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

NCT06981689 | Completed

• 1 other identifier: AR vs. IBR
• Study Type: observational
• Target: 24,930
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer

Keywords

autologous reconstruction; implant-based reconstruction; psychiatric disorders

Outcome Measures

Primary Outcomes (1)

• Psychiatric disorders

  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).

  1 year, 5 year and 9 year since surgery

Study Arms (2)

autologous reconstruction

autologous reconstruction following mastectomy

implant-based reconstruction

implant-based reconstruction following mastectomy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biologically female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included newly diagnosed female breast cancer patients who underwent total mastectomy followed by breast reconstruction classified into two types using ICD-10 procedure codes: autologous tissue reconstructions were coded from N7140 to N7147 and implant-based reconstructions were coded from N7148 to N7151 Exclusions applied to males, individuals who underwent reconstruction prior to mastectomy, and those diagnosed with psychiatric disorders within one year prior to surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Breast Neoplasms; Mental Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

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

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 21, 2025
• Study Start: January 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share