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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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DIEP Flap Breast Reconstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Robotic Assisted DIEP Breast Reconstruction

This group consists of patients receiving the investigative procedure - robotic assisted DIEP flap harvest for breast reconstruction.

Group Type EXPERIMENTAL

Single-Port Robotic System

Intervention Type 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.

Interventions

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Single-Port Robotic System

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No