A Randomized Controlled Trial Evaluating the Requirement for Post-operative Packing of Perianal Abscesses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Imperial College London
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Time to abscess healing
Study Overview
Brief Summary
TITLE Perianal Abscess Packing (PAP): a randomised controlled trial (Pilot study)
DESIGN Randomised controlled trial.
HYPOTHESIS In patients with perianal abscesses incision and drainage without packing the subsequent cavity will reduce patient discomfort without increasing healing time or recurrence compared with management involving cavity packing.
OUTCOME MEASURES
- Length of hospital stay
- Time to cavity healing
- Recurrent abscess or fistula formation
- Pain score
- Analgesia usage POPULATION All patients older than 18 years presenting with a perianal abscess.
ELIGIBILITY Exclusion criteria:
- under 18 years
- those unable to give informed consent
- abscesses associated with Crohn's disease or other underlying causes
- abscesses in which initial drainage is considered inadequate (if the skin is not open sufficiently to allow drainage of the abscess cavity)
DURATION Until recruitment of subjects is complete
Detailed Description
- INTRODUCTION
1.1 BACKGROUND
Perianal abscesses are common with an incidence of 0.5-1%. Some present as emergencies and all require surgery, placing a significant burden on health resources.
The mainstay of management is incision and drainage. Traditionally the residual cavity is then packed. On discharge, the cavity packing requires frequent changing. This uses considerable community nursing resource. Perianal abscesses can alternatively be treated by primary closure or without packing the cavity. Benefits of treating without packing include greater patient comfort and acceptance and reduced nursing requirement. However treating without packing is not yet widely accepted, in the absence of sufficient evidence that it is as safe and effective. This study aims to address this issue.
1.2 RATIONALE FOR CURRENT STUDY
- Question: In patients with perianal abscesses, does incision and drainage without packing the subsequent cavity reduce patient discomfort without increasing healing time or recurrence compared with management involving cavity packing?
- Hypothesis: Perianal abscess can be managed without cavity packing, with no increase in healing time or recurrence.
- Note this was partly addressed by Tonkin et al (2004) but their study was underpowered. We intend to have a sufficiently powered study to definitively answer the question.
- STUDY OBJECTIVES
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18
- •Clinical diagnosis of perianal abscess.
Exclusion Criteria
- •Patients who are unable or unwilling to consent.
- •Known fistulae
- •Crohn's Disease
- •Immune-suppression or malignancy
- •Recurrent abscess (where initial drainage insufficient).
Arms & Interventions
Control group (Packing)
The perianal abscess cavity will continue to be packed after discharge until healing is complete
Intervention: Control group (Packing) (Procedure)
Intervention Group (Non-Packing)
The cavity will be allowed to heal by secondary intention without packing.
Intervention: Intervention Group (Non-Packing) (Procedure)
Outcomes
Primary Outcomes
Time to abscess healing
Time Frame: Two weeks post operative
When abscess cavity has re-epitheliased. Assessed at two weeks and then weekly until healing occurs. Followed up for one year to assess recurrence
Secondary Outcomes
No secondary outcomes reported