Single-port robotic DIEP flap harvest for breast reconstruction
Feasibility and Safety of Single-Port Robotic-Assisted DIEP Flap Harvest for Breast Reconstruction: A Prospective Evaluation
This project will test whether a single-port robotic technique can safely and effectively harvest DIEP flaps for adults having breast reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT07222514 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adult women (age 18 and older) who are candidates for unilateral or bilateral DIEP flap breast reconstruction with adequate abdominal donor tissue and no contraindications to general anesthesia or robotic surgery are ideal candidates.
Not a fit: Patients with significant prior abdominal surgery that compromises perforators, BMI over 35, active metastatic disease, pregnancy, major comorbidities that contraindicate elective surgery, or inability to comply with follow-up are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the technique could shorten incision length and reduce donor-site morbidity while maintaining high flap success for breast reconstruction patients.
How similar studies have performed: Robotic-assisted DIEP harvest has been reported in small series with promising results, but single-port robotic approaches are relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Galen Perdiks, MD — Vanderbilt University Medical Center
- Study coordinator: Jordan Johnson, BS
- Email: jordan.johnson.1@vumc.org
- Phone: 7138559208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.