Clinical trial · Interventional
Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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;
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| robot-surgery | Procedure | — | UNRESOLVED |
| traditional open surgry | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Breast-conserving surgery for breast cancer using traditional open surgery.
- interventionNames
- Procedure: traditional open surgry
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- Breast-conserving surgery for breast cancer using single-port robotic surgery.
- interventionNames
- Procedure: robot-surgery
Primary outcomes (1)
- measure
- The successful rate of breast-conserving surgery
- timeFrame
- From enrollment to the end of treatment at 2 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 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.
References
Publications (1)
- DERIVEDYu 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