NCT00559013已完成不适用
Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.
研究概览
简要总结
Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.
详细描述
Study is designed as a prospective enrollment of patients undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. Patients who are scheduled for elective resection of the left, anterior and low anterior colon can be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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 must comply with follow-up evaluations
- •Patient or representative must provide informed consent prior to enrollment
- •Patient scheduled for elective surgical excision of the left, anterior or low anterior colon
- •Patient must meet all criteria and be eligible to have open or laparoscopic colorectal surgery with primary anastomosis at one location
排除标准
- •Crohns disease
- •Emergency colorectal surgery for trauma, obstruction, ischemic bowel, perforated diverticulum and all other emergent diagnosis.
- •Patients who have not had mechanical bowel preparation
- •Patients with known documented sensitivity/allergy to bovine material
- •Severe radiation damage to tissue
- •Carcinomatosis or stage IV cancer
- •BMI is 35 or greater
- •Cancer at primary anastomosis site that cannot be excised
- •Patients who require an ileo rectal anastomosis
- •Surgery anticipated to include jejunostomy pouch
- •Anticipated diverting stoma
- •No anti adhesive barrier can be used around anastomotic site
- •No multiple circular anastomosis
- •Surgeons discretion to exclude any patient he/she feels would not have a safe anastomosis
- •Patient life expectacny less than follow-up timeframe of study
- •Pregnancy
- •Patients currently enrolled in a study that competes for the same patient population
结局指标
主要结局
Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.
时间窗: Discharge and 1 Month post surgery
次要结局
未报告次要终点
研究者
研究点 (4)
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