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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05897463
Other study ID # 202201302B0
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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