Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05943873
Collaborator
(none)
63
1
5
383.5

Study Details

Study Description

Brief Summary

A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022. Patients will be grouped based on how the mastectomy was performed, via minimally invasive or conventional approach. Demographic data, flap profile, vessel anastomosis and post-operative complication will be retrospectively reviewed. Data collection includes patient demographics, previous breast surgical history, breast cancer history and adjuvant therapy, surgical details and postoperative events.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    63 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Six Steps for a Successful Aesthetic Free Flap Reconstruction Shaping After Minimally Invasive Mastectomy
    Actual Study Start Date :
    Jun 30, 2023
    Actual Primary Completion Date :
    Jul 5, 2023
    Actual Study Completion Date :
    Jul 5, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Control

    Conventional mastectomy

    Minimally invasive

    robotic-assisted or endoscopic assisted mastectomies

    Outcome Measures

    Primary Outcome Measures

    1. Successful [post-operative 7 days]

      If the free flap transferred is successfully survived

    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 nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon.
    Exclusion Criteria:
    • patients failed to be examined for outcome evaluation will be 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:
    NCT05943873
    Other Study ID Numbers:
    • 202300895B0
    First Posted:
    Jul 13, 2023
    Last Update Posted:
    Jul 13, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jung-Ju Huang, Associate Professor, Chang Gung Memorial Hospital

    Study Results

    No Results Posted as of Jul 13, 2023