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

Recruiting now · Not applicable

Conditions studied: DIEP Flap Breast Reconstruction

In brief

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).

Key facts

Study ID

NCT07222514

Run by

Vanderbilt University Medical Center

People needed

4

Starts

2026-05-20

Expected to finish

2028-12-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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