Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy

July 4, 2023 updated by: Jung-Ju Huang, Chang Gung Memorial Hospital

Six Steps for a Successful Aesthetic Free Flap Reconstruction Shaping After Minimally Invasive Mastectomy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 33305
        • ChangGungMH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients who received nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Conventional mastectomy
Minimally invasive
robotic-assisted or endoscopic assisted mastectomies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful
Time Frame: post-operative 7 days
If the free flap transferred is successfully survived
post-operative 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2023

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

July 4, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202300895B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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