The Impact of Postoperative Packing of Perianal Abscess Cavities: a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 433
- 试验地点
- 58
- 主要终点
- Wound-related pain intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Note that only the clinician assessing healing and fistulae are masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or over
- •Undergoing surgical incision and drainage of a primary perianal abscess
排除标准
- •Suspected inflammatory bowel disease
- •Fournier's Gangrene
- •Horseshoe (bilateral) abscess
- •Fistula-in-ano
- •Multiple abscess
结局指标
主要结局
Wound-related pain intensity
时间窗: 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.
次要结局
- Clinical diagnosis of perianal abscesses recurrence after healing(52 weeks post-operatively)
- Time to return to work or normal function(Up to 52 weeks post-operatively)
- Rate of wound healing(Four and eight weeks post-operatively)
- Dressing use(Up to 52 weeks post-operatively)
- Patient satisfaction with wound management(On the 21st post-operative day)
- Health related quality of life(On the 21st post-operative day)
- Health utility(On the 21st post-operative day)
- Chronic post-surgical pain(4, 8 and 26 weeks post-operatively)
- Hospital admission time(Up to 52 weeks post-operatively)
- Dressing-change related pain intensity(First 10 post-operative days)
- Health Professional contact time(Up to 52 weeks post-operatively)
- Cost(Up to 52 weeks post-operatively)
- Assessment of pain control methods(21 days post-operatively)
- Fistula rate(Up ro 52 weeks post-operatively)