Comparing the Safety and Cosmetic Outcomes Between Laparoscopic Versus Traditional Open Breast-conserving Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic breast-conserving surgery, Traditional open breast-conserving surgery.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Open and Prospective Randomized Controlled Trial Comparing the Safety and Cosmetic Outcomes of Laparoscopic Breast-conserving Surgery Versus Traditional Open Breast-conserving Surgery.
Overview
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
Detailed description
In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required to ensure the efficiency of cure. Also, less scars and breast preservation has becoming more and more important for patients' acceptance to the treatment. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.
Interventions
- Procedure Laparoscopic breast-conserving surgery
Use laparoscopic surgery to treat breast cancer patients who want and have the opportunity to preserve their breast - Procedure Traditional open breast-conserving surgery
Treat breast cancer patients who want and have the opportunity to preserve their breast with traditional open breast-conserving surgery.
Primary outcome measures
- breast appearance satisfaction [Time frame: 2 years]
- breast aesthetic scores [Time frame: 2 years]
Secondary outcome measures (3)
- Complications [Time frame: 1 year]
- Quality of Life [Time frame: 1 year]
- local recurrence rate [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Female over the age of 18
- Preoperative pathologically confirmed invasive breast cancer or ductal carcinoma in situ
- Clinical classification T1, T2 (maximum tumor diameter ≤5cm)
- Single-center tumor (preoperative confirmation by B-ultrasound, MRI and other imaging examinations)
- No clinical or imaging evidence of distant metastasis
- Able and willing to sign informed consent
Exclusion criteria
- Tumor in the lower inner quadrant
- Tumor in multiple quadrants
- Imaging or intraoperative pathology indicates tumor invasion of the nipple areola, skin, or pectoralis major
- Locally advanced breast cancer patients are undergoing neoadjuvant therapy
- Tumor in multiple quadrants
- Have been participating in other clinical trials, which may affect the participation in this trial
- Previous history of breast cancer (patients with recurrence after ipilateral breast-conserving surgery)
- Pregnant and lactating women
- Patients with severe cardiopulmonary disease or severely impaired lung function are not suitable for surgical establishment of an air cavity
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xiaochen Wang — Hangzhou
Identifiers
NCT: NCT06671249 · 2024-1251