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OpenTrials
Completed

NCT Number: NCT06321549

New Era of DIEP With Minimally Invasive Mastectomy

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.

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Key information

Conditions

Breast Reconstruction Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Mastectomy; Lymphedema

Sex eligibility

Female

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The reference point of minimally invasive mastectomy procedure conducted

Other

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

Primary outcomes

  1. Endoscopy mastectomy

    Time frame: Post-operative day 0

  2. Robotic mastectomy

    Time frame: Post-operative day 0

  3. Incision

    Time frame: Post-operative day 0

  4. Usage of SIEV

    Time frame: Post-operative day 0

  5. Inclusion of bipedicle

    Time frame: Post-operative day 0

  6. Location of recipient artery/vein

    Time frame: Post-operative day 0

  7. Recipient artery/vein selection

    Time frame: Post-operative day 0

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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