Autologous Nerve Graft Breast Reconstruction Neurotization

October 3, 2024 updated by: Jung-Ju Huang, Chang Gung Memorial Hospital

Breast Neurotization During Breast Reconstruction Enhances Quality of Life

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 33305
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing nipple-sparing mastectomy and immediate breast reconstruction

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Innervated group
Patients received breast neurotization
Procedure: Breast reconstruction with neurotization
Patients received breast reconstruction with neurotization procedure
Non-innervated group
Patients did not receive breast neurotization
Procedure: Breast reconstruction without neurotization
Patients received breast reconstruction without neurotization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before breast reconstructive surgery
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
Two-year after breast reconstructive surgery
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
One-year after breast reconstructive surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202101923B0-N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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