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:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02226302
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80 years
* Any patient having abdominal surgery (Laparoscopic or open technique) for benign conditions
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients must have adequate:
* Hematologic function: Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L
* Renal function: serum creatinine ≤ ULN or estimated glomerular filtration rate (eGFR) \[CKD-EPI Formula\] ≥ 60 mL/min
* Hepatic function: serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN
* Physically able to undergo surgery
* Written informed consent
Exclusion Criteria:
* Confirmed gynaecological malignancy
* Contraindications and/or unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patients who are pregnant or lactating
* Serious illness or medical condition but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (patients with stable AF are eligible), or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with disseminated intra-peritoneal malignancy or suspected ovarian cancer
* HIV positive
* Previous bariatric surgery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02226302
Study Brief:
Protocol Section:
NCT02226302