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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Feasibility of performing DIEP flap breast construction using a single port robotic system [Срок оценки: From enrollment to the end of the procedure.]

Вторичные конечные точки (9)

• Complication Rates [Срок оценки: Through study completion, an average of 1 year.]
• Fascial Incision Length [Срок оценки: Through study completion, an average of 1 year.]
• Flap Success Rate [Срок оценки: From procedure to 7 days post operation.]
• Operative Time [Срок оценки: From procedure start to procedure completion.]
• Pain Level [Срок оценки: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.]
• Vascular Pedicle Length [Срок оценки: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)]
• Vanderbilt Mini Patient Reported Outcome - Breast (VMP-B) Score [Срок оценки: 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 [Срок оценки: From procedure to postoperative day (POD) 1, 2, 3, 7, 14, and 30.]
• Vascular Pedicle Caliber [Срок оценки: During the operative procedure (approximately 6 - 10 hours, intraoperative measurement)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Публикации

• 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

Идентификаторы

NCT: NCT07222514 · 250009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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