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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorXu Yan

About this trial

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;

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • robot-surgery

    Procedure/Surgery

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

  • traditional open surgry

    Procedure/Surgery

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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The successful rate of breast-conserving surgery

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.

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

Secondary outcomes

1

Post-surgery Quality of Life

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xu Yan

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Sponsor institution