Feasibility and Safety of Single-Port Robotic-Assisted DIEP Flap Harvest for Breast Reconstruction: A Prospective Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Feasibility of performing DIEP flap breast construction using a single port robotic system
研究概览
简要总结
The primary aim of this study is to evaluate the feasibility of single-port robotic surgery for DIEP flap breast reconstruction. The investigators will also investigate complications of the procedure, incision length, flap success rate, post operative pain, vascular pedicle length and caliber, and VMP-B score (quality of life/satisfaction of breast procedures survey).
详细描述
This project will be conducted at Vanderbilt University Medical Center. Patients scheduled for a DIEP flap procedure will be recruited through screening of the electronic medical records (EMR) to evaluate eligibility based on pre-established inclusion and exclusion criteria. Eligible patients will be invited to participate in a preoperative consultation, during which they will receive detailed information about the study, including the surgical techniques, potential risks, and benefits. Written informed consent will be obtained from those who agree to participate.
Baseline data available in the medical records as part of their clinical care, including patient demographics, medical history, imaging, pictures, pain and quality-of-life metrics, will also be collected.
On the day of surgery, patients will undergo standard preoperative preparations. The procedure will involve robotic-assisted DIEP flap harvest using single-port access, followed by flap transfer and microsurgical anastomosis. Post-surgical donor site closure will employ techniques to minimize morbidity. Key intraoperative data, such as operative time and complications, will be recorded.
Patient Electronic Medical Records (EMR) will be accessed by research personnel to monitor patients who elect to have the proposed procedure. Postoperative monitoring will focus on flap viability and patient recovery during the hospital stay and subsequent follow-ups. Assessments will include complications, donor site integrity, pain levels, and patient-reported outcomes. Follow-up visits will evaluate both short- and long-term outcomes, including satisfaction and quality of life, providing comprehensive data for the study's primary and secondary aims.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Female patients aged ≥18 years.
- •Candidates for unilateral or bilateral breast reconstruction using a DIEP flap.
- •No contraindications for general anesthesia or robotic surgery.
- •Patients with adequate abdominal donor tissue for DIEP flap harvest.
排除标准
- •History of prior abdominal surgery that significantly compromises perforator vessel integrity.
- •Pregnant woman.
- •Prisoners.
- •BMI > 35, as measured during the preoperative evaluation.
- •Presence of comorbidities that contraindicate elective surgery.
- •Active cancer other than breast cancer at the time of evaluation.
- •Active metastatic disease confirmed via imaging or biopsy.
- •Inability to comply with follow-up visits.
- •The research team decides to exclude the patient.
研究组 & 干预措施
Robotic Assisted DIEP Breast Reconstruction
This group consists of patients receiving the investigative procedure - robotic assisted DIEP flap harvest for breast reconstruction.
干预措施: Single-Port Robotic System (Device)
结局指标
主要结局
Feasibility of performing DIEP flap breast construction using a single port robotic system
时间窗: From enrollment to the end of the procedure.
This will be "Yes" if the following are true of the procedure: completed pedicle dissection using the robotic system, adequate pedicle dissected, and no intraoperative complication requiring conversion to the open approach.
次要结局
- Complication Rates(Through study completion, an average of 1 year.)
- Fascial Incision Length(Through study completion, an average of 1 year.)
- Flap Success Rate(From procedure to 7 days post operation.)
- Operative Time(From procedure start to procedure completion.)
- Pain Level(From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.)
- Vascular Pedicle Length(During the operative procedure (approximately 6 - 10 hours, intraoperative measurement))
- Vanderbilt Mini Patient Reported Outcome - Breast (VMP-B) Score(From enrollment to 12 months post operation. Surveys will be distributed preoperatively and at postoperative follow up intervals (2 weeks, 6 weeks, 3 months, 6 months, and 12 months).)
- Pain Management(From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.)
- Vascular Pedicle Caliber(During the operative procedure (approximately 6 - 10 hours, intraoperative measurement))
研究者
Galen Perdikis
Chair and Professor, Department of Plastic Surgery
Vanderbilt University Medical Center