Clincosm LogoSign in Get a demo

Nipple Neurotization

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05897463
Collaborator
(none)
75
Enrollment
1
Location
6.9
Actual Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    75 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Breast and Nipple Neurotization Via Elongation of the Lateral Cutaneous Branches Using Intercostal Branches
    Actual Study Start Date :
    Sep 1, 2022
    Actual Primary Completion Date :
    Mar 31, 2023
    Actual Study Completion Date :
    Mar 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Neurotized
    Non-neurotized

    Outcome Measures

    Primary Outcome Measures

    1. Changes of monofilament force at 6, 12, 18, 24, and 30 months post-operatively [post-operative 6, 12, 18, 24, and 30 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ChangGungMH Taoyuan Taiwan 33305

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jung-Ju Huang, Associate Professor, Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT05897463
    Other Study ID Numbers:
    • 202201302B0
    First Posted:
    Jun 9, 2023
    Last Update Posted:
    Jun 9, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 9, 2023