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

Association of Breast Reconstruction Method With Long-term Risk of Psychiatric Disorders: A Target Trial Emulation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06981689

Enrollment

24930

Registered

2025-05-21

Start date

2015-01-01

Completion date

2023-12-31

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

autologous reconstruction, implant-based reconstruction, psychiatric disorders

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Outcome results