Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT04192435
Eligibility Criteria:
Inclusion Criteria:
1\. Adult patients scheduled for elective or semi-elective (inpatient) open or lap-assisted GI surgery (oesophageal, gastric, hepatobiliary, colorectal) with one or more risk factors for complications:
* Age ≥70 years
* ASA physical status 3 or 4
* Known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease
* Obesity (BMI ≥30 kg/m2)
* Anaemia (preoperative haemoglobin \<130 g/l in males and \<120 g/l in females)
* Renal impairment (se. creatinine ≥150mol/l)
* Low albumin (\<30 g/L)
Exclusion Criteria:
* Poor spoken and or written language comprehension
* Laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery
* Pre-existing infection/sepsis
* Known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04192435
Study Brief:
Protocol Section:
NCT04192435