An Open, Single-arm, Single Center, Clinical Trial to Investigate the Feasibility and Safety of Laparoscopic Ileocecus-sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1-year local recurrence
研究概览
简要总结
To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe
详细描述
Our study is a single arm, single center clinical trial. The enrolled patients will accept laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative complications, 1-year local recurrence. The second endpoint: conversion to conventional right hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year disease free survival, R0 resection, Specimen morphometry
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suitable for curative surgery 18-75years old
- •ASA grade I-III
- •Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
- •Localization diagnosis: the tumor located at hepatic flexure and proximal transverse colon(proximal to the right branch of middle colic artery);
- •Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T1-T4N0 or TanyN+; there is no distant metastasis.
- •Intraoperative measurement: the distance between colic branch of ileocolic artery and proximal edge of the tumor should be longer than 5cm.
- •Informed consent
排除标准
- •Simultaneous or metachronous multiple primary colorectal cancer;
- •History of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
- •Preoperative imaging examination results show: fused lymph node at the root of ileocolic artery.
- •Distant metastasis.
- •History of any other malignant tumor in recent 5 years.
- •Patients need emergency operation.
- •Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
- •Informed consent refusal
结局指标
主要结局
1-year local recurrence
时间窗: 7 days after surgery
rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein,
Postoperative complications
时间窗: up to 90 days after surgery
Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded
次要结局
- R0 resection(up to 1 week after surgery)
- Specimen morphometry(within 30 days)
- 3-year disease free survival(3 years)
- Conversion to conventional right hemicolectomy(1 day of surgery)
- Time to first flatus after surgery(up to 7 days after surgery)
- Number of harvested lymph nodes(up to 1 week after surgery)
研究者
Ding Ke-Feng
Professor
Zhejiang University