The Comparison Between Traditional Laparoscopy-assisted Surgery and Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery，NOSES) in Radical Resection of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- the incidence of complications
研究概览
简要总结
This study is to compare the short-term and long-term outcomes of traditional laparoscopy-assisted surgery and total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES) for colorectal cancer and to find a better surgical method for patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cases should be diagnosed as rectal or sigmoid colon cancer by histology or cytology. The tumor is 5-20cm from the pectinate line. The clinical stage is T1-2, N0, M0 for rectal cancer and T1-T3, N0-2, M0 for sigmoid colon cancer.
- •Eastern Cooperative Oncology Group (ECOG) scale 0-2
- •Heart, lung, liver, and kidney function can tolerate operation
- •Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.
排除标准
- •history of colorectal malignant disease
- •recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin)
- •patients with intestinal obstruction, intestinal perforation, bleeding requiring emergency surgery
- •a history of abdominal surgery (which makes it difficult to perform laparoscopic procedures), severe systemic disease such as diabetes, severe chronic lung disease, cirrhosis, other malignant diseases
- •combined colorectal multiple carcinomas
- •poor anal function before operation and incontinence of defecation
- •with a history of serious mental illness
- •pregnant or lactating women
- •The researchers believe that the patients are unsuitable to participate in the researchers with other cases. A patient or family refusal to join
研究组 & 干预措施
traditional laparoscopy-assisted surgery
The traditional laparoscopic operation undergo and then a small incision(5cm) is made in the middle of the lower abdominal wall to trim the mesangial membrane and remove the specimen. At last the anastomosis operation undergo by the laparoscopic operation.
干预措施: traditional laparoscopy-assisted surgery (Procedure)
total laparoscopic surgery with no incision (NOSES)
The whole procedures undergo by total laparoscopic surgery with no incision in the abdominal wall. The specimen then will be removed through natural orifice such as anal.
干预措施: total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES) (Procedure)
结局指标
主要结局
the incidence of complications
时间窗: one month after surgery
All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification.The classification mainly focuses on the medical perspective, with major emphasis on the risk and invasiveness of the therapy used to correct a complication. From light to heavy, it consists of five grades (Ⅰ to Ⅴ)
次要结局
- the operation time(in the perioperative period)
- the blood loss during the operation(in the perioperative period)
- Postoperative recovery of intestinal peristalsis(in the perioperative period)
- Visual Analogue Scale/Score(in the perioperative period)
- the functional outcome of defecation, if there is incontinence(Three months after operation)
- 3-year disease-free survival(three years after operation)
- The mean postoperative hospital stay(in the perioperative period)
- cases converted to laparotomy(in the perioperative period)
研究者
Dong Yang
doctor
Jilin University