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
Protocol serial number	N0594142233
Sponsor	Department of Health
Funder	Luton and Dunstable NHS Trust (UK)

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

Miss Katherine Brown
Scientific

Consultant Colorectal Surgeon
Luton & Dunstable Hospital NHS Trust
Lewsey Road
Luton
LU4 0DZ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	Can perianal sepsis be treated on an outpatient basis by needle drainage and antibiotics?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Perianal sepsis
Intervention	Needle drainage or incision and drainage under general anaesthesia.
Intervention type	Procedure/Surgery
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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/05/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	Patients with fluctuant perianal sepsis are recruited on presentation to Accident and Emergency
Key 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)
Date of first enrolment	24/02/2004
Date of final enrolment	31/05/2006

Luton & Dunstable Hospital NHS Trust

Luton
LU4 0DZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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