Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
19/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Katherine Brown

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0594142233

Study information

Scientific title

Randomised trial comparing needle drainage of perianal abscess under local anaesthetic to conventional treatment by incision and drainage under general anaesthetic

Acronym

Study hypothesis

Can perianal sepsis be treated on an outpatient basis by needle drainage and antibiotics?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Signs and Symptoms: Perianal sepsis

Intervention

Needle drainage or incision and drainage under general anaesthesia.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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 trial start date

24/02/2004

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with fluctuant perianal sepsis are recruited on presentation to Accident and Emergency

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Ongoing until 100 patients are accrued - 30 patients have currently been recruited as of August 2005.

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

United Kingdom

Trial participating centre

Luton & Dunstable Hospital NHS Trust
Luton
LU4 0DZ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Luton and Dunstable NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes