Health TrialsbyHealthPanel

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

ConditionDIEP Flap Breast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorVanderbilt University Medical Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

History of prior abdominal surgery that significantly compromises perforator vessel integrity.

Pregnant woman.

Prisoners.

BMI > 35, as measured during the preoperative evaluation.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

4 Participants
are divided into 1 treatment group
Group A: Robotic Assisted DIEP Breast ReconstructionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
From enrollment to the end of the procedure.

Secondary outcomes

1

Complication Rates

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

Time frame
Through study completion, an average of 1 year.
2

Fascial Incision Length

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

Time frame
Through study completion, an average of 1 year.
3

Flap Success Rate

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

Time frame
From procedure to 7 days post operation.
4

Operative Time

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

Time frame
From procedure start to procedure completion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

Intuitive Surgical

Collaborator

Source ClinicalTrials.gov
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