Perianal Abscess Clinical Trial
Official title:
The Impact of Postoperative Packing of Perianal Abscess Cavities: a Multicentre Randomised Controlled Trial
The aim of this trial is to compare internal wound packing to no packing in postoperative management following incision and drainage of perianal abscess. Participants will be randomised 1:1 to either the packing or non-packing arm.
Perianal abscess is common, affecting 18,000 patients annually in England. Management has
remained largely unchanged for over 50 years, and comprises surgical incision and drainage
followed by continued internal wound dressing (packing) until healed. Packing is thought to
reduce the rate of recurrent abscess and perianal fistula; a known complication of perianal
abscess. Perianal fistula frequently requires multiple operations to resolve. The evidence
for postoperative packing is limited¹ and may expose patients to painful procedures with no
clinical benefit, and at considerable increased cost².
A multi-centre observational study of outcomes after drainage of perianal abscess (PPAC²)
(n=141) found packing to be painful (2-3 fold increase in Visual Analogue Score pain scores
during packing) and costly (estimated cost of £280 per patient; overall cost in the United
Kingdom of £5 million annually). Fistula rate was 27%.
This study is a randomised controlled trial designed to assess whether there are differences
between non-packing and packing of the perianal abscess cavity in terms of the short term
negative effects of packing (pain, quality of life, return to work) whilst assessing the
impact on key clinical outcomes (wound healing, fistulae formation) and resource use/cost.
All participants will be required to complete pain diaries following discharge from hospital.
Clinical follow up to assess healing and other key clinical outcomes will take place at 4, 8
(if not healed at 4 weeks) and 26 weeks. Further data will be collected from National Health
Service Registries at 52 weeks in order to assess abscess recurrences and fistulae formation.
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|---|---|---|---|
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||
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