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

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

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).

Study Overview

• Status: Recruiting
• Conditions: DIEP Flap Breast Reconstruction
• Intervention / Treatment: Device: Single-Port Robotic System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanuel Giannas, MD; Phone Number: 6154033398; Email: e.giannas@vumc.org
• Study Contact Backup: Name: Jun Yao; Email: jun.yao@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Julia Yao; Phone Number: 615-343-8426; Email: jun.yao@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Assisted DIEP Breast Reconstruction; This group consists of patients receiving the investigative procedure - robotic assisted DIEP flap harvest for breast reconstruction.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Rates	Intraoperative and postoperative complications. Including, but not limited to: flap failure, internal structure injuries, deep venous thrombosis, etc.	Through study completion, an average of 1 year.
Fascial Incision Length	Measurement of the fascial incision length and prevalence of abdominal herniation or bulging through the incision.	Through study completion, an average of 1 year.
Flap Success Rate	We define flap success rate as survival of the flap without loss of viability through a specified time window.	From procedure to 7 days post operation.
Operative Time	The time interval between first skin incision to skin closure of the patient.	From procedure start to procedure completion.
Pain Level	The patient level of pain on a scale of 1 (no pain) to 10 (extreme pain).	From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.
Vascular Pedicle Length	The pedicle length used for anastomosis will be measured intraoperatively, reported in mm.	During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)
Vanderbilt Mini Patient Reported Outcome - Breast (VMP-B) Score	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).	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).
Pain Management	The investigators will record what analgesics are used to control patient pain.	From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.
Vascular Pedicle Caliber	The pedicle caliber used for anastomosis will be measured intraoperatively, reported in mm.	During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Intuitive Surgical
• Investigators: Principal Investigator: Galen Perdiks, MD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Roy N, Alessandro CJ, Ibelli TJ, Akhavan AA, Sharaf JM, Rabinovitch D, Henderson PW, Yao A. The Expanding Utility of Robotic-Assisted Flap Harvest in Autologous Breast Reconstruction: A Systematic Review. J Clin Med. 2023 Jul 27;12(15):4951. doi: 10.3390/jcm12154951.
• Tsai CY, Kim BS, Kuo WL, Liu KH, Chang TN, Cheong DC, Huang JJ. Novel Port Placement in Robot-Assisted DIEP Flap Harvest Improves Visibility and Bilateral DIEP Access: Early Controlled Cohort Study. Plast Reconstr Surg. 2023 Oct 1;152(4):590e-595e. doi: 10.1097/PRS.0000000000010470. Epub 2023 Mar 30.
• Lee MJ, Won J, Song SY, Park HS, Kim JY, Shin HJ, Kwon YI, Lee DW, Kim NY. Clinical outcomes following robotic versus conventional DIEP flap in breast reconstruction: A retrospective matched study. Front Oncol. 2022 Sep 14;12:989231. doi: 10.3389/fonc.2022.989231. eCollection 2022.
• Choi JH, Song SY, Park HS, Kim CH, Kim JY, Lew DH, Roh TS, Lee DW. Robotic DIEP Flap Harvest through a Totally Extraperitoneal Approach Using a Single-Port Surgical Robotic System. Plast Reconstr Surg. 2021 Aug 1;148(2):304-307. doi: 10.1097/PRS.0000000000008181.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 9, 2025
• First Submitted That Met QC Criteria: October 27, 2025
• First Posted (Actual): October 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Robotic Surgery; Breast Reconstruction; DIEP flap breast reconstruction
• Other Study ID Numbers: 250009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As this is a feasibility study - there is no indication to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes