A Multi-institutional Trial Comparing Clinical Outcomes Following Low- vs. Standard-dose Abdominal CT as the First-line Imaging Test in Adolescents and Young Adults With Suspected Acute Appendicitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,074
- Locations
- 20
- Primary Endpoint
- Negative Appendectomy Rate
Study Overview
Brief Summary
To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed tomography (CT) as the first-line imaging test in adolescents and young adults in regard to negative appendectomy rate (NAR).
Detailed Description
- Acute appendicitis is a very common disease. Many patients are adolescents or young adults.
- CT is the current standard imaging test for the diagnosis of appendicitis.
- In recent years, the awareness of carcinogenic risk associated with CT radiation has increased.
- According to a recent single-institutional randomized controlled trial, LD CT (employing a quarter of standard radiation dose) was found to be noninferior to SD CT with respect to NARs in adolescents and young adults with suspected appendicitis.
- However, LD CT is not yet widely accepted.
- To establish LD CT as the first-line imaging test, a multi-institutional study is needed to confirm the generalizability of the prior single-institutional study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 44 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Emergency department visit with suspected symptoms and signs of acute appendicitis
- •Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis
- •Willing to provide telephone or cell phone numbers for follow-up
- •Signed informed consent provided prior to study entry
Exclusion Criteria
- •Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs
- •Prior history of surgical removal of the appendix
Arms & Interventions
Low-dose CT
Diagnostic CT with low-dose radiation
Intervention: Diagnostic CT with low-dose radiation (Diagnostic Test)
Standard-dose CT
Diagnostic CT with standard-dose radiation
Intervention: Diagnostic CT with standard-dose radiation (Diagnostic Test)
Outcomes
Primary Outcomes
Negative Appendectomy Rate
Time Frame: 1 week after surgery
Negative appendectomy rate was defined as the percentage of negative (unnecessary) appendectomies among all non-incidental appendectomies. As a secondary analysis, negative appendectomy rate in an alternative definition was calculated by excluding cases with appendiceal neoplasms without superimposed appendicitis, as appendectomy would be clinically necessary in such patients. Any surgery performed for the treatment of presumed appendicitis was counted as non-incidental appendectomy, even though the surgical procedures were more extensive than simple appendectomy (e.g., ileocectomy).
Secondary Outcomes
- Prevalence of Perforated Appendicitis(1 week after surgery)
- Number of Appendectomies(3 months after CT)
- Number of Negative Appendectomies(1 week after surgery)
- Prevalence of Non-perforated Appendicitis(1 week after surgery)
- Appendiceal Perforation Rate(1 week after surgery)
- Need for Additional Imaging Test(s)(1 week after CT)
- Delay in Patient Disposition(3 months after CT)
- Length of Hospital Stay Associated With Appendectomy(3 months after CT)
- Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Indeterminate Interpretation (Grade 3)(3 months after CT)
- Diagnostic Performance of CT Reports - Sensitivity and Specificity(3 months after CT)
- Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Likelihood Score for Appendicitis(3 months after CT)
- Diagnostic Confidence in Ruling Out Appendicitis: Normal Appendix Visualization(3 months after CT)
- Diagnosis of Appendiceal Perforation at CT(3 months after CT)
- Diagnostic Performance of CT Reports - AUC(3 months after CT)
Investigators
Kyoung Ho Lee, MD
Professor
Seoul National University Bundang Hospital