required to record all intake of Tramadol on the data collection sheet. The usage of as required medication would be used to calculate the difference in analgesic requirement between the two groups. 2. Anal incontinence will be assessed by the New St. Marks Score, extent of healing will be scored on a scale from 1 to 3, 1=no healing, 3=complete healing. 3. Pain scores on a numerical rating scale 0-10 will be collected from the patient as notes on day 1, day 5 and day 10. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 02/06/2003 |
| Overall study end date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | The aim of this study is to recruit 30 patients in each group to allow for patients lost to follow up and for patients who withdraw from the trial. |
| Participant inclusion criteria | Not provided at time of registration |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 02/06/2003 |
| Recruitment end date | 30/06/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom
DN15 7BH
United Kingdom
Sponsor information
Department of Health
Government
Government
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
Government
Northern Lincolnshire and Goole Hospitals 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 |
