Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 21
- 主要终点
- Change in Stoma creation rate
研究概览
简要总结
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
详细描述
A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Today a stoma is created for all high-risk patients even though the expected anastomotic leak rate is less than 20%. This means that 80% of patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.
CG-100, a removable, temporary intraluminal bypass device, developed by Colospan, is designed to address this need by safely postponing the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis); thereby allowing patients with an intact anastomosis a quicker and safer return to normal activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is willing to comply with protocol-specified follow-up evaluations
- •Patient 22-65 years of age at screening, or patient 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.
- •Patient is diagnosed with colorectal cancer
- •Patient is scheduled for elective either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis, maximally 10 cm from the anal verge
- •Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation.
- •Patient is scheduled to undergo mechanical bowel preparation
- •The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).
排除标准
- •Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
- •Major surgical or interventional procedures within 45 days prior to this study or planned surgical or interventional procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter stent insertion).
- •Patients with ASA classification > 3
- •Albumin < 30 g/liter
- •Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
- •Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression
- •Patient is going through another surgical procedure (other than ileostomy, adhesiolysis) during the surgery.
- •The patient is currently participating in another investigational drug or device study unless pre-approved by the sponsor.
- •Patient has been taking regular systemic/ steroid medication in the last 6 months.
- •Patients is taking antimetabolites or antiplatelet agents.
- •Patient has preexisting sphincter problems
- •Patient has evidence of extensive local disease in the pelvis or has undergone a prior pelvic anastomosis.
- •Patients with massive diverticulosis at the sigmoid/descending colon (viewed on preoperative CT)
- •Any condition or abnormality which in the opinion of the investigator may jeopardize the patient's safe participation or the quality of the data
- •Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.
研究组 & 干预措施
CG-100
Patients receive CG-100 during rectal cancer surgery
干预措施: CG-100 intraluminal bypass device (Device)
SOC
Patients receive a protective stoma during rectal cancer surgery
干预措施: Stoma (Procedure)
结局指标
主要结局
Change in Stoma creation rate
时间窗: 39 Weeks
Incidence of complications
时间窗: 39 Weeks
次要结局
未报告次要终点