Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer - A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Overall complication rate
研究概览
简要总结
In this study, the investigators will compare extracorporeal anastomosis (EA) with intracorporeal anastomosis (IA) in patients undergoing elective laparoscopic hemicolectomy for right colon cancer.
详细描述
At Odense University Hospital, Svendborg, current standard treatment for right colon cancer is laparoscopic hemicolectomy with extracorporeal anastomosis (EA).
To reduce the risk of adverse events, such as fascial dehiscence and later development of incisional hernia, right hemicolectomy with intracorporeal anastomosis has been introduced.
When performing a laparoscopic right hemicolectomy the dissection is carried out intracorporeally and the transection and anastomosis is made extracorporeally (EA technique). For IA technique the cancer bearing segment is resected and the bowel ends joined intracorporeally with laparoscopic technique, and the specimen is then retrieved through a Pfannenstiel incision.
Previous series have shown shorter hospital stay as well as shorter time to bowel recovery in patients treated with IA compared to EA, without increasing the risk of severe complications or compromising the oncological outcome.
The aim of this study is to investigate whether IA in patients undergoing right hemicolectomy reduces the overall complication rate compared to EA evaluated by Comprehensive Complication Index (CCI) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Patients diagnosed with right colon cancer
- •Eligible for elective laparoscopic right hemicolectomy with primary anastomosis.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •CT staged T1-T3M0 tumour.
排除标准
- •Pregnancy
- •Mental incompetence
- •Acute right hemicolectomy before the intended elective surgery
结局指标
主要结局
Overall complication rate
时间窗: 30 days
According to the Comprehensive Complication Index (CCI) based on the Clavien Dindo classification of postsurgical complications. CCI is a continuous scale from 0-100 (0 equals no complications, 100 equals death)
次要结局
- Length of hospital stay(Up to 30 days)
- Time until bowel recovery(Up to 30 days)
- Surgical stress response(Up to 30 days)
- Postoperative pain(Up to 30 days)
- Hernia rate(3 years)
研究者
Benedicte Schelde-Olesen
Principal investigator
University of Southern Denmark