Single-port robotic DIEP flap harvest for breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Vanderbilt investigators will recruit adults scheduled for unilateral or bilateral DIEP flap breast reconstruction and obtain informed consent before surgery. Baseline clinical data from the electronic medical record and preoperative assessments will be collected. The procedure uses a single-port robotic system to harvest the DIEP flap, followed by standard flap transfer and microsurgical anastomosis, with intraoperative recording of operative time, complications, pedicle length and caliber, and incision length. Postoperative monitoring will track flap viability, donor-site outcomes, pain, quality-of-life (VMP-B) scores, and any complications during hospitalization and follow-up visits.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Galen Perdiks, MD — Vanderbilt University Medical Center
• Study coordinator: Emmanuel Giannas, MD
• Email: e.giannas@vumc.org
• Phone: 6154033398

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.