New Era of DIEP With Minimally Invasive Mastectomy

March 14, 2024 updated by: Jung-Ju Huang, Chang Gung Memorial Hospital

Shifting Strategic Approach in Breast Reconstruction Using Free DIEP Flap Along With The Paradigm Shifting of Mastectomy Technique

The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Supercharging of the second vein or inclusion of bilateral pedicle is commonly required. Current paradigm shifts in mastectomy has also resulted in more minimally invasive surgeries (MIS) espousing smaller lateral incisions, leading to a significant change in available recipient vessels. This study aimed to demonstrate our experience in changing strategies of DIEP flaps following the evolution of mastectomy techniques.

Between October 2008 and March 2022, retrospective data was gathered for 278 patients who underwent breast reconstruction surgery utilizing DIEP flaps by a single plastic surgeon. These patients were divided into two distinct groups based on their operation dates, with November 2018 marking a pivotal moment when the first MIS was introduced.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

278

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
        • Chang Gung Memorial Hospital

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

All patients who underwent breast reconstruction procedures with DIEP flaps from October 2008 to March 2022 from a single experienced reconstructive surgeon's practice at a medical institution.

Description

Inclusion Criteria:

  • All patients who underwent breast reconstruction procedures with DIEP flaps from October 2008 to March 2022.
  • Patients who have a minimum follow-up duration of six months post-reconstruction.

Exclusion Criteria:

  • Patients who did not meet the six-month follow-up duration was 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
Intervention / Treatment
Group A
Individuals who underwent surgery prior to November 2018
Group B
Individuals who underwent surgery after November 2018
Other: The reference point of minimally invasive mastectomy procedure conducted
November 2018 as a temporal reference point was predicated on the milestone of the medical center's inaugural minimally invasive mastectomy procedure conducted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endoscopy mastectomy
Time Frame: Post-operative day 0
Post-operative day 0
Robotic mastectomy
Time Frame: Post-operative day 0
Post-operative day 0
Incision
Time Frame: Post-operative day 0
Post-operative day 0
Usage of SIEV
Time Frame: Post-operative day 0
Post-operative day 0
Inclusion of bipedicle
Time Frame: Post-operative day 0
Post-operative day 0
Location of recipient artery/vein
Time Frame: Post-operative day 0
Post-operative day 0
Recipient artery/vein selection
Time Frame: Post-operative day 0
Post-operative day 0

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Jung-Ju Huang, MD, 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)

October 3, 2022

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

October 2, 2023

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202201562B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Subscribe