Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-Port Robotic System.
- Who it may be relevant to
- Registry conditions: DIEP Flap Breast Reconstruction. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility and Safety of Single-Port Robotic-Assisted DIEP Flap Harvest for Breast Reconstruction: A Prospective Evaluation
Overview
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).
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.
Interventions
- 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.
Primary outcome measures
- Feasibility of performing DIEP flap breast construction using a single port robotic system [Time frame: From enrollment to the end of the procedure.]
Secondary outcome measures (9)
- Complication Rates [Time frame: Through study completion, an average of 1 year.]
- Fascial Incision Length [Time frame: Through study completion, an average of 1 year.]
- Flap Success Rate [Time frame: From procedure to 7 days post operation.]
- Operative Time [Time frame: From procedure start to procedure completion.]
- Pain Level [Time frame: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.]
- Vascular Pedicle Length [Time frame: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)]
- 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).]
- Pain Management [Time frame: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.]
- Vascular Pedicle Caliber [Time frame: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
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. PMID 37568353
- 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. PMID 36995211
- 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. PMID 36185209
- 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. PMID 34398082
Identifiers
NCT: NCT07222514 · 250009