CT Carcinogenic Risk in Patients With Appendicitis

Seoul National University Bundang Hospital1,000,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000,000

Conditions

Computed Tomography Carcinogenesis Radiation Exposure Appendicitis

Interventions

Abdomen CTRADIATION

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Bunadang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic system

Hematologic malignancies are categorized into lymphomas, multiple myeloma, leukemias, myelodysplasia and others using ICD-10 codes.

Time frame: Cancer occurrence after a lag period (2 years)

Secondary Outcomes

Age and sex-standardized incidence rate ratio (IRR) for malignancies of abdominal organs

age and sex-standardized IRRs for malignancies of abdominal organs for CT-exposed versus unexposed patients.

Time frame: Cancer occurrence after a lag period (2 years)

Age and sex-standardized incidence rate ratio (IRR) for all cancers

age and sex-standardized IRRs for all cancers for CT-exposed versus unexposed patients.

Time frame: Cancer occurrence after a lag period (2 years)

Central Contacts

Ji Hoon Park, MD

CONTACT

82-10-8526-0650 pjihoon79@gmail.com

Kyung Hee Lee, MD

CONTACT

82-10-6686-8404 kyung8404@gmail.com

Data from ClinicalTrials.gov

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