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Nipple Neurotization

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Breast Reconstruction

Study type

Observational

Funder types

Other

Identifiers

NCT05897463
202201302B0

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

75 participants in 2 patient groups

Neurotized
Non-neurotized

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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