Last reviewed · How we verify

NCT06321549

New Era of DIEP With Minimally Invasive Mastectomy

Completed Last updated 20 March 2024
What this trial tests

trial testing The reference point of minimally invasive mastectomy procedure conducted in Breast Reconstruction in 278 participants. Completed in 2 October 2023.

Timeline
3 October 2022
Primary endpoint
2 October 2023
2 October 2023

Quick facts

Lead sponsorChang Gung Memorial Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment278
Start date3 October 2022
Primary completion2 October 2023
Estimated completion2 October 2023
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Chang Gung Memorial Hospital

Who can join

Eligibility, female only, with Breast Reconstruction or Mastectomy; Lymphedema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Strategically shifting paradigms: the new era of DIEP flaps with minimally invasive mastectomy: a retrospective cross-sectional study.
    Lin TE, Wong AW, Cheong DC, Kuo WL, et al · · 2024 · cited 2× · PMID 39210299 · DOI 10.1186/s12885-024-12846-x

Verify or expand the search:

Other recruiting trials for Breast Reconstruction

Currently open trials in the same condition.

Other Chang Gung Memorial Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06321549.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing