Topic: Oral and Gastrointestinal
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 16 years and over, either sex 2. Presenting at Aberdeen Royal Infirmary (ARI) 3. Diagnosed with acute appendicitis and for whom laparoscopic surgical management is judged appropriate
Exclusion criteria
Exclusion criteria: 1. Patients who have had previous open abdominal surgery through midline incision 2. Patients who have had previous umbilical hernia repair with mesh 3. Patients unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain Numerical Rating Scale at days 1 to 7 post surgery 2. Body Image Questionnaire at 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient reported measures: Hospital Experience Questionnaire (HEQ) measured at 6 weeks; analgesic usage peri-operatively, Days 1-7 (diary) and at 6 weeks and time to return to normal activities at 6 weeks after surgery. 2. Clinical outcomes: Analgesic use; duration of operation (minutes) and complication rates; conversion rates peri-operatively ; infection rates (intra-abdominal and wound) peri-operatively and at 6 weeks; hospital re-admission rates at 6 weeks after surgery; reoperation rates and port-site hernia at 6 weeks after surgery. 3. Feasibility measures: Eligible patients per month; proportion formally considered for trial entry; proportion randomised (and reasons why not); proportion who are unaware of their received intervention at 24 hours; proportion of those recruited with complete data set at 6 weeks; surgeon?s perception of SPILS approach and the suitability of available equipment peri-operatively. | — |
Countries
United Kingdom