INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer: a Randomized Clinical Trial. (IN EXTREMO Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 384
- 试验地点
- 2
- 主要终点
- Overall surgical morbidity
研究概览
简要总结
The aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal anastomosis (EA) after laparoscopic right hemicolectomy for cancer.
详细描述
Background. Only a few retrospective publications comparing these anastomotic techniques and no randomized clinical trial has been performed. We conducted a meta-analysis of the existing non randomized comparative studies on the argument: the results suggest that the IA results in better postoperative recovery outcomes, such as shorter hospital stay, faster bowel movement recovery, faster first flatus, faster time to solid diet and lesser analgesic usage.
Design: Two-armed, double-blinded, randomized, controlled study.
The patients will be randomized into two groups:
A. After laparoscopic right colectomy for cancer, anastomosis will be carried out intracorporeally (IA) B. After laparoscopic right colectomy for cancer, anastomosis will be carried out extracorporeally (EA)
Primary endpoint: Surgical morbidity rate defined as any diagnosed morbidity related to surgical technique (anastomotic leakage, anastomotic bleeding, wound infection, ileus) within 60 days from surgery.
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
- Double (Participant, Outcomes Assessor)
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
- •Patients suitable for curative surgery 18-80 years old
- •ASA grade I-III
- •Histhopatological confirmed right only colon carcinoma.
- •Elective interventions
- •Laparoscopic surgery
- •Informed consent
排除标准
- •Informed consent refusal
- •Metastatic disease
- •Not right colon cancer
- •Non elective procedure
- •Open or converted operations
结局指标
主要结局
Overall surgical morbidity
时间窗: 60 days from surgery
Surgical morbidity rate defined as any diagnosed morbidity related to surgical technique (anastomotic leakage, anastomotic bleeding, wound infection, ileus) within 60 days from surgery.
次要结局
- Operative time(day of intervention)
- Largest incision length(day of intervention)
- Numbers of node harvested(day of intervention)
- Intraoperative complicatons(day of intervention)
- Mortality(60 days from surgery)
- Non surgical site complications(60 days from surgery)
- Bowel movement(10 days from surgery)
- First flatus(10 days from surgery)
- First stool canalization(10 days from surgery)
- Time to solid diet(10 days from surgery)
- Naso gastric tube reintroduction(60 days from surgery)
- Days of analgesic usage(60 days from surgery)
- Length of hospital stay(60 days from surgery)
- Readmission(60 day from intervention)
研究者
Marco Scatizzi
MD
Ospedale Misericordia e Dolce