Autologous Nerve Graft Breast Reconstruction Neurotization

NCT06629012 | Active Not Recruiting

• 1 other identifier: 202101923B0-N
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction; Breast Cancer Patients; Nipple-sparing Mastectomy

Keywords

breast reconstruction; nipple-sparing mastectomy; breast neurotization; quality of life; autologous nerve graft; nipple sensation

Outcome Measures

Primary Outcomes (3)

• Pre-operative Quality of life

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

  Before breast reconstructive surgery

• Post-operative-two-year Quality of life

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

  Two-year after breast reconstructive surgery

• Post-operative-one-year Quality of life

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

  One-year after breast reconstructive surgery

Study Arms (2)

Innervated group

Patients received breast neurotization

Procedure: Breast reconstruction with neurotization

Non-innervated group

Patients did not receive breast neurotization

Procedure: Breast reconstruction without neurotization

Interventions

Breast reconstruction with neurotization PROCEDURE

Patients received breast reconstruction with neurotization procedure

Innervated group

Breast reconstruction without neurotization PROCEDURE

Patients received breast reconstruction without neurotization

Non-innervated group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing nipple-sparing mastectomy and immediate breast reconstruction

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

MeSH Terms

Interventions

Mammaplasty; Nerve Transfer

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative; Neurosurgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: November 29, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)