|
ISRCTN
|
ISRCTN31631159
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Randomised trial comparing needle drainage of perianal abscess under local anaesthetic to conventional treatment by incision and drainage under general anaesthetic
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0594142233
|
|
Study hypothesis
|
Can perianal sepsis be treated on an outpatient basis by needle drainage and antibiotics?
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Signs and Symptoms: Perianal sepsis
|
|
Participants - inclusion criteria
|
Patients with fluctuant perianal sepsis are recruited on presentation to Accident and Emergency. After the trial is explained, the information leaflet given and consent taken the patients are randomised 2:1 to needle drainage or incision and drainage under general anaesthesia.
|
|
Participants - 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)
|
|
Anticipated start date
|
24/02/2004
|
|
Anticipated end date
|
31/05/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Ongoing until 100 patients are accrued - 30 patients have currently been recruited as of August 2005.
|
|
Interventions
|
Needle drainage or incision and drainage under general anaesthesia.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Luton and Dunstable NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Miss
Katherine
Brown
|
|
Address
|
Consultant Colorectal Surgeon
Luton & Dunstable Hospital NHS Trust
Lewsey Road
|
|
City/town
|
Luton
|
|
Zip/Postcode
|
LU4 0DZ
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2005
|
|
Last edited
|
10/06/2009
|
|
Date ISRCTN assigned
|
30/09/2005
|
