Comparison of Laparoscopic Versus Open Right Colectomy for Right Colon Cancer, According to the Complete Mesocolic Excision (CME) Principles: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Mesocolic Resection Plane
研究概览
简要总结
The purpose of this research protocol is to compare open versus laparoscopic right colectomy (according to the CME technique of complete mesocolic excision) for right colon cancer. This study will be designed as a prospective randomized controlled trial. The comparison of the two techniques will include endpoints regarding the quality characteristics of the specimens and the oncological results. In addition, the effectiveness of the two methods will be evaluated in terms of the early and late postoperative period.
详细描述
Colorectal cancer is the third and second most common malignancy in male and female patients, respectively, with up to 1.8 million new cases and 860,000 deaths per year.
Anterior resection with total mesorectal excision (TME) was first proposed by Heald in 1982 and is currently the gold standard surgical technique for middle and lower rectal cancer. Heald considered that the metastatic spread of the tumor occurs through micro-implantations in the lymph node network of the mesorectum, and much less through horizontal intramural infiltration, and thus defined rectal resection margins at 5cm or even 2cm for well-differentiated neoplasms. Therefore, he suggested that mesorectum displays a greater risk for micro-metastatic disease and should be removed en-bloc with intact resection margins.
Similarly in 2009, Hohenberger proposed the complete mesocolon excision (CME) concept for the treatment of colon cancer, based on the respective embryological development anatomical planes. After analyzing a large cohort of patients, he concluded that this operation type leads to a significant reduction in the local recurrence and an increase in the overall survival rates.
Hohenberger proposed open CME as the optimal surgical technique for colon cancer, under the premise that the following principles are met:
- Dissection of Toldt's fascia and mesocolon preservation
- Central vascular ligation
- Extensive locoregional lymph node dissection CME technique, as described by Hohenberger in 2008, is an extension of Heald's TME and it is based on the sharp dissection and separation of the visceral fascia that surrounds the colon from the parietal fascia. The aim is to fully mobilize the colon and the corresponding mesocolon, which is surrounded bilaterally by sheets of visceral fascia. This ensures the complete resection of the tumor and the corresponding lymph nodes. At the same time, central vascular ligation allows the dissection of the apical lymph nodes.
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
盲法说明
There will be no blindness at the level of the patient, the treating physicians (surgeon, anesthesiologist) and the researcher who will record the data.
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
- •Histologically confirmed right colon cancer (cecum, ascending colon, hepatic flexure)
- •Surgical resection based on the CME principles
- •Patient 18 to 90 years old
- •American Society of Anesthesiologists score ≤III
- •Elective operation
- •Signed informed consent of the patient
排除标准
- •Non elective operation (hemorrhage, perforation, obstruction)
- •Locally advanced disease (T4)
- •Distant metastases (Stage IV)
- •American Society of Anesthesiologists ≥IV
- •Previous laparotomy
- •BMI >35 kg/m2
- •Active sepsis or systemic infection
- •Untreated physical and mental disability
- •Pregnancy or breast-feeding
- •Lack of compliance with the protocol process
- •Non-granting of signed informed consent
研究组 & 干预措施
Laparoscopic right colectomy
In laparoscopic right colectomy subgroup, the patient will be placed in a lithotomy position. Entrance in the peritoneal cavity will be completed via the open Hasson method. Overall, 4 ports will be used: 10mm at the umbilicus for optical entry, 12mm in the left midclavicular line below the umbilicus as the main working port, 5mm at the McBurney point, and 5mm between the umbilicus and the xiphoid process. Dissection of the peritoneal fold, under the terminal ileum, will be performed based on the medial to lateral approach. Similar to the open approach, the ileocolic vessels, as well as the right branches of the middle colic will be ligated at their origin for cecal and proximal ascending tumors. For hepatic flexure cancers, the medial colic vessels will be ligated. The ileocolic anastomosis will be completed either intracorporeally or extracorporeally, using staples or sutures.
干预措施: Laparoscopic right colectomy (Procedure)
Open right colectomy
In the open right colectomy group, the operation will start with a midline incision and dissection based on the lateral to medial approach. The lateral peritoneal fold along Toldt's line will be incised and the ascending colon will be mobilized from the retroperitoneum according to the embryological dissection planes. Dissection will continue until the anterior surface of the superior mesenteric vessels at the third duodenal part. Ileocolic and right colic vessels will be ligated at their origins. For hepatic flexure tumors, the middle colic vessels will be also ligated at their origin. The ileocolic anastomosis will be performed using an automatic stapler. The anastomosis will be completed either with staples or sutures.
干预措施: Open right colectomy (Procedure)
结局指标
主要结局
Mesocolic Resection Plane
时间窗: 1 month postoperatively
Occurrence of Mesocolic Resection Plane. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
次要结局
- Postoperative Complication(1 month postoperatively)
- Operative Time(Intraoperative period)
- Bowel Function Recovery(7 days postoperatively)
- Open Conversion(Intraoperative period)
- Type of Anastomosis(Intraoperative period)
- Intraoperative Transfusion(Intraoperative period)
- Negative Resection Margin(1 month postoperatively)
- Disease Free Survival(5 years postoperatively)
- Overall Survival(5 years postoperatively)
- Length of Hospital Stay(Maximum time frame 39 days postoperatively])
- Local Recurrence(5 years postoperatively)
研究者
Perivoliotis Konstantinos
Perivoliotis Konstantinos, Principal Investigator
Larissa University Hospital