Prospective Registration Study of Totally Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Incidence of postoperative complications
研究概览
简要总结
This is a comparison of totally laparoscopic and laparoscopic-assisted colon cancer resection, a prospective registration study comparing the safety and benefits of the two operations
详细描述
Colorectal cancer is one of the most common malignant tumors in China. With the advancement of medical science and technology, the treatment of colorectal cancer has become more mature, forming a comprehensive and individualized treatment model focusing on surgery. The promotion of the principles of TME and CME surgery has greatly standardized the operation of colorectal surgery. COLOR II, COREAN and CLASICC studies have all confirmed the safety and effectiveness of laparoscopic colorectal cancer surgery.
In traditional laparoscopic-assisted surgery, a small incision in the abdominal wall is used to assist in trimming the mesangium to remove the specimen, and the anastomosis is completed outside the abdominal wall, which will still cause postoperative incision pain and may lead to complications such as incisional infection and incisional hernia. However, in some obese patients, the mesangium is thick and short. The above operations are more difficult, and may even cause the risk of mesangial tears and bleeding, which will weaken the minimally invasive advantages of laparoscopic surgery.
The total laparoscopic radical resection of colon cancer is performed under laparoscopic free dissection and dissected reconstruction of the operation area. The small incision of the abdominal wall Trocar is used to take out the specimen, which not only guarantees a sufficient range of dissection and resection, but also avoids the troubles caused by the auxiliary abdominal wall incision. Postoperative recovery may be faster, but it also raises questions about the increased risk of infection in the surgical area. Total laparoscopic radical resection of colon cancer still lacks corresponding high-quality clinical research. In response to this problem, this study compares related surgical methods, verifies the safety and effectiveness of the corresponding surgical methods, and provides better guidance for subsequent clinical practice.
Taking laparoscopic-assisted radical resection of colon cancer as a control, the short-term and long-term effects of full laparoscopic radical resection of colon cancer were evaluated, so as to choose a more effective and safe operation method.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years old, male or female;
- •Colon cancer (ascending colon, transverse colon, descending colon, sigmoid colon) is diagnosed by histology or cytology;
- •The clinical stage is T1-4aN0-2M0; 4 No multiple distant metastases;
- •ECOG score 0-2;
- •Heart, lung, liver, and kidney functions can tolerate surgery;
- •Patients and their families can understand and are willing to participate in this clinical study, and sign an informed consent.
排除标准
- •Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
- •Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
- •Neighboring organs need to be combined with organ resection;
- •New adjuvant therapy before surgery;
- •ASA grade ≥ grade IV and/or ECOG physical status score> 2 points;
- •Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
- •History of severe mental illness;
- •Pregnant or lactating women;
- •Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.
结局指标
主要结局
Incidence of postoperative complications
时间窗: 30 days after operation
Complication incidence 30 days after operation
次要结局
- 5-year overall survival OS(5 years after operation)
- Rate of complete mesentery resection (CME)(one week after surgery)
- Operation time(one hour after surgery)
- Postoperative recovery(During the postoperative hospital stay)
- Length of surgical incision(one week after surgery)
- 3-year disease-free survival(3 years after operation)
- number of lymphnodes dissected(During the operation)
- Intraoperative blood loss(one hour after surgery)
- Intraoperative conversion rate(one hour after surgery)
研究者
Quan Wang
Professor
The First Hospital of Jilin University