RecruitingNot ApplicableNCT07222514

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

Feasibility and Safety of Single-Port Robotic-Assisted DIEP Flap Harvest for Breast Reconstruction: A Prospective Evaluation


Sponsor

Vanderbilt University Medical Center

Enrollment

4 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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.

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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.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT07222514


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