Nipple Neurotization

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897463
• Other study ID #: 202201302B0
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction

Locations

Country	Name	City	State
Taiwan	ChangGungMH	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of monofilament force at 6, 12, 18, 24, and 30 months post-operatively		post-operative 6, 12, 18, 24, and 30 months