A Novel Technique of Hand-assisted Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- operative time
研究概览
简要总结
The purpose of this study is to determine the short and long outcomes of the novel technique of hand-assisted laparoscopic right hemicolectomy with complete mesocolic excision and central vascular ligation for right colon cancer.
详细描述
Laparoscopic colectomy was first described by Jacobs in the early 1990s. Since then, as a minimally invasive approach, laparoscopic surgery has been gaining popularity for colorectal resection. Compared to open colectomy, laparoscopic colectomy has advantages in blood loss, recovery of bowel function, need for narcotic analgesics, and hospital stay. The long-term outcome of laparoscopic surgery for colon cancer has also been proved.
Complete mesocolic excision (CME) for colon cancer was reemphasized, with the merits of providing better cancer clearance and higher 5 year survival rate. Recently, it has been reported that patients with or without lymph node metastasis both benefit from a wider mesenteric excision including as many negative lymph nodes as possible. The use of D3 lymphadenectomy in colon cancer has been the state of art for decade in Asian countries. A comparison between Japanese D3 resection and European CME with central vascular ligation (CVL) showed that both series were oncologically superior to the traditional right hemicolectomy. Most recently, a consensus is reached between European and Japanese experts that a more radical approach combining CME and D3 lymphadenectomy are oncologically preferable.
Laparoscopic right hemicolectomy with CME or D3 lymphadenectomy have been reported to be feasible and safe by several authors. However, due to the notorious high rate of vascular variations in right colon, laparoscopic right-sided CME with CVL or D3 resection in obese patient remains challenging, even at experienced hands. Two of the major technical difficulties include the identifying of superior mesenteric vein (SMV) in thick layer of fatty tissue and dissection around the middle colic vessels. Here the investigators report a novel technique to tackle these two problems by combining transection of the bowels through the small incision and a medial to lateral approach of hand-assisted laparoscopic (HAL) surgery. The details are as followed:
Surgical Techniques Operation steps outside the abdominal cavity Under general anesthesia, the patient was placed in the supine position with legs split-ted. A middle incision about 7 centimeters long was made around the umbilicus, which was used for placing Lapdisc. This procedure started with transection of great omentum, transverse colon and the distal ileum through the self-expandible Lapdisc.
Transect transverse colon For cancer at ascending colon or cecum, the transverse colon should be divided at a site between the left and right branches of middle colic artery. For hepatic flexural or transverse colon cancer, the transverse colon should be divided at the left side of middle colic artery. After transverse colon was divided, the two ends of transverse colon were returned into the abdomen.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed right colon cancer
- •Clinical stage: I, II, III
- •No preoperative chemoradiotherapy
- •No past surgical history
- •No serious preoperative complication
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
- •Age: 18-80
- •Written informed consent
排除标准
- •Malignant neoplasm of other sites (including transverse, descending, sigmoid colon cancer, and rectal cancer)
- •Metastatic cancer
- •Multiple cancer
- •Serious complications (including bowel perforation, bowel obstruction, gastrointestinal hemorrhage)
- •Pregnant and lactating women
- •Psychological disorder
- •Steroid administration
- •Cardiac infarction within six months
- •Severe pulmonary emphysema and pulmonary fibrosis
研究组 & 干预措施
Group A
The novel hand-assisted laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were brought out through the hand-port incision at the beginning of the operation and divided extracorporeally.
干预措施: Group A (Procedure)
Group B
novel laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were divided at the beginning of the operation intracorporeally.
Group C
the traditional laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer.
结局指标
主要结局
operative time
时间窗: 1 day
the content RNA of CEA and CK20 in circulating tumor cells and ascites
时间窗: 1 week
次要结局
- postoperative complications(1 year)
- overall survival(3 years)
- 3-year local recurrence(3 years)
- disease-free survival(3 years)
研究者
Ziqiang Wang,MD
Chief of Department of Gastrointestinal Surgery
West China Hospital
