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CT Carcinogenic Risk in Patients With Appendicitis

Carcinogenic Risk of CT in Patients With Appendicitis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03776435
Enrollment
1000000
Registered
2018-12-14
Start date
2018-01-15
Completion date
2021-05-15
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Carcinogenesis, Computed Tomography, Radiation Exposure

Brief summary

The purpose of this study is to compare the incidence rate of leukemia between CT-exposed and CT-unexposed group in patients who underwent appendectomy in South Korea.

Detailed description

South Korea has a single-payer healthcare system, administered by National Health Insurance Service (NHIS). As healthcare providers in South Korea need to claim reimbursement to NHIS for the vast majority of diagnostic and therapeutic procedures, the NHIS database enabled us to construct a large cohort who did or did not undergo CT for appendicitis. The purpose of this study is to compare the incidence rate of cancer between CT-exposed and CT-unexposed group in patients who underwent appendectomy in South Korea.

Interventions

RADIATIONAbdomen CT

Patients are divided into CT-exposed or unexposed group according to the presence of claims codes of abdominopelvic CT conducted within seven days before and after appendectomy. The seven-day threshold is arbitrarily determined considering the delay in the diagnosis of appendicitis and the postoperative examination for surgical complication.

Sponsors

National Research Foundation of Korea
CollaboratorOTHER
Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients will be entered in the cohort on the date of appendectomy under the diagnosis of appendicitis

Exclusion criteria

* (a) patients who had a cancer diagnosis before the date of appendectomy, * (b) those who had prior experience of CT examination more than 7 days before appendectomy, * (c) those who had syndromes or diseases predisposing cancers, * (d) those whose diagnosis was changed to appendiceal cancer and * (e) those whose follow-up duration was shorter than a lag period.

Design outcomes

Primary

MeasureTime frameDescription
Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic systemCancer occurrence after a lag period (2 years)Hematologic malignancies are categorized into lymphomas, multiple myeloma, leukemias, myelodysplasia and others using ICD-10 codes.

Secondary

MeasureTime frameDescription
Age and sex-standardized incidence rate ratio (IRR) for malignancies of abdominal organsCancer occurrence after a lag period (2 years)age and sex-standardized IRRs for malignancies of abdominal organs for CT-exposed versus unexposed patients.
Age and sex-standardized incidence rate ratio (IRR) for all cancersCancer occurrence after a lag period (2 years)age and sex-standardized IRRs for all cancers for CT-exposed versus unexposed patients.

Other

MeasureTime frameDescription
Sensitivity analysisCancer occurrence after different lag periods (6 months, 1 year, 3 years and 5 years)Various lag periods will be applied for the outcomes.
Subgroup analysis by subsequent CT scans conducted more than 7 days after appendectomyCT undergone more than 7 days after appendectomy will be counted.IRR in patients who underwent CT after appendectomy IRR in patients who did not undergo CT after appendectomy
Subgroup analysisCancer occurrence after a lag period (2 years)by age and sex

Countries

South Korea

Contacts

Primary ContactJi Hoon Park, MD
pjihoon79@gmail.com82-10-8526-0650
Backup ContactKyung Hee Lee, MD
kyung8404@gmail.com82-10-6686-8404

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026