跳至主要内容
临床试验/NCT06321549
NCT06321549已完成不适用

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

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
278
试验地点
1
主要终点
Robotic mastectomy

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • Patients who did not meet the six-month follow-up duration was excluded from the study.

结局指标

主要结局

Robotic mastectomy

时间窗: Post-operative day 0

Incision

时间窗: Post-operative day 0

Endoscopy mastectomy

时间窗: Post-operative day 0

Usage of SIEV

时间窗: Post-operative day 0

Inclusion of bipedicle

时间窗: Post-operative day 0

Recipient artery/vein selection

时间窗: Post-operative day 0

Location of recipient artery/vein

时间窗: Post-operative day 0

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung-Ju Huang

Associate Professor

Chang Gung Memorial Hospital

研究点 (1)

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