Nipple Neurotization

NCT ID: NCT05897463

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Reconstruction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Neurotized

No interventions assigned to this group

Non-neurotized

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Ju Huang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ChangGungMH

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202201302B0

Identifier Type: -

Identifier Source: org_study_id

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