ORASIS and Microsurgical Anastomosis Outcomes in DIEP Flap Breast Reconstruction: A Crossover Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Mean anastomosis time (minutes)
研究概览
简要总结
The purpose of this study is to assess the use of ORASIS during microsurgical anastomosis formation in Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction and its potential effects on surgical precision, surgeon efficiency, and anastomosis outcomes. The investigators hypothesize that the use of ORASIS will decrease the amount of time needed to perform microsurgical anastomoses, reduce interruptions for irrigation and suction, and increase the quality of anastomoses in DIEP flap breast reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Female Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction patients who have received a prior mastectomy (either unilateral or bilateral) on the breast undergoing reconstruction
- •Patients who received mastectomies for oncologic or prophylactic indications
- •Patients receiving either immediate or delayed DIEP flap breast reconstruction
- •Age 18 or older at the time of patient consent and DIEP flap surgery
排除标准
- •History of any prior tissue expander placement or breast reconstruction on the breast undergoing DIEP flap reconstruction
- •Patients receiving DIEP flap breast reconstruction for indications other than oncologic or prophylactic post-mastectomy breast reconstruction
- •Under the age of 18 at the time of patient consent or DIEP flap surgery
研究组 & 干预措施
Control Arm
In the control arm, surgeons will perform two microsurgical anastomoses without the use of ORASIS in either bilateral or unilateral Deep Inferior Epigastric Perforator (DIEP) flap reconstruction. If bilateral DIEP flap reconstruction is performed in the control arm, only the first microsurgical anastomosis for each bilateral DIEP flap reconstruction will be assessed. In both study arms, surgeons will perform end-to-end anastomosis using current standard-of-care techniques. This will include the formation of anastomoses between the deep inferior epigastric artery (DIEA) perforators and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures, as well as the deep inferior epigastric vein (DIEV) perforators and internal mammary vein (IMV).
ORASIS Arm
In the ORASIS arm, surgeons will perform two microsurgical anastomoses with the use of ORASIS in either bilateral or unilateral Deep Inferior Epigastric Perforator (DIEP) flap reconstruction. If bilateral DIEP flap reconstruction is performed in the treatment arm, ORASIS will only be used in the first microsurgical anastomosis performed in each bilateral DIEP flap reconstruction; only the breast reconstructed with the use of ORASIS will be assessed. In both study arms, surgeons will perform end-to-end anastomosis using current standard-of-care techniques. This will include the formation of anastomoses between the deep inferior epigastric artery (DIEA) and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures, as well as the deep inferior epigastric vein (DIEV) perforators and internal mammary vein (IMV).
干预措施: Use of ORASIS Device (Device)
结局指标
主要结局
Mean anastomosis time (minutes)
时间窗: From first suture placement to anastomosis completion
Total anastomosis time will be defined as the number of minutes from first suture placement to anastomosis completion.
Mean ischemia time (minutes)
时间窗: From pedicle transection to anastomosis completion
Total ischemia time will be defined as the number of minutes from flap division to flap reperfusion.
次要结局
- Mean number of interruptions per procedure(From beginning of microsurgical anastomosis to end of microsurgical anastomosis)
- Surgeon Survey(Within 1 month after conclusion of DIEP flap surgery procedure)
- Incidence of postoperative complications 0-48 hours after procedure(Within 48 hours after DIEP flap surgery)
- Mean NASA-TLX (Task Load Index) score(From beginning of microsurgical anastomosis to end of microsurgical anastomosis)
- Mean Surgical Assessment Metric Scale (SAMS) overall scores(From beginning of microsurgical anastomosis to end of microsurgical anastomosis)