Long-term Clinical Results and Direct Economic Implication Within the Randomized Clinical Trial Comparing Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA) compared to extracorporeal anastomosis (EA) are widely studied. Nowadays we can conclude, with a high level of scientific evidence, that there are a number of short-term clinical advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA).
However, there is currently no randomized studies describing long-term clinical and oncological outcomes.
详细描述
Background:
Little evidence has been published demonstrating the advantages of IA versus EA.
Recent publications show the superiority of IA in terms of early functional digestive recovery, a shorter surgical incision, a lower need for analgesia, lower blood loss, and lower postoperative Clavien-Dindo grade. These results are similar to other further published studies, including multicenter randomized clinical trials and meta-analyses.
Methods:
This is a a long-term clinical follow-up study of 140 patients included preaviously in the single-blind single-center randomized prospective clinical trial conducted at the Hospital de la Santa Creu i Sant Pau (HSCSP) between 2015-2018; in which 30-day clinical outcomes after laparoscopic right colectomy for colon cancer with IA vs EA anastomosis were compared.
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
- Single (Participant)
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
- •Neoplasms settled in the cecum, right colon, hepatic flexure or proximal transverse colon
- •Surgical procedure with curative purpose.
- •American Society of Anaesthesiologists Physical Status (ASA) I, II and III.
- •Elective surgery.
- •Signed Informed Consent.
排除标准
- •Denial of informed consent.
- •Advanced neoplasia (Stage IV)
- •Urgent surgery.
- •Bening colonic disease, such Ulcerative Colitis or Crohn Disease
- •Multivisceral procedures performed
研究组 & 干预措施
Intracorporeal anastomosis (IA)
Experimental: Intracorporeal anastomosis Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen is retrieved through a Pfannenstiel incision.
干预措施: Intracorporeal anastomosis (Procedure)
Extracorporeal anastomosis (EA)
A transverse incision in the right upper quadrant is performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Rel Stapler
干预措施: Extracorporeal anastomosis (Procedure)
结局指标
主要结局
Overall survival
时间窗: 3 years
Percentage of patients alive after a 3-years follow-up-period since the laparoscopic right colectomy is performed
次要结局
- Disease-free survival(3 years)
- Local recurrence(3 years)
- Distant recurrence(3 years)
- Incisional hernia(3 years)
- Intestinal obstruction(3 years)
- Cost of surgical material(Intraoperative time)
- Cost of operative room(Intraoperative time)
- Cost per global hospitalization(Time from the first day of operation until the day that the patient is discharged from the hospital)
- Cost per ICU hospitalization(Time from the first day of entry into ICU until the day that the patient is transfered to Surgery Department)
- Cost of tests during hospitalization(Time from the first day of operation until the day that the patient is discharged from the hospital)