Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2017
INTERVENTION: Patients presenting acutely with a primary perianal abscess who require surgical incision and drainage are randomised 1:1 post‐operatively to either: Arm A) Packing: Participants in this group have their perianal abscess cavity internally packed as per normal practice. Arm B) Non‐packing: Participants in this group have a pack placed in theatre as per normal practice, at dressing change the pack is removed and an external application of dressings applied to their perianal abscess cavity. All patients complete a baseline health related quality of life (HRQOL) questionnaire, followed by daily pain diaries and HRQOL questionnaires until day 10, then again on days 14 and 21. Return to work is established via telephone interviews at seven, 14 and 21 days. All participants undergo clinical assessment of healing, fistula‐in‐ano and abscess recurrence at four, eight (if not already healed at week four) and 26 weeks. Chronic pain is assessed at four, eight and 26 weeks. Clinical follow‐up ceases at week 26. Hospital admissions for fistula‐in‐ano and perianal abscess recurrences str obtained from central, NHS registries from weeks 26 to 52. Participants’ hospital records are accessed from the start of the study until six months after the study ends in order to capture information on any further wound‐related input from healthcare services outside of the original hospital admission. CONDITION: Specialty: Surgery, Primary sub‐specialty: Other; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of intestines ; Digestive System ; Oral and Gastrointestinal PRIMARY OUTCOME: Wound‐related pain (worst pain during previous 24 hours) is measured using patient reported 100mm Visual Analogue Score (VAS) where 0 represents “no pain” and 100 represents “worst pain possible” over the first 10 post‐operative days. SECONDARY OUTCOME: 1. Pain at dressing change is assessed using a 100mm VAS at days 1‐10, day 14 and day 21; 2. Health related quality of life are measured using the EQ‐5D‐5L descriptive system at baseline, days 1‐5, and on day 7, 14 and 21 ; 3. Health utility is measured using the EQ‐5D‐5L descriptive system at baseline, days 1‐5, and on day 7, 14 and 21; 4. Patient satisfaction with wound management is measured using a five point Likert Scale on day 10; 5. Rate of wound healing (complete epithelialization) is measured via clinical examination at four and eight weeks; 6. Post‐operative fistula‐in‐ano measured via clinical examination at four, eight and 26 weeks and via hospital episode statistics between week 26 and week 52; 7. Abscesses recurrence (after healing) is measured via clinical examination at four, eight and 26 weeks and via hospital episode statistics between week 26 and week 52; 8. Bleeding requiring transfusion or return to theatre is measured via clinical examination until week 26; 9. Chronic post‐surgical pain is measured using the Brief Pain Inventory – short form at weeks 4, 8 and 26; 10. Resource use (including dressing, health professional contact time, hospital admission, time to return to work or normal function, analgesic use) is measured up to week 52 via telephone interviews, pain diaries, hospital episodes statistics; 11. Cost (applied to resource use data above); 12. Patient assessment of the method of pain control using the Patient Global Assessment of the method of pain control at days 1‐10, day 14 and day 21 INCLUSION CRITERIA: 1. Aged 18 years or over 2. Undergoing surgical incision and drainage of a primary perianal abscess
Epistemonikos ID: 8a123639db11bbe81f8a98036f0837b8c0ac46c3
First added on: Aug 23, 2024