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

RecruitingNAAges 18 Years - anyFemaleVanderbilt University Medical Center
NCT07222514 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Single-Port Robotic System
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Where

1 site
Vanderbilt University Medical Center
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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