Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Evaluation of the circumferential margin status in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)
研究概览
简要总结
Elaboration of a preoperative prediction model of the quality of the mesorectum and the involvement of the circumferential margin in patients with mid-low rectal cancer who undergo laparoscopic anterior rectal resection.
In a second phase the investigators will study the utility of the prediction model in classifying patients with high risk of suboptimal quality of mesorectum and/or positive circumferential margin. Patients with high preoperative risk will undergo a transanal total mesorectal excision and patients with low risk a laparoscopic transabdominal mesorectal excision. The investigators finally will compare pathological outcomes ( quality of mesorectum and circumferential margin), survival and recurrence between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients directed to laparoscopic anterior rectal resection through a transabdominal or a transanal approach.
- •Age ≥ 18 years
- •Histology of adenocarcinoma or adenoma
- •With or without neoadjuvant chemoradiotherapy
- •TNM classification: T2 or T3, any N stage or M stage
- •Intention of resection R0
排除标准
- •TNM classification: T1 or T
- •Complicated rectal cancer or emergency surgery.
- •Previous major colorectal surgery
结局指标
主要结局
Evaluation of the circumferential margin status in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)
时间窗: 30 days
Evaluation of the circumferential margin status (positive or negative) in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)
Evaluation of the quality of mesorectum in the rectal specimen according to international consensus (goog quality, moderate quality and poor quality)
时间窗: 30 days
Evaluation of the quality of mesorectum as optimal or suboptimal (international consensus defines three grades of resection: Group 1: including mesorectal resection, good quality Group 2: intramesorectal resection: moderate quality Group 3: resection in the muscularis propria, poor quality). Investigators will group patients into two groups: optimal mesorectum (group 1) and suboptimal mesorectum (group 2-3).
次要结局
- Survival(2 years)
- Recurrence(2 years)
研究者
Pere Planellas Giné
MD PhD
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta