Packing of Perianal Abscess Cavities
- Conditions
- Perianal InfectionsAbscess; AnusPeri Rectal AbscessAbscess AnorectalPerianal Abscess
- Interventions
- Other: External dressingOther: Packing of perianal abscess cavity
- Registration Number
- NCT03315169
- Lead Sponsor
- Manchester University NHS Foundation Trust
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 433
- Aged 18 or over
- Undergoing surgical incision and drainage of a primary perianal abscess
- Suspected inflammatory bowel disease
- Fournier's Gangrene
- Horseshoe (bilateral) abscess
- Fistula-in-ano
- Multiple abscess
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description External dressing External dressing External application of a non-adherent dressing to the perianal abscess cavity. Packing of perianal abscess cavity Packing of perianal abscess cavity Internal packing of perianal abscess cavity as per normal practice.
- Primary Outcome Measures
Name Time Method Wound-related pain intensity Mean score over first 10 post-operative days Wound-related pain intensity (worst pain during previous 24 hours) measured using a single 100mm Visual Analogue Scale where 0 represents 'no pain' and 100 represents 'worst pain possible'. The pain Visual Analogue Scale is a continuous scale comprised of a horizontal line 100mm in length, anchored by 2 verbal descriptors, one for each symptom extreme, where 0 represents 'no pain' and 100 represents 'worst pain possible'. The mean score over the first 10 post-operative days will be used.
- Secondary Outcome Measures
Name Time Method Clinical diagnosis of perianal abscesses recurrence after healing 52 weeks post-operatively Clinical diagnosis of perianal abscesses recurrence after healing, ascertained either through clinical follow-up as part of trial procedures or via central National Health Service registries.
Time to return to work or normal function Up to 52 weeks post-operatively Length of time, measured in days, between operation and return to work or normal function.
Rate of wound healing Four and eight weeks post-operatively Rate of wound healing (complete epithelialization)
Patient satisfaction with wound management On the 21st post-operative day Patient satisfaction with wound management measured using a five point Likert scale. Patients are asked to mark the extent to which they agree with the statement 'I am satisfied with the way my wound has been treated following my surgery' where 1 equates to 'strongly disagree' and 5 equates to 'strongly agree'.
Dressing use Up to 52 weeks post-operatively Number of dressings used between time of operation up until week 52.
Health related quality of life On the 21st post-operative day Health related quality of life measured using EuroQol EQ-5D-5L quality of life questionnaires. The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.
Health utility On the 21st post-operative day Health utility measured using EuroQol EQ-5D-5L quality of life questionnaires. The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.
Chronic post-surgical pain 4, 8 and 26 weeks post-operatively Chronic post-surgical pain measured using the Brief Pain Inventory - Short Form. The Brief Pain Inventory - Short Form assesses the severity of pain and the impact on daily functions. Pain is assessed at its "worst," "least," "average," and "now" (current pain), measured on a scale of 1-10 where 1 represents "no pain" and 10 represents "pain as bad as you can imagine". The four items will be represented singly but a composite of the four pain items (a mean score) will be presented as supplemental information. Pain interference (impact of pain on seven daily activities) will be scored as the mean of the seven interference items. These items are scored between 1 and 10, where 1 represents "does not interfere" and 10 represents "completely interferes".
Hospital admission time Up to 52 weeks post-operatively Number and length of hospital admissions as recorded in NHS central registries - Hospital Episodes Statistics.
Dressing-change related pain intensity First 10 post-operative days Pain before, during and after dressing change measured using a 100mm Visual Analogue Scale where 0 represents 'no pain' and 100 represents 'worst pain possible'. The pain Visual Analogue Scale is a continuous scale comprised of a horizontal line 100 mm in length, anchored by 2 verbal descriptors, one for each symptom extreme. The mean score for each timepoint (before, during and after) over the first 10 post-operative days will be used.
Health Professional contact time Up to 52 weeks post-operatively Number of contacts with a Health Professional regarding perianal abscess or post-surgical complications between time of operation and 52 weeks post-operatively.
Cost Up to 52 weeks post-operatively Cost as applied to resource use data (see outcome 9-12)
Assessment of pain control methods 21 days post-operatively Assessment of pain control methods (i.e. pain control medications) using Patient Global Assessment of the method of pain control where a rating of the pain control method over the past 24 hours is rated as being one of "poor," "fair," "good," or "excellent".
Fistula rate Up ro 52 weeks post-operatively Fistula rate observed during clinical follow up and through Hospital Episodes Statistics
Trial Locations
- Locations (50)
Mew Cross Hospital
🇬🇧Wolverhampton, West Midlands, United Kingdom
Salford Royal Hospital
🇬🇧Salford, Greater Manchester, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, Wiltshire, United Kingdom
West Middlesex University Hospital (Isleworth)
🇬🇧Isleworth, Middlesex, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorkshire, United Kingdom
Royal United Hospital Bath NHS Foundation Trust
🇬🇧Bath, United Kingdom
Queen Elizabeth Hospital Birmingham
🇬🇧Birmingham, United Kingdom
Royal Bolton Hospital
🇬🇧Bolton, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Royal Blackburn Hospital
🇬🇧Blackburn, United Kingdom
Bristol royal Infirmary, University Hospitals Bristol
🇬🇧Bristol, United Kingdom
Southmead Hospital North Bristo; NHS Trust
🇬🇧Bristol, United Kingdom
University Hospital of Wales (Cardiff)
🇬🇧Cardiff, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Chesterfield Royal Hospital NHS Foundation Trust
🇬🇧Chesterfield, United Kingdom
Victoria Hospital (Fife)
🇬🇧Kirkcaldy, United Kingdom
University Hospitals Coventry and Warwickshire
🇬🇧Coventry, United Kingdom
Royal Devon & Exeter Hospital
🇬🇧Exeter, United Kingdom
Royal Lancaster Infirmary
🇬🇧Lancaster, United Kingdom
Aintree Hospital
🇬🇧Liverpool, United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
🇬🇧Liverpool, United Kingdom
Royal Glamorgan Hospital
🇬🇧Llantrisant, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Macclesfield District General Hospital
🇬🇧Macclesfield, United Kingdom
Newcastle Upon Tyne University Hospitals NHS Foundation Trust
🇬🇧Newcastle, United Kingdom
Queen Elizabeth The Queen Mother Hospital
🇬🇧Margate, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Royal Gwent Hospital
🇬🇧Newport, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Royal Alexandra Hospital
🇬🇧Paisley, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Plymouth Hospitals NHS Trust Derriford Hospital
🇬🇧Plymouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Warrington Hospital
🇬🇧Warrington, United Kingdom
Arrowe Park Hospital
🇬🇧Upton, United Kingdom
Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board
🇬🇧Wrexham, United Kingdom
Sandwell Hospital, SWBH NHS Trust
🇬🇧West Bromwich, United Kingdom
Royal Albert and Edward Infirmary
🇬🇧Wigan, United Kingdom
Warwick Hospital, South Warwickshire NHS Foundation Trust
🇬🇧Warwick, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
Portsmouth Hospitals NHS Trust
🇬🇧Portsmouth, United Kingdom
Pindersfields General Hospital
🇬🇧Wakefield, West Yorkshire, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Bangor Hospital, Betsi Cadwaladr University Health Board
🇬🇧Bangor, United Kingdom
Furness General Hospital
🇬🇧Barrow In Furness, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Broomfield Hospital
🇬🇧Chelmsford, United Kingdom
Countess of Chester
🇬🇧Chester, United Kingdom