DIEP Flap Breast Reconstruction
Conditions
Keywords
DIEP flap breast reconstruction, Robotic Surgery, Breast Reconstruction
Brief summary
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).
Detailed description
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.
Interventions
DEVICESingle-Port Robotic System
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.
Sponsors
Vanderbilt University Medical Center
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of performing DIEP flap breast construction using a single port robotic system | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rates | Through study completion, an average of 1 year. | Intraoperative and postoperative complications. Including, but not limited to: flap failure, internal structure injuries, deep venous thrombosis, etc. |
| Fascial Incision Length | Through study completion, an average of 1 year. | Measurement of the fascial incision length and prevalence of abdominal herniation or bulging through the incision. |
| Flap Success Rate | From procedure to 7 days post operation. | We define flap success rate as survival of the flap without loss of viability through a specified time window. |
| Operative Time | From procedure start to procedure completion. | The time interval between first skin incision to skin closure of the patient. |
| Pain Level | From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30. | The patient level of pain on a scale of 1 (no pain) to 10 (extreme pain). |
| Vascular Pedicle Length | During the operative procedure (approximately 6 - 10 hours, intraoperative measurement) | The pedicle length used for anastomosis will be measured intraoperatively, reported in mm. |
| 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). | 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). |
| Pain Management | From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30. | The investigators will record what analgesics are used to control patient pain. |
| Vascular Pedicle Caliber | During the operative procedure (approximately 6 - 10 hours, intraoperative measurement) | The pedicle caliber used for anastomosis will be measured intraoperatively, reported in mm. |
Countries
United States
Contacts
CONTACTEmmanuel Giannas, MD
CONTACTJun Yao
PRINCIPAL_INVESTIGATORGalen Perdiks, MD
Vanderbilt University Medical Center
Outcome results
None listed