Surgical, Pathological and Oncological Outcomes of Laparoscopic Conventional Colectomy Versus Complete Mesocolic Excision for Operable Colon Cancer Cases in Upper Egypt
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Intraoperative vascular injury
研究概览
简要总结
The investigators will assess and compare Surgical, pathological and oncological outcomes between two laparoscopic procedures conventional colectomy versus complete mesocolic excision for operable colon cancer cases in Upper Egypt
详细描述
Colon cancer is considered a huge clinical surgical burden accounting for 10% of cancer cases and deaths all over the world with consideration that surgery and adjuvant chemotherapy(if indicated) are the main lines of treatment .
When Werner Hohenberger and colleagues described complete mesocolic excision (CME) in 2009; resection along the embryological and lymphovascular planes with appropriate resection margins, they did it for years before describing it with suggestion of improved disease outcomes and overall survival compared to the conventional colectomy (CC).
The principles of CME were described after the significant improvement of rectal adenocarcinoma surgical outcomes with establishment of total mesorectal excision (TME) in which tumor resection is associated with dissection of mesorectal fascial embryologic and lymphovascular planes.
CME includes the same principles of the CC with maximizing lymph node dissection level into (D3 extended lymphadenectomy instead of D1 and D2 in conventional colectomy) and central vascular ligation (CVL) of the main feeding vessel(s) at their origin, with suggested improved disease-free and overall survival with suggested superior pathological and oncological results in the specimen.
Some surgeons consider that CME; with D3 extended lymphadenectomy and CVL is the optimal or standard surgical method in primary cancer colon based on suggested reduced local recurrence and improved disease-free and overall survival.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes will be included.
- •Age: all adult patients.
- •All diagnosed patients with operable cancer colon.
- •Cancer at cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon.
- •Fit patients.
排除标准
- •Irresectable colon cancer.
- •Inoperable colon cancer.
- •Rectal cancer.
- •Unfit patients.
研究组 & 干预措施
Group A Operable colon cancer cases
All patients with operable colon cancer who will undergo laparoscopic conventional colectomy
干预措施: laparoscopic conventional colectomy (Procedure)
Group B Operable colon cancer cases
All patients with operable colon cancer who will undergo laparoscopic complete mesocolic excision
干预措施: laparoscopic complete mesocolic excision (Procedure)
结局指标
主要结局
Intraoperative vascular injury
时间窗: Intraoperative
Yes/No with measurement in Cubic Cm and how managed
Intraoperative blood loss
时间窗: Intraoperative
Yes/No with measurement in Cubic Cm
Amount of anastomotic leak
时间窗: within 4 weeks postoperative
Amount in cubic cm and nature of it with its management
Operative time
时间窗: Reporting immediately postoperative (at end of operation)
Reporting operative time with measurements in minutes
Postoperative lymph node status
时间窗: 2 weeks postoperative
Histopathological examination of the resected colon with lymph node status and number
Postoperative peritonitis
时间窗: 4 weeks postoperative
Cause and how to manage?
Colon cancer stage
时间窗: 2 weeks Preoperative
According to primary tumor, regional nodes, metastasis (TNM) staging system
length of resected mesocolon
时间窗: 2 weeks postoperative
In cm
Postoperative histopathological result
时间窗: 2 weeks postoperative
Type of the colon cancer
Occurence of anastomotic leak
时间窗: within 4 weeks postoperative
Yes/No
Carcinoembryonic antigen (CEA) level
时间窗: 2 weeks preoperative
Carcinoembryonic antigen (CEA) level by ng/mL
Intraoperative visceral injury type
时间窗: Intraoperative reporting
Yes/No and its type
Intraoperative visceral injury management
时间窗: Intraoperative reporting
How managed
Postoperative complications
时间窗: 4 weeks postoperative
Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System
Resection margins in postoperative histopathological status
时间窗: 2 weeks postoperative
Free or invaded
Postoperative faecal fistula
时间窗: 12 weeks postoperative
Reporting Yes/No with amount in cm3 and management
Urological complications
时间窗: Intraoperative and 4 weeks postoperative
Type and management
Type of anastomosis
时间窗: Intraoperative
Type of anastomosis (intra- or extracorporeal)
次要结局
- Wound dehiscence(4 weeks postoperative)
- Preoperative haemoglobin level(preoperative)
- Preoperative histopathological result(2 weeks preoperative)
- Neurological complications(4 weeks postoperative)
- Conversion to open surgery(intraoperative)
- Neoadjuvant therapy(2 weeks Preoperative)
- Average daily amount in intraperitoneal drain(2 weeks Postoperative)
- Postoperative ileus(2 weeks postoperative)
- Type of colonic anastomosis(Intraoperative)
- Cardiopulmonary complications(4 weeks postoperative)
- application of subcutaneous suction(1 week Postoperative)
- Age(preoperative)
- Site of cancer colon(2 weeks preoperative)
- Preoperative preparation(3 days Preoperative)
- Wound infection(2 weeks postoperative)
- Average daily amount in subcutaneous suction(2 weeks Postoperative)
- Preoperative colonoscopic examination result(2 weeks preoperative)
- Hospital stay(4 weeks postoperative)
研究者
Mostafa Farrag Mohammed
assistant lecturer of general surgery
Sohag University