CT Carcinogenic Risk in Patients With Appendicitis

NCT03776435 | Unknown

• 1 other identifier: AppyCTcancer
• Study Type: observational
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Computed Tomography; Carcinogenesis; Radiation Exposure; Appendicitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Cancer occurrence after a lag period (2 years)

Secondary Outcomes (2)

• 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 incidence rate ratio (IRR) for all cancers

  Cancer occurrence after a lag period (2 years)

Other Outcomes (3)

• Sensitivity analysis

  Cancer occurrence after different lag periods (6 months, 1 year, 3 years and 5 years)

• Subgroup analysis by subsequent CT scans conducted more than 7 days after appendectomy

  CT undergone more than 7 days after appendectomy will be counted.

• Subgroup analysis

  Cancer occurrence after a lag period (2 years)

Study Arms (2)

CT-exposed group

Radiation: Abdomen CT

CT-unexposed group

Radiation: Abdomen CT

Interventions

Abdomen CT 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-exposed group; CT-unexposed group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent appendectomy under the diagnosis of appendicitis

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Seoul National University Bunadang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinogenesis; Appendicitis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 14, 2018
• Study Start: January 15, 2018
• Primary Completion: December 15, 2020
• Study Completion: May 15, 2021
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)