Preoperative Imagining in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial Evaluating Cost and Patient-Reported Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in BREAST-Q Scores
研究概览
简要总结
The purpose of this study is to determine whether preoperative abdominal imaging using either CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and patient outcomes in DIEP flap breast reconstruction.
详细描述
This study will prospectively compare the clinical, economic and patient outcomes of preoperative imaging using either CTA or MRA with those of no preoperative imaging in patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction. Subjects will randomly undergo either a CTA scan or an MRA scan, or no scan (control) preoperatively. An operative plan based on perforator size and course will be devised by an interventional radiologist and a plastic surgeon. The DIEP flap procedure will be planned for controls.
Subjects will not be told if the operative plan is changed intraoperatively. Flap dissection time and changes in operative plan will be recorded intraoperatively and surgeon stress will be evaluated following surgery. Pain and narcotic use will be evaluated preoperatively and on days 1-4 postoperatively. The Breast-Q will be completed preoperatively and at 3 weeks, 3 months and 12 months postoperatively. Groups will be compared in terms of all variables measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •candidate for DIEP flap breast reconstruction
- •speak/read/write English
- •have undergone or will undergo unilateral or bilateral mastectomy
排除标准
- •previous abdominal surgery that may preclude a DIEP flap reconstruction
- •active smoker
- •BMI over 35
- •severe claustrophobia
- •sensitivity to intravenous CT contrast medium (Visipaque 320) or MR contrast medium (Gadovist 1.0)
- •urgency of surgery that precludes study enrollment
结局指标
主要结局
Change in BREAST-Q Scores
时间窗: Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months
Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction.
Time for flap dissection
时间窗: 1 day - during surgery
Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure.
次要结局
- Change in Memorial Pain Assessment Card (MPAC) Scores(Baseline, postoperatively on the first 4 days, and at 3 weeks, 3 months and 12 months)
- NASA-Task Load Index (TLX)(once - immediately postoperatively)
- Economic Outcome(1 year)
- Whether change in operative procedure occurred during surgery(1 day)