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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT06175169
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for broad eligibility were applied to reflect that the CT utilization rate in the emergency room has rapidly expanded, presumably in many other institutions where physicians maintain a reasonably sensitive standpoint in raising a clinical suspicion of appendicitis as a cause of abdominal pain and then use CT as an imaging test to confirm or rule out appendicitis.
When the imaging protocol parameters were as follows: abdomen or pelvis (intravenous contrast, 2 mg/kg, maximum 160 mL), scan timing (portal venous phase), range (from 4 cm above the liver dome to 1 cm below the ischial tuberosity), radiation dose (tube potential, KVP from 100 to 120), pitch 1.75:1, and reconstruction (5 mm, cut slice for adults; 3 mm, cut slice for children under 12 years old), anonymized CT images of patients were referred to a randomized dataset.
Exclusion Criteria:
Patients who did not fulfill the CT imaging protocol were excluded in detail as follows:
i) Failure to meet the CT protocol criteria of this study: liver CT, biliary CT, etc. (if contrast phase was different); ureter CT, etc. (if contrast media was not used and the reconstruction method was different); non-enhanced CT (when contrast media was not used); and appendix CT or low-dose CT (when radiation dose was low).
ii) When the quality of the CT image is significantly reduced, as follows: when blurring occurs (motion artifact) or metal artifact (when internal fixation is performed due to spinal surgery).
iii) when it was evident from the medical record review that clinical information suggested that APCT was performed due to the suspicion of a condition other than appendicitis, as follows: suspected acute cholecystitis due to RUQ tenderness and Murphy's sign; suspected urolithiasis due to flank pain and gross hematuria; suspected pancreatitis due to a history of pancreatitis; alcohol abuse; and suspected gynecological diseases due to vaginal discharge. Suspected panperitonitis due to whole abdominal tenderness, rebound tenderness, and unstable vital signs. Patients with acute cholecystitis, ureteral stones, pancreatitis, or acute peritonitis due to small bowel or colon perforation were also excluded.
iv) Patients younger than 10 years were excluded. Adolescent patients from 11 to 18 years old were included in the study if the exclusion criteria were not applicable.
v) diagnosed by ultrasound sonography vi) Patients who were transferred to the emergency department after a diagnosis of appendicitis at an outside hospital or ambulatory care were excluded.
vii) Patients with appendicitis who did not undergo surgical treatment because of the enrollment protocol of other ongoing studies.
viii) patients who had undergone an appendectomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT06175169
Study Brief:
Protocol Section:
NCT06175169