A clinical trial of blood flow optimisation for patients who have emergency bowel surgery

Not Applicable

• Conditions: Surgery - emergency laparotomy; Surgery

• Registration Number: ISRCTN14729158
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

2023 Protocol article in https://doi.org/10.1186/s13063-023-07275-3 (added 09/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-02
• Last Update Posted: 8 January 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3138

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 23/12/2021: <br><br>Days Alive and Out of Hospital within 90 days of randomisation (DAOH-90)<br><br>_____<br><br>Previous primary outcome measure:<br><br>Mortality within 90 days of randomisation, using mortality data from NHS Digital/Office for National Statistics (or equivalents)