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NCT Number: NCT07222514

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Julia Yao

CONTACT

[email protected]

615-343-8426

About this study

This project will be conducted at Vanderbilt University Medical Center. Patients scheduled for a DIEP flap procedure will be recruited through screening of the electronic medical records (EMR) to evaluate eligibility based on pre-established inclusion and exclusion criteria. Eligible patients will be invited to participate in a preoperative consultation, during which they will receive detailed information about the study, including the surgical techniques, potential risks, and benefits. Written informed consent will be obtained from those who agree to participate.

Baseline data available in the medical records as part of their clinical care, including patient demographics, medical history, imaging, pictures, pain and quality-of-life metrics, will also be collected.

On the day of surgery, patients will undergo standard preoperative preparations. The procedure will involve robotic-assisted DIEP flap harvest using single-port access, followed by flap transfer and microsurgical anastomosis. Post-surgical donor site closure will employ techniques to minimize morbidity. Key intraoperative data, such as operative time and complications, will be recorded.

Patient Electronic Medical Records (EMR) will be accessed by research personnel to monitor patients who elect to have the proposed procedure. Postoperative monitoring will focus on flap viability and patient recovery during the hospital stay and subsequent follow-ups. Assessments will include complications, donor site integrity, pain levels, and patient-reported outcomes. Follow-up visits will evaluate both short- and long-term outcomes, including satisfaction and quality of life, providing comprehensive data for the study's primary and secondary aims.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single-Port Robotic System

Device

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.

Primary outcomes

  1. Feasibility of performing DIEP flap breast construction using a single port robotic system

    Time frame: From enrollment to the end of the procedure.

    This will be "Yes" if the following are true of the procedure: completed pedicle dissection using the robotic system, adequate pedicle dissected, and no intraoperative complication requiring conversion to the open approach.

Secondary outcomes

  1. Complication Rates

    Time frame: Through study completion, an average of 1 year.

    Intraoperative and postoperative complications. Including, but not limited to: flap failure, internal structure injuries, deep venous thrombosis, etc.

  2. Fascial Incision Length

    Time frame: Through study completion, an average of 1 year.

    Measurement of the fascial incision length and prevalence of abdominal herniation or bulging through the incision.

  3. Flap Success Rate

    Time frame: From procedure to 7 days post operation.

    We define flap success rate as survival of the flap without loss of viability through a specified time window.

  4. Operative Time

    Time frame: From procedure start to procedure completion.

    The time interval between first skin incision to skin closure of the patient.

  5. Pain Level

    Time frame: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.

    The patient level of pain on a scale of 1 (no pain) to 10 (extreme pain).

  6. Vascular Pedicle Length

    Time frame: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)

    The pedicle length used for anastomosis will be measured intraoperatively, reported in mm.

  7. Vanderbilt Mini Patient Reported Outcome - Breast (VMP-B) Score

    Time frame: From enrollment to 12 months post operation. Surveys will be distributed preoperatively and at postoperative follow up intervals (2 weeks, 6 weeks, 3 months, 6 months, and 12 months).

    The investigators will collect patient VMP-B (a validated patient reported outcome) scores to assess patient well being and satisfaction with their procedure. Items (16 total) are scored on a 5-point Likert scale, scores range from 16 (worst) to 80 (best).

  8. Pain Management

    Time frame: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.

    The investigators will record what analgesics are used to control patient pain.

  9. Vascular Pedicle Caliber

    Time frame: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)

    The pedicle caliber used for anastomosis will be measured intraoperatively, reported in mm.

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel Giannas, MD

CONTACT

[email protected]

6154033398

Jun Yao

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Intuitive Surgical

Registry information

Official study title

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

Acronym: (DIEP)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Oct 30, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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