New Era of DIEP With Minimally Invasive Mastectomy
Shifting Strategic Approach in Breast Reconstruction Using Free DIEP Flap Along With The Paradigm Shifting of Mastectomy Technique
1 other identifier
observational
278
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2023
CompletedFirst Submitted
Initial submission to the registry
March 14, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedMarch 20, 2024
March 1, 2024
12 months
March 14, 2024
March 14, 2024
Conditions
Outcome Measures
Primary Outcomes (7)
Endoscopy mastectomy
Post-operative day 0
Robotic mastectomy
Post-operative day 0
Incision
Post-operative day 0
Usage of SIEV
Post-operative day 0
Inclusion of bipedicle
Post-operative day 0
Location of recipient artery/vein
Post-operative day 0
Recipient artery/vein selection
Post-operative day 0
Study Arms (2)
Group A
Individuals who underwent surgery prior to November 2018
Group B
Individuals who underwent surgery after November 2018
Interventions
November 2018 as a temporal reference point was predicated on the milestone of the medical center's inaugural minimally invasive mastectomy procedure conducted
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients who did not meet the six-month follow-up duration was excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan District, 33305, Taiwan
Related Publications (1)
Lin TE, Wong AW, Cheong DC, Kuo WL, Tsai HP, Huang JJ. Strategically shifting paradigms: the new era of DIEP flaps with minimally invasive mastectomy: a retrospective cross-sectional study. BMC Cancer. 2024 Aug 30;24(1):1072. doi: 10.1186/s12885-024-12846-x.
PMID: 39210299DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jung-Ju Huang, MD
Chang Gung Memorial Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 14, 2024
First Posted
March 20, 2024
Study Start
October 3, 2022
Primary Completion
October 2, 2023
Study Completion
October 2, 2023
Last Updated
March 20, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share