Clinical trial NCT03315169: Packing of Perianal Abscess Cavities
Official title: The Impact of Postoperative Packing of Perianal Abscess Cavities: a Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perianal Abscess
Perianal Infections
Peri Rectal Abscess
Abscess; Anus
Abscess Anorectal
Keywords: Incision and Drainage
Packing
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Liverpool
name: Northwest Research Collaborative
name: University of Birmingham
name: National Institute for Health Research, United Kingdom
First posted: 2017-10-20
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 or over
2. Undergoing surgical incision and drainage of a primary perianal abscess

Exclusion Criteria:

1. Suspected inflammatory bowel disease
2. Fournier's Gangrene
3. Horseshoe (bilateral) abscess
4. Fistula-in-ano
5. Multiple abscess

Primary outcomes:
measure: Wound-related pain intensity
timeFrame: Mean score over first 10 post-operative days
Secondary outcomes:
measure: Dressing-change related pain intensity
timeFrame: First 10 post-operative days
measure: Health related quality of life
timeFrame: On the 21st post-operative day
measure: Health utility
timeFrame: On the 21st post-operative day
measure: Patient satisfaction with wound management
timeFrame: On the 21st post-operative day
measure: Rate of wound healing
timeFrame: Four and eight weeks post-operatively
measure: Clinical diagnosis of perianal abscesses recurrence after healing
timeFrame: 52 weeks post-operatively
measure: Chronic post-surgical pain
timeFrame: 4, 8 and 26 weeks post-operatively
measure: Dressing use
timeFrame: Up to 52 weeks post-operatively
measure: Health Professional contact time
timeFrame: Up to 52 weeks post-operatively
measure: Hospital admission time
timeFrame: Up to 52 weeks post-operatively
measure: Time to return to work or normal function
timeFrame: Up to 52 weeks post-operatively
measure: Cost
timeFrame: Up to 52 weeks post-operatively
measure: Assessment of pain control methods
timeFrame: 21 days post-operatively
measure: Fistula rate
timeFrame: Up ro 52 weeks post-operatively
Other outcomes:
Locations:
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
state: Greater Manchester
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital (Isleworth)
state: Middlesex
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
city: Wolverhampton
country: United Kingdom
facility: Mew Cross Hospital
state: West Midlands
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary
state: West Yorkshire
city: Wakefield
country: United Kingdom
facility: Pindersfields General Hospital
state: West Yorkshire
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
state: Wiltshire
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Bangor
country: United Kingdom
facility: Bangor Hospital, Betsi Cadwaladr University Health Board
city: Barrow In Furness
country: United Kingdom
facility: Furness General Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Bristol
country: United Kingdom
facility: Bristol royal Infirmary, University Hospitals Bristol
city: Bristol
country: United Kingdom
facility: Southmead Hospital North Bristo; NHS Trust
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales (Cardiff)
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospital NHS Foundation Trust
city: Chester
country: United Kingdom
facility: Countess of Chester
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
city: Kirkcaldy
country: United Kingdom
facility: Victoria Hospital (Fife)
city: Lancaster
country: United Kingdom
facility: Royal Lancaster Infirmary
city: Liverpool
country: United Kingdom
facility: Aintree Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen University Hospitals NHS Trust
city: Llantrisant
country: United Kingdom
facility: Royal Glamorgan Hospital
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Margate
country: United Kingdom
facility: Queen Elizabeth The Queen Mother Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle Upon Tyne University Hospitals NHS Foundation Trust
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Paisley
country: United Kingdom
facility: Royal Alexandra Hospital
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust Derriford Hospital
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Upton
country: United Kingdom
facility: Arrowe Park Hospital
city: Warrington
country: United Kingdom
facility: Warrington Hospital
city: Warwick
country: United Kingdom
facility: Warwick Hospital, South Warwickshire NHS Foundation Trust
city: West Bromwich
country: United Kingdom
facility: Sandwell Hospital, SWBH NHS Trust
city: Wigan
country: United Kingdom
facility: Royal Albert and Edward Infirmary
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: James Hill, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith SR, Newton K, Smith JA, Dumville JC, Iheozor-Ejiofor Z, Pearce LE, Barrow PJ, Hancock L, Hill J. Internal dressings for healing perianal abscess cavities. Cochrane Database Syst Rev. 2016 Aug 26;2016(8):CD011193. doi: 10.1002/14651858.CD011193.pub2.
citation: Pearce L, Newton K, Smith SR, Barrow P, Smith J, Hancock L, Kirwan CC, Hill J; North West Research Collaborative. Multicentre observational study of outcomes after drainage of acute perianal abscess. Br J Surg. 2016 Jul;103(8):1063-8. doi: 10.1002/bjs.10154. Epub 2016 Apr 7.
citation: Newton K, Dumville J, Briggs M, Law J, Martin J, Pearce L, Kirwan C, Pinkney T, Needham A, Jackson R, Winn S, McCulloch H, Hill J; PPAC2 Collaborators. Postoperative Packing of Perianal Abscess Cavities (PPAC2): randomized clinical trial. Br J Surg. 2022 Sep 9;109(10):951-957. doi: 10.1093/bjs/znac225.