Surgery - emergency laparotomy Surgery
Conditions
Interventions
The trial treatment period will commence at the start of general anaesthesia and continue for 6 hours after the completion of surgery. Eligible patients will be randomised to receive either cardiac-ou
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age 50 years and over 2. Scheduled to undergo a surgical procedure which fulfils the criteria for entry into the National Emergency Laparotomy Audit (NELA), i.e. an expedited, urgent or emergency abdominal procedure on the gastrointestinal tract within the audit scope, including: 2.1. Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction 2.2. Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis) 2.3. Bowel resection/repair due to incarcerated umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair) 2.4. Return to theatre for repair of substantial dehiscence of major abdominal wound (i.e. ‘burst abdomen’) or after patients underwent non-elective gastro-intestinal surgery 3. Patient has an NHS number The term “emergency” laparotomy is defined in line with NELA and the National Confidential Enquiry into PeriOperative Deaths (NCEPOD) 2004, to encompass the following categories: “immediate” surgery (required within two hours of the decision to operate), “urgent” surgery (required within 2-18 hours of the decision to operate) and “expedited” surgery (required within 18-24 hours of the decision to operate)
Exclusion criteria
Exclusion criteria: 1. Refusal of patient consent 2. Clinician refusal 3. Previous enrolment in the FLO-ELA trial 4. Previous inclusion in NELA within the current hospital admission 5. Current participation in another clinical trial of a treatment with a similar biological mechanism 6. Scheduled abdominal procedure outside the scope of NELA, including: elective procedures, uncomplicated appendicectomy or cholecystectomy, non-elective hernia repair without bowel resection, vascular surgery, including abdominal aortic aneurysm repair, Caesarean section, obstetric laparotomies or gynaecological laparotomy, or laparotomy/laparoscopy for pathology caused by trauma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 23/12/2021: Days Alive and Out of Hospital within 90 days of randomisation (DAOH-90) _____ Previous primary outcome measure: Mortality within 90 days of randomisation, using mortality data from NHS Digital/Office for National Statistics (or equivalents) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/11/2025: 1. Mortality within 90 days of randomisation 2. Mortality within 1 year of randomisation Measured using mortality data from NHS Digital/Office for National Statistics (or equivalents) Process outcomes: 1. Duration of hospital stay, from data entered into the National Emergency Laparotomy Audit (NELA) by teams in each participating hospital 2. Duration of stay in a critical care bed within the primary hospital admission, from data entered into NELA by teams in each participating hospital 3. Hospital readmission as an inpatient (overnight stay) within 90 days from randomisation, using data from NHS Digital/Hospital Episode Statistics (or equivalents) Health economic endpoints: 1. Mean cost of implementing the intervention and control treatments 2. Mean cost of secondary care resource use within 90 days from randomisation 3. Quality-adjusted life year gain at 90 days from randomisation using EQ-5D-3L-derived utility scores at baseline and 90 day follow-up (estimated from preceding EPOCH trial data – no EQ-5D-3L data collection will be required within the FLO-ELA trial) _____ Previous secondary outcome measures as of 23/12/2021: Mortality within 90 days of randomisation, using mortality data from NHS Digital/Office for National Statistics (or equivalents) Process outcomes: 1. Duration of hospital stay, from data entered into the National Emergency Laparotomy Audit (NELA) by teams in each participating hospital 2. Duration of stay in a critical care bed within the primary hospital admission, from data entered into NELA by teams in each participating hospital 3. Hospital readmission as an inpatient (overnight stay) within 90 days from randomisation, using data from NHS Digital/Hospital Episode Statistics (or equivalents) Health economic endpoints: 1. Mean cost of implementing the intervention and control treatments 2. Mean cost of secondary care resource use within 90 days from randomisation 3. Quality-adjusted | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactZoe Clark
Outcome results
None listed