Drainage Removal After Reverse-Sequence Endoscopic Nipple-Sparing Mastectomy With Direct-to-Implant Prepectoral Breast Reconstruction on Postoperative Safety and Patient Satisfaction : A National Multicenter, Open, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 379
- 试验地点
- 1
- 主要终点
- Aesthetic outcome evaluation--BREAST-Q scores
研究概览
简要总结
Breast cancer is a malignant tumor that seriously threatens the health of women, with an increasing incidence rate. The current main treatment methods include multidisciplinary diagnosis and treatment such as surgery, radiotherapy, chemotherapy, and endocrine therapy, among which surgery is the key. Postoperative care is also very important. Traditional breast surgery requires long-term placement of drainage tubes after the operation. However, long-term placement of drainage tubes increases the incidence of postoperative complications such as infection and delayed wound healing, prolongs hospital stays, increases economic burden, and also affects the aesthetic outcome. Our team has innovatively adopted the "reverse-sequence" endoscopic nipple-sparing-mastectomy with direct-to-implant breast reconstruction. This method is highly efficient and safe, with no incisions on the surface of the breast, reducing the risk of incision dehiscence and the probability of flap ischemia and necrosis. Based on this, our team proposes to appropriately relax the drainage criteria and remove the drainage tube earlier under the premise of ensuring the sterility of the effusion, and preliminary findings show that patients have better postoperative aesthetic outcomes, with a lower incidence of flap infection, ischemia, and necrosis than expected, and the degree of breast deformation caused by radiotherapy is also reduced. However, there is still controversy over the pros and cons of drainage criteria. Some scholars believe that strict drainage criteria can reduce the risk of infection and implant displacement, and plastic surgeons are more concerned about the impact of long-term tube placement on aesthetic outcomes and quality of life. Currently there is a lack of large sample, multicenter, randomized controlled studies to provide high - level evidence. Therefore, our team plans to conduct a national multicenter, open, randomized controlled study to compare the advantages and disadvantages of the two drainage methods under the premise of not reducing postoperative surgical and oncological safety, in order to explore the optimal timing for drain removal and improve patients' satisfaction with the reconstructed breast.
详细描述
This study is a multicenter, open, randomized controlled trial. Prior to group allocation, participants were stratified by axillary lymph node dissection. The proportion of patients undergoing axillary lymph node dissection is 25%, while the proportion of patients not undergoing axillary lymph node dissection is 75%. Following stratification, participants within each stratum were randomized in a 3:1 ratio to the intervention or control groups. The target sample size is 379 participants, comprising 95 in the ALND group (71 intervention, 24 control) and 284 in the non-ALND group (213 intervention, 71 control).
An interim analysis will occur 1 year after study initiation and 1 month post-enrollment completion. Final analysis follows 5-year postoperative follow-up for all participants. Categorical variables will be analyzed using chi-square or Fisher's exact tests; continuous variables via t-tests, ANOVA, or non-parametric alternatives (Mann-Whitney/Kruskal-Wallis) as appropriate. Survival outcomes will employ Kaplan-Meier curves with log-rank testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-70 years (inclusive);
- •Patients scheduled for unilateral or bilateral reverse-sequence endoscopic nipple-sparing- mastectomy with immediate prepectoral direct-to-implant breast reconstruction, with the option of concurrent contralateral endoscopic breast augmentation;
- •Patients with preoperative pathological confirmation of carcinoma in situ, invasive cancer, or those undergoing prophylactic mastectomy;
- •Patients with a maximum tumor diameter≤5 cm (before/after neoadjuvant chemotherapy), and no clinical or radiological evidence of nipple, skin, chest wall invasion, or distant metastasis;
- •BMI < 40 kg/m²;
- •Implant volume < 600 mL;
- •Patients who are able and willing to sign the informed consent form.
排除标准
- •History of breast surgery within 1 year prior to this operation (excluding VABB and biopsy);
- •Tumor invasion of the skin, pectoralis major muscle, chest wall, or nipple-areola complex;
- •Advanced tumor stage (M1);
- •Breast cancer during pregnancy or lactation;
- •Scars below the nipple level and a history of previous radiotherapy;
- •Patients with severe comorbidities before surgery, poorly controlled diabetes, immunodeficiency, or poor general condition that cannot tolerate surgery;
- •HbA1c > 7.5%;
- •Active smoking history (≥20 cigarettes per day);
- •Intraoperative flap burns, intraoperative nipple excision; postoperative complications such as infection, flap ischemia, or surgical cavity bleeding within 1-4 days after surgery; or other causes leading to incisions on the surface of the breast; patients who undergo nipple excision within 1 month after surgery should be excluded from the study;
- •Currently participating in other clinical studies that may affect participation in this trial.
- •Refusal to sign the informed consent form.
研究组 & 干预措施
Intervention group
Remove drainage tubes on postoperative day 5
干预措施: Drain Removal Timing After Endoscopic Breast Reconstruction Surgery (Procedure)
Control group
Remove drainage tubes when the daily drainage volume is less than 30 ml/day for two consecutive days after surgery.
结局指标
主要结局
Aesthetic outcome evaluation--BREAST-Q scores
时间窗: Preoperative (baseline), 3-month postoperative
The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores
次要结局
- Quality of Life--EORTC Quality of Life scores(14 days postoperative and 3 months postoperative)
- Drainage tube indwelling duration(Perioperative)
- Complications(3 months, 1 year and 2 years postoperative)
- wound care(3 months postoperative)
- Aesthetic outcome evaluation--BREAST-Q scores(2 years postoperative)
- Quality of Life--BREAST-Q scores(Preoperative (baseline), 3 months and 2 years postoperative)
- The total volume of drainage(Perioperative)
- Surgical margin involvement(2-3 weeks postoperative after paraffin-embedded pathological report available)
- Overall Survival(OS)(2-year postoperative and 5-year postoperative)
- Aesthetic outcome evaluation--Harris score(2-year postoperative)
- Aesthetic outcome evaluation--Ueda score(2-year postoperative)
- Local Recurrence-Free Survival(LRFS)(2-year postoperative and 5-year postoperative)
- Disease-Free Survival(DFS)(2-year postoperative and 5-year postoperative)
研究者
Du Zhenggui
Clinical Professor
West China Hospital