CT Carcinogenic Risk in Patients With Appendicitis

• Conditions: Computed Tomography; Radiation Exposure; Appendicitis; Carcinogenesis
• Interventions: Radiation: Abdomen CT

• Registration Number: NCT03776435
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-14
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17
• Primary Completion: 2020-12-15
• Study Completion: 2021-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CT-exposed group	Abdomen CT	-
CT-unexposed group	Abdomen CT	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bunadang Hospital; 🇰🇷 Seongnam-Si, Gyeonggi-do, Korea, Republic of