New Era of DIEP With Minimally Invasive Mastectomy

NCT ID: NCT06321549

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

278 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-03

Study Completion Date

2023-10-02

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Reconstruction Mastectomy; Lymphedema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

Individuals who underwent surgery prior to November 2018

No interventions assigned to this group

Group B

Individuals who underwent surgery after November 2018

The reference point of minimally invasive mastectomy procedure conducted

Intervention Type OTHER

November 2018 as a temporal reference point was predicated on the milestone of the medical center's inaugural minimally invasive mastectomy procedure conducted

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Ju Huang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Ju Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 39210299 (View on PubMed)

Other Identifiers

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202201562B0

Identifier Type: -

Identifier Source: org_study_id

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