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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
Utilizing the Single-Port robotic system for DIEP flap harvest has been previously described, but only in a small pilot study. The investigators plan to demonstrate the feasibility and safety of this approach on a larger cohort of patients.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGFeasibility of performing DIEP flap breast construction using a single port robotic system
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.
Time frame: From enrollment to the end of the procedure.
Complication Rates
Intraoperative and postoperative complications. Including, but not limited to: flap failure, internal structure injuries, deep venous thrombosis, etc.
Time frame: Through study completion, an average of 1 year.
Fascial Incision Length
Measurement of the fascial incision length and prevalence of abdominal herniation or bulging through the incision.
Time frame: Through study completion, an average of 1 year.
Flap Success Rate
We define flap success rate as survival of the flap without loss of viability through a specified time window.
Time frame: From procedure to 7 days post operation.
Operative Time
The time interval between first skin incision to skin closure of the patient.
Time frame: From procedure start to procedure completion.
Pain Level
The patient level of pain on a scale of 1 (no pain) to 10 (extreme pain).
Time frame: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.
Vascular Pedicle Length
The pedicle length used for anastomosis will be measured intraoperatively, reported in mm.
Ricardo Torres Guzman, MD
CONTACT
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NONE
Enrollment
4
Time frame: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)
Vanderbilt Mini Patient Reported Outcome - Breast (VMP-B) Score
The investigators will collect patient VMP-B (a validated patient reported outcome) scores to assess patient well being and satisfaction with their procedure. Items (16 total) are scored on a 5-point Likert scale, scores range from 16 (worst) to 80 (best).
Time frame: 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
The investigators will record what analgesics are used to control patient pain.
Time frame: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.
Vascular Pedicle Caliber
The pedicle caliber used for anastomosis will be measured intraoperatively, reported in mm.
Time frame: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)