Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer. (单孔机器人-SPR)

May 30, 2026 updated by: Xu Yan
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;

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: yan xu Xu, Doctor
  • Phone Number: 023-68729250
  • Email: xy931@163.com

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400042
        • Not yet recruiting
        • Aramy medical center.
        • Contact:
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Army Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Breast-conserving surgery for breast cancer using traditional open surgery.
Procedure: traditional open surgry
Breast-conserving surgery for breast cancer using traditional open surgery.
Experimental: Experimental Group
Breast-conserving surgery for breast cancer using single-port robotic surgery.
Procedure: robot-surgery
Breast-conserving surgery for breast cancer using single-port robotic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-surgery Quality of Life
Time Frame: Post-suegery in 1 week, 1month,3months,6months,12moths,24months
Post-suegery in 1 week, 1month,3months,6months,12moths,24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xu Yan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2024

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCIIT241104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

it contains privacy about patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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