Elective surgery for intra-abdominal cancer Surgery Elective surgery for intra-abdominal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults 18 years or over undergoing elective surgery for intra-abdominal cancer (colorectal, pancreatic or gynaecological) under general anaesthesia, and at increased risk of postoperative complications, as defined by the American College of Surgeons National Surgical Quality Improvement Project (ACS NSQIP) calculated risk of morbidity >10%
Exclusion criteria
Exclusion criteria: 1. Patients unable to give consent 2. Day surgery 3. Emergency surgery 4. Total intravenous anaesthesia 5. Pregnancy 6. Recent (< 1 month) or ongoing acute myocardial infarction 7. Unstable or ongoing angina 8. Peripheral vascular disease 9. History of vascular intervention in the limb to be used for RIPC 10. Thromboembolic disease 11. Significant coagulopathy or bleeding diathesis 12. Sickle cell disease 13. Neuromuscular diseases 14. Use of sulfonylureas or nicorandil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of substantive trial measured using the recruitment rate of 50 participants over 12 months. Feasibility assessment will include the proportion of potentially eligible patients that are recruited to the study and followed up at the specified timepoints (days 2, 3, 5 30, 90, 180) and the proportion of required blood and urine samples that are collected and analysed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postoperative morbidity (as defined by Postoperative Morbidity Survey or POMS on days 2, 3, and 5 and the American College of Surgeons National Safety Quality Improvement Program or ACS NSQIP within 30 days, 90 days and 6 months postoperatively). 2. High sensitivity Troponin pre-operatively and on the first postoperative day 3. Renal stress biomarkers (urinary TIMP-2 * IGFBP-7) measured at 4 hours postoperatively 4. Hospital length of stay 5. Quality of life measured using the EQ-5D-5L questionnaire 6. Acceptability of the study assessed at the out of hospital follow-up | — |
Countries
England, United Kingdom