Skip to main content
OpenTrials
Completed

NCT Number: NCT05897463

Nipple Neurotization

A retrospective chart review will be conducted to identify patients receiving breast reconstruction and simultaneous breast neurotization. Their reconstructed breasts will be included as study group. Patients receiving breast reconstruction without neurotization will be included as negative control group. Their contralateral normal breasts in the study and the negative control group will be included as positive control. Patients' demographic data, their breast cancer treatment parameters, such as the staging, previous radiotherapy history, postmastectomy radiotherapy, neoadjuvant and adjuvant chemotherapy will be included. The reconstruction results will be evaluated as well.

Statistics Data will be analyzed using graphing and statistical analysis software. Independent t test will be applied to calculate continuous variables in demographic values, while Chi-square will be applied to calculate categorical variables such as postoperative complications. A probability of less than 0.05 will be considered significant.

Potential risks: No

Confidentiality:

All the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Reconstruction

Sex eligibility

Female

Study type

Observational

Primary location

ChangGungMH

Taoyuan, 33305, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who received breast reconstruction and neurotization from July 2019 to August 2022 from a single breast reconstruction surgeon.
  • patients who received breast reconstruction without neurotization were included as the non-neurotized group.

Exclusion criteria

  • patients unable to complete the follow-up were excluded from the study

Treatment and study plan

Primary outcomes

  1. Changes of monofilament force at 6, 12, 18, 24, and 30 months post-operatively

    Time frame: post-operative 6, 12, 18, 24, and 30 months

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Breast and Nipple Neurotization Via Elongation of the Lateral Cutaneous Branches Using Intercostal Branches

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2023
Registry last updated
Jun 9, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.