Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.

Обзор

Evaluate the safety,feasibility and quality of life(QoL)of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment;

Подробное описание

Evaluate the safety and feasibility of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment; - Preoperative hospitalization period: Collect patient disease information (including mammography, breast ultrasound, breast enhanced MRI, etc.) - On the day of surgery: Record operating time, intraoperative blood loss, intraoperative complications, intraoperative adverse events, etc.; - Postoperative hospitalization period: Record postoperative complications (postoperative bleeding, necrosis of the flap or nipple-areola complex, subcutaneous emphysema, infection, capsule spasm, postoperative shoulder pain and discomfort, etc.), postoperative pain scores, postoperative pathological biopsy; - Postoperative hospital stay: Calculated from the day of surgery to the day of discharge; - 28 days postoperatively: Understand the complication rate and mortality rate within 28 days postoperatively; - 90 days postoperatively: Understand the complication rate and mortality rate within 90 days postoperatively; - 3-year disease-free survival period (calculated from the time of surgery to the last follow-up or recurrence and metastasis date, recurrence is defined as recurrence in the surgical area and distant metastasis); - 3-year overall survival rate (calculated from the time of surgery to the last follow-up or death).

In addition, postoperative quality of life and psychosocial satisfaction were assessed in all patients. Questionnaire surveys for quality of life were conducted at 1 week, 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after surgery.

Вмешательства

• Процедура robot-surgery
  Breast-conserving surgery for breast cancer using single-port robotic surgery.
• Процедура traditional open surgry
  Breast-conserving surgery for breast cancer using traditional open surgery.

Первичные конечные точки

• The successful rate of breast-conserving surgery [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Вторичные конечные точки (1)

• Post-surgery Quality of Life [Срок оценки: Post-suegery in 1 week, 1month,3months,6months,12moths,24months]

Критерии участия

Критерии включения

• The patient himself has very high requirements for beauty, and requires no scar on the chest;
• No chest surgery and radiotherapy.
• No contraindications to surgery and anesthesia.
• Clinical I, stage of early breast cancer and the breast has an appropriate volume, can maintain a good breast shape after surgery.
• Patients in the clinical period who meet the standard of breast conservation surgery after preoperative treatment.
• Age: 18 and 65 years old.

Критерии исключения

• Inflammatory breast cancer.
• The tumor is extensive and it's difficult to achieve negative margins or an ideal breast - conserving appearance.
• Diffusely distributed malignant - characteristic calcifications.
• The margin is positive after local extensive tumor resection, and a negative margin in pathological examination still can't be ensured after re - resection.
• The patient refuses.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Aramy medical center. — Чунцин
• Army Medical Center — Чунцин

Публикации

• Yu F, Zhang G, Guo L, Luo F, Chen Y, Xu Y. Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial. J Vis Exp. 2025 Aug 19;(222). doi: 10.3791/68459. PMID 40920680

Идентификаторы

NCT: NCT06738654 · AMCIIT241104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗