Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest ((DIEP))

Vanderbilt University Medical Center

Status

Not yet enrolling

Conditions

DIEP Flap Breast Reconstruction

Treatments

Device: Single-Port Robotic System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07222514

250009

Details and patient eligibility

About

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).

Full 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.

Enrollment

4 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.