Efficacy of warm humidified insufflation for reducing post-operative ileus in patients undergoing acute general surgical laparotomy: A randomised single-blind controlled trial.

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 226

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:
oThe stomach, small or large bowel, or rectum for perforation, ischaemia, abdominal abscess, bleeding, obstruction, or trauma
oWashout/evacuation of intra-peritoneal abscess;
oWashout/evacuation of intra-peritoneal haematoma;
oBowel resection/repair due to incarcerated incisional, umbilical, inguinal, and femoral hernias (but not hernia repair without bowel resection/repair);
oBowel resection/repair due to obstructing/incarcerated incisional hernias if the presentation and findings were acute (including large incisional hernia repair with division of adhesions);
oInoperable pathology (e.g. peritoneal/hepatic metastases), not including purely diagnostic procedures;
oPathology caused by blunt or penetrating trauma;
oPathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract;
oReturn to theatre for repair of substantial dehiscence of major abdominal wound;
oAny 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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