Randomised trial comparing needle drainage of perianal abscess under local anaesthetic to conventional treatment by incision and drainage under general anaesthetic
| ISRCTN | ISRCTN31631159 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31631159 |
| Secondary identifying numbers | N0594142233 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 19/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Miss Katherine Brown
Scientific
Scientific
Consultant Colorectal Surgeon
Luton & Dunstable Hospital NHS Trust
Lewsey Road
Luton
LU4 0DZ
United Kingdom
Study information
| Study design | Randomised controlled 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 below to request a patient information sheet |
| Scientific title | Randomised trial comparing needle drainage of perianal abscess under local anaesthetic to conventional treatment by incision and drainage under general anaesthetic |
| Study hypothesis | Can perianal sepsis be treated on an outpatient basis by needle drainage and antibiotics? |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Signs and Symptoms: Perianal sepsis |
| Intervention | Needle drainage or incision and drainage under general anaesthesia. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Failure of aspiration: the number of patients in this group requiring I&D subsequent to aspirations 2. Number of aspirations required Number of patients requiring EUA for fistula Patient acceptability |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 24/02/2004 |
| Overall study end date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Ongoing until 100 patients are accrued - 30 patients have currently been recruited as of August 2005. |
| Participant inclusion criteria | Patients with fluctuant perianal sepsis are recruited on presentation to Accident and Emergency |
| Participant exclusion criteria | 1. Diabetic patients 2. Patients under 16 3. Pregnant patients 4. Patients who are immunosuppressed 5. Patients with an obvious perianal fistula 6. Patients in whom other pathology is suspected (e.g. anal cancer) |
| Recruitment start date | 24/02/2004 |
| Recruitment end date | 31/05/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Luton & Dunstable Hospital NHS Trust
Luton
LU4 0DZ
United Kingdom
LU4 0DZ
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
Luton and Dunstable 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 |
