Quality of Life and Cosmetic Outcomes of Breast-Conserving Surgery According to Localization Method (TRIGUIDE Trial) - A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- BCCT.core
研究概览
简要总结
The goal of this clinical trial is to compare Quality of Life and cosmetic outcomes in Breast Conservative Carcer surgery depending on localization method (intraoperative Ultrasound, wire and radioactive seed).
Participants will be randomly assigned to one of the three proposed arms, and the primary surgery will be performed.
详细描述
INTRODUCTION:
The surgery for breast cancer is increasingly emphasizing cosmetic outcomes, body image, and the quality of life (QoL) of patients. Survival is the top priority; however, other concerns or problem areas may arise, such as dissatisfaction with body image. All of this has implications for QoL, self-esteem, relationships, and sexual functionality. One of the challenges of breast conservative surgery (BCS) is suboptimal cosmetic results, which can be observed in up to 40% of patients in some series. Factors influencing the cosmetic outcome include patient characteristics such as weight or breast density, the volume of the tumor removed, the tumor's location in the breast, wound complications, and the dose and schedule of radiotherapy. Therefore, the use of low-visibility incisions, precise tumor resection, and the introduction of oncoplastic techniques have revolutionized the surgical management of these patients.
The localization of the lesion is a key point for surgical resection. Advancements in imaging diagnostic methods and molecular classification have led to a reevaluation of surgical approaches. The widespread use of mammography as a screening method for breast cancer has resulted in an increase in the detection of non-palpable breast lesions, necessitating the search for tools to detect these lesions. The intent of surgery should always be both radical and effective, meaning achieving the removal of the loco-regional disease. The main challenge in breast surgery lies in striking a balance between wide excision with clear margins and a satisfactory cosmetic outcome Currently, there are multiple localization techniques available, although the evidence from comparative studies is limited. Wire guided localization (WGL) is considered the standard method for intraoperative localization of non-palpable breast lesions and is the method of choice for many centers worldwide. However, alternative localization techniques such as radioguided occult lesion localization using radioactive iodine-125 seeds (RSL) and ultrasound guided surgery (UGS) have recently been shown to reduced re-excision rates. In a systematic review comparing different localization methods, UGS reduced the percentage of involved margins and significantly decreased the reoperation rate and surgical time when compared to WGL. UGS also showed a statistically significant reduction in the number of involved margins compared to RSL. All techniques were equivalent in terms of effectiveness, localization complications, and general complications. The available evidence on cosmetic outcomes and QoL in BCS according to the localization technique is limited.
We hypothesized UGS and RSL would be associated with a better QoL and cosmetic outcome compared to WGL. The aim of TRIGUIDE study was to compare the QoL and cosmetic outcomes of women who underwent BCS according the localization method.
METHOD/PROCEDURES:
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with non-palpable and ecovisible infiltrating breast carcinoma, classified as T1 and T2, eligible for primary breast-conserving surgery (BCS)
排除标准
- •lesions <5mm
- •multicentric tumors
- •extensive calcifications not visible by ultrasound
- •level III oncoplastic techniques or mastectomy
结局指标
主要结局
BCCT.core
时间窗: 12 months after surgery
BCCT.core is a semi-automatic software validated for the assessment of cosmetic outcomes following BCS. It provides an objective measure and has been demonstrated to correlate well to a panel of experts. BCCT.core analyses several parameters including symmetry, skin colour and scar visibility to evaluate breast cosmesis, and classifies the overall cosmetic result into four classes: Excellent, Good, Fair and Poor. However, BCCT.core does not incorporate patient self-perception of outcome and does not directly assess the volume of breast excised. Standardized clinical photographs were taken 1-year post-surgery with or without radiotherapy, as recommended by the BCCT.core software developers and assessed at the end of the data collection period by a single investigator, blinded to the identification and treatment group of the participant.
BREAST-Q questionnaire
时间窗: preoperative, 12 months after surgery
The BREAST-Q questionnaire is a specific and validated Patient-Reported Outcome Measure (PROM) for patients undergoing breast surgery designed to assess the outcomes and satisfaction of individuals, which measures health-related QoL (physical well-being, psychological and sexual) and satisfaction (satisfaction with the breast, satisfaction with the overall result and satisfaction with the care received). Each scale is scored to generate a numeric score on a scale from 0 (worst) to 100 (best). These measures were studied at baseline (preoperative) and 12 months post-surgery.
次要结局
- Excess volume resection(Inmediatly after surgery)
- Margin status(Inmediatly after surgery)
- Ampliations(Inmediatly after surgery)
- Excision time(Inmediatly after surgery)
- Additional treatment interventions(3 weeks and 12 months after surgery)
- Postoperative complications(Inmediatly after surgery, 3 weeks and 12 months after surgery)
- Surgeon satisfaction(Inmediatly after surgery)