Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers. A Randomized Multicentre Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 8
- 主要终点
- Anastomotic leakage rates differences between both groups at 30 postoperative days
研究概览
简要总结
Patients whom meet all eligibility criteria will be assigned random 1:1 to one of the following arms:
- ECPS group: Echelon Circular™ Powered Stapler (n=270)
- MCS Group: manual circular staplers (n=270) Patients will be followed during 30 days in order to evaluate the primary endpoint.
详细描述
Anastomotic Leakage (AL) is the complication that most concerns colorectal surgeons. It leads to prolonged postoperative stay, increased costs, risk of reoperations and a permanent colostomy, together with an increase in morbidity and mortality.
The novel Echelon Circular™ Powered Stapler (ECPS) (Ethicon, Somerville, NJ, USA), introduces design changes that could decrease the rate of technical errors and improve clinical outcomes. The powered stapler decreases the force needed on firing the device, improving stability at the anastomotic site. Atraumatic Gripping Surface Technology reduces the compressive forces on tissues, and along with 3D Stapling Technology allows a better compression distribution throughout the anastomosis and a better hemostasis.
This is a multicenter, randomized, open-label, controlled with parallel groups clinical trial, with 8 participant sites in total (4 sites in Spain and 4 sites in France), to include an approximate sample size (n) of 570 patients who will undergo a colorectal anastomosis after Hartmann reversal, left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology.
540 patients assigned randomly 1:1 to assess whether technical improvements of Echelon Circular™ Powered Stapler (ECPS) have an impact on left-sided colorectal Anastomotic Leakage (AL) rate compared to current manual circular staplers (MCS).
Anastomosis could be performed open, laparoscopically or with robotic assistance.
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
- 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
- •Patient or its legal representative informed consent.
- •Age ≥ 18 years.
- •Patients who will undergo a colorectal anastomosis after left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology (NOTE: Hartmann reversal cases also included).
排除标准
- •Diverting stoma.
- •Emergency surgery.
- •American Society of Anaesthesiologists (ASA) score ≥ IV.
- •Transanal total mesorectal excision approach.
研究组 & 干预措施
MCS Group
2-row circular staplers manual
干预措施: 2-row circular staplers manual (Device)
ECPS group
Echelon Circular™ Powered Stapler
干预措施: Echelon Circular™ Powered Stapler (Device)
结局指标
主要结局
Anastomotic leakage rates differences between both groups at 30 postoperative days
时间窗: Through study completion, an average of 1 year
To assess whether ECPS have an impact on left-sided colorectal AL rate compared to current manual circular staplers (MCS).
次要结局
- Morbidity differences between groups according to the Clavien-Dindo classification.(Through study completion, an average of 1 year)
- Postoperative endoluminal bleeding rate differences between both groups.(Through study completion, an average of 1 year)
- Re-intervention rate differences between both groups(Through study completion, an average of 1 year)