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NCT Number: NCT06629012

Autologous Nerve Graft Breast Reconstruction Neurotization

The goal of this observational study is to learn about the improvement of quality of life in accordance with breast neurotization in breast cancer patients. The patient-reported outcome was assessed by questionnaire.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Reconstruction Breast Cancer Patients Nipple-sparing Mastectomy

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient who receive breast reconstruction
  • Patient who is willing to fill in the questionnaire

Exclusion criteria

  • Patient who receive breast reconstruction for the reason other than breast cancer

Treatment and study plan

Breast reconstruction with neurotization

Procedure

Patients received breast reconstruction with neurotization procedure

Breast reconstruction without neurotization

Procedure

Patients received breast reconstruction without neurotization

Primary outcomes

  1. Pre-operative Quality of life

    Time frame: Before breast reconstructive surgery

    Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms

  2. Post-operative-two-year Quality of life

    Time frame: Two-year after breast reconstructive surgery

    Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms

  3. Post-operative-one-year Quality of life

    Time frame: One-year after breast reconstructive surgery

    Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Breast Neurotization During Breast Reconstruction Enhances Quality of Life

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

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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