None listed
Conditions
Brief summary
The overall aim of this randomised, controlled, single-blind trial is to investigate the impact of warm humidified insufflation on post-operative ileus in patients undergoing acute general surgical laparotomy. We hypthesise that warm humidified insufflation during surgery will reduce the length of post-operative ileus as defined by clinical markers of return to bowel function, improved gut dysfunction, and improved quality of life.
Interventions
All patients will receive standardised anaesthesia, warming, and pain relief throughout the operation. If participants are randomsied to the intervention arm, the intervention device (F&P HumiGard™ system) will be set up during patient preparation as per device user instructions. HumiGard delivers dry medical CO2 at a flow rate of 10 L/min from a medical CO2 cylinder. The temperature at which CO2 is delivered is at 32.1 degree celcius.
The diffuser will be placed in the abdominal cavity by the
All patients will receive standardised anaesthesia, warming, and pain relief throughout the operation. If participants are randomsied to the intervention arm, the intervention device (F&P HumiGard™ system) will be set up during patient preparation as per device user instructions. HumiGard delivers dry medical CO2 at a flow rate of 10 L/min from a medical CO2 cylinder. The temperature at which CO2 is delivered is at 32.1 degree celcius. The diffuser will be placed in the abdominal cavity by the operating surgeon. For all participants, a 5-6mm four tissue punch biopsies will be taken by the surgeon directly after incision, at 1 hour and as soon as the retractors are removed for closure. If the procedure is longer than 2 hours, additional four 5-6mm tissue punch biopsies will be taken at 2 hours post-incision as well. The peritoneal biopsy sites will be ideally chosen in healthy peritoneal areas at the discretion of the operating surgeon. The site of biopsies will be recorded by the research nurse. The presence of macro or microscopic disease on the peritoneum may affect the markers of inflammation measured by QRT-PCR or equivalent. The peritoneum is opened to allow access for the surgical procedure. The tissues punches are from internal tissue and will have no aesthetic impact on the patient.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients aged at least 18 years; • Able to give informed consent and understand risks and benefits of the study; • Patients undergoing an elective, expedited, urgent, or emergency laparotomy lasting at least 60 minutes; • Laparotomy involving: o The stomach, small or large bowel, or rectum for perforation, ischaemia, abdominal abscess, bleeding, obstruction, or trauma o Washout/evacuation of intra-peritoneal abscess; o Washout/evacuation of intra-peritoneal haematoma; o Bowel resection/repair due to incarcerated incisional, umbilical, inguinal, and femoral hernias (but not hernia repair without bowel resection/repair); o Bowel resection/repair due to obstructing/incarcerated incisional hernias if the presentation and findings were acute (including large incisional hernia repair with division of adhesions); o Inoperable pathology (e.g. peritoneal/hepatic metastases), not including purely diagnostic procedures; o Pathology caused by blunt or penetrating trauma; o Pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract; o Return to theatre for repair of substantial dehiscence of major abdominal wound; o Any reoperation/return to theatre for complications of elective general/upper GI surgery meeting the above criteria; • Re-look laparotomies.
Exclusion criteria
• Active inflammatory bowel disease • Moderate to severe renal impairment (eGFR<50mL/min/1.73m2) • Severe hepatic impairment (Child-Pugh C) • Pregnancy • All other gynae and obstetrics patients • Pre-existing gut motility disorder including endocrine, metabolic or neurological cause • Pre-operative malnutrition requiring parenteral nutrition • Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment, language difficulties, delirium • Diagnostic laparotomy • Appendicectomy • Cholecystectomy • Hernia repair without bowel resection or division of adhesions • Minor abdominal wound dehiscence • Laparoscopic procedures • Vascular surgery • Sclerosing peritonitis • Removal of dialysis catheters • Oesophageal pathology
Outcome results
None listed