Autologous Nerve Graft Breast Reconstruction Neurotization

Active, not recruiting

• Conditions: Breast Reconstruction; Breast Cancer Patients; Nipple-sparing Mastectomy
• Interventions: Procedure: Breast reconstruction with neurotization; Procedure: Breast reconstruction without neurotization

• Registration Number: NCT06629012
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-29
• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-03
• Study First Posted: 2024-10-07
• Last Update Posted: 2024-10-07
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Innervated group	Breast reconstruction with neurotization	Patients received breast neurotization
Non-innervated group	Breast reconstruction without neurotization	Patients did not receive breast neurotization

Primary Outcome Measures

Name	Time	Method
Pre-operative Quality of life	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
Post-operative-two-year Quality of life	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
Post-operative-one-year Quality of life	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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan