Association of Breast Reconstruction Method With Long-term Risk of Psychiatric Disorders

Completed

• Conditions: Breast Cancer

• Registration Number: NCT06981689
• Lead Sponsor: Samsung Medical Center

Brief Summary

Female breast cancer patients who underwent total mastectomy followed by breast reconstruction

Detailed Description

Female breast cancer patients who underwent total mastectomy followed by breast reconstruction

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2025-04-23
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24930

Inclusion Criteria

• The study included newly diagnosed female breast cancer patients who underwent total mastectomy

Exclusion Criteria

• individuals who underwent reconstruction prior to mastectomy
• those diagnosed with psychiatric disorders within one year prior to surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychiatric disorders	1 year, 5 year and 9 year since surgery	The primary endpoint was clinically diagnosed psychiatric disorder, defined as the first occurrence of a diagnosis made by a physician for any of the following major psychiatric conditions: anxiety disorders (F40, F41), bipolar disorder (F30, F31, F34.0), depressive disorders (F32, F33), sleep disorders (G47.0, F51.0), obsessive-compulsive disorder (F42), posttraumatic stress disorder (F43.1), and substance use disorders (F10-F19).