CT Carcinogenic Risk in Patients With Appendicitis

NCT ID: NCT03776435

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-15

Study Completion Date

2021-05-15

Brief Summary

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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

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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.

Conditions

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Computed Tomography Carcinogenesis Radiation Exposure Appendicitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CT-exposed group

Abdomen CT

Intervention Type RADIATION

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.

CT-unexposed group

Abdomen CT

Intervention Type RADIATION

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.

Interventions

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Abdomen 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.

Intervention Type RADIATION

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ji Hoon Park

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bunadang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ji Hoon Park, MD

Role: CONTACT

82-10-8526-0650

Kyung Hee Lee, MD

Role: CONTACT

82-10-6686-8404

Facility Contacts

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Min Jeong Jeong

Role: primary

82-31-787-7607

Other Identifiers

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AppyCTcancer

Identifier Type: -

Identifier Source: org_study_id

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