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NCT Number: NCT06738654

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

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;

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aramy medical center., Chongqing, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

robot-surgery

Procedure

Breast-conserving surgery for breast cancer using single-port robotic surgery.

traditional open surgry

Procedure

Breast-conserving surgery for breast cancer using traditional open surgery.

Primary outcomes

  1. The successful rate of breast-conserving surgery

    Time frame: From enrollment to the end of treatment at 2 weeks

    Whether intraoperative frozen section biopsy of the surgical margins detects cancer cells; if it is negative after two or fewer attempts, then the breast-conserving surgery is considered successful.

Secondary outcomes

  1. Post-surgery Quality of Life

    Time frame: Post-suegery in 1 week, 1month,3months,6months,12moths,24months

Study contacts

Contact information is provided by the study sponsor or research team.

yan xu Xu, Doctor

CONTACT

[email protected]

023-68729250

Sponsors and collaborators

Lead sponsor

Xu Yan

Other

Registry information

Acronym: 单孔机器人-SPR

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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