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Nipple Neurotization

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05897463
Enrollment
75
Registered
2023-06-09
Start date
2022-09-01
Completion date
2023-03-31
Last updated
2023-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction

Brief summary

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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes of monofilament force at 6, 12, 18, 24, and 30 months post-operativelypost-operative 6, 12, 18, 24, and 30 months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026