Nipple Neurotization

Completed

• Conditions: Breast Reconstruction

• Registration Number: NCT05897463
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Study First Submitted: 2023-05-23
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Study First Posted: 2023-06-09
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of monofilament force at 6, 12, 18, 24, and 30 months post-operatively	post-operative 6, 12, 18, 24, and 30 months

Trial Locations

Locations (1)

ChangGungMH; 🇨🇳 Taoyuan, Taiwan