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OpenTrials
Completed

NCT Number: NCT06981689

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

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

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Mental Disorders Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Psychiatric disorders

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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