Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Tolerance to solid diet
研究概览
简要总结
Monocentric, two-level factorial, parallel-arm, pilot randomized clinical trial, conducted comparing patients undergoing laparoscopic right hemicolectomy with ICA for right colon cancer in a single unit of a teaching hospital: Minimally Invasive Surgery Unit, Department of Surgical Sciences, Policlinico Tor Vergata, Rome, Italy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Right colon cancer
- •Intracorporeal anastomosis
- •Laparoscopic surgery
- •Elective surgery
- •informed consent signed
排除标准
- •below 18 years old
- •Metastatic disease
- •Preoperative steroids
- •Conversion to open surgery
- •Emergency surgery
- •concomitant major operation
- •preoperative infective status
- •benign disease
研究组 & 干预措施
Abdominal drainage
19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter
干预措施: abdominal drainage (Procedure)
Abdominal drainage
19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter
干预措施: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC) (Procedure)
Abdominal drainage
19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter
干预措施: Laparoscopic standard D2 right hemicolectomy (STANDARD) (Procedure)
Postoperative antibiotico-prophylaxis
postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr
干预措施: Postoperative antibiotico-prophylaxis (Drug)
Postoperative antibiotico-prophylaxis
postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr
干预措施: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC) (Procedure)
Postoperative antibiotico-prophylaxis
postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr
干预措施: Laparoscopic standard D2 right hemicolectomy (STANDARD) (Procedure)
Control group
No drainage nor postoperative antibiotico-prophylaxis
干预措施: Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC) (Procedure)
Control group
No drainage nor postoperative antibiotico-prophylaxis
干预措施: Laparoscopic standard D2 right hemicolectomy (STANDARD) (Procedure)
结局指标
主要结局
Tolerance to solid diet
时间窗: 30 days postoperatively
time to light diet tolerance
次要结局
- White blood cell(30 days postoperatively)
- Mortality rate(90 days postoperatively)
- Procalcitonine(30 days postoperatively)
- Days of hospitalization(90 days postoperatively)
- Readmission rate(90 days postoperatively)
- Surgical site infection rate(30 days postoperatively)
- Anastomotic leak rate(30 days postoperatively)
- Tolerance to liquid diet(30 days postoperatively)
- Time to first flatus(30 days postoperatively)
- Time to first evacuation(30 days postoperatively)
- need of abdomen CTscan rate(30 days postoperatively)
- C-Reactive Proteine(30 days postoperatively)
研究者
Giuseppe Sigismondo Sica
Head of Minimally Invasive Surgery Unit
University of Rome Tor Vergata