Clinical Validation of C-REX Device for Adaptive Anastomoses: A Multicentre Non-Randomised Controlled Study for Post-Market Clinical Follow-up
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Incidence rate of radiologically verified clinical anastomotic leakage related to the investigational device(s).
研究概览
简要总结
In colorectal surgery, hand suturing and stapling are routine methods for performing intestinal anastomoses, and these methods appear to be similar in terms of clinical safety. Despite several years of experience with surgical procedures as well as improvements to the medical devices, problems with disturbed anastomotic healing leading to leakage and stenosis after colorectal surgery remain a significant challenge for surgeons. A frequency of anastomotic leakage after stapling or suturing has been reported to range from 3% to 20%. In addition, preoperative radiotherapy has been shown to increase the risk of anastomotic leakage even further.
The methods that are used today to detect leakages are unfortunately inaccurately and limited to monitoring symptoms, temperature, CRP-levels, and performing abdominal examinations and CT-scans. These clinical signs and parameters usually become apparent several days after onset of the leakage, which leads to a delayed diagnosis. Anastomotic leakage is not only a significant cause of increased morbidity of complications and mortality in patients, but also associated with increased risk of local recurrence and poor prognosis. Moreover, when reoperation is required to fix the leakage, a permanent stoma may be made at the level of the sigmoid colon and this procedure impacts live quality of patients negatively.
Based on the above considerations, a novel, adaptive anastomotic method has been developed by CarpoNovum to achieve a safer anastomosis. The method's working name is C-REX Ring-locking Procedure. C-REX is referred to our Colorectal anastomotic rings for Re-join the intestinal ends and validate the anastomosis, with function of Extract samples for analysis and conduct X-ray through connected catheters.
The newly developed adaptive anastomotic medical devices, C-REX LapAid Cath and C-REX RectoAid Cath are easy to use, with unique possibility to control the anastomosis during and after surgery. The previous successful pre-market data support a successful CE marking of the devices, which encourages a post-market clinical follow-up (post CE mark clinical study) in patients undergoing colonic resection to collect post-market data of C-REX LapAid Cath and C-REX RectoAid Cath for the purpose of clinical evaluation and risk analysis.
详细描述
OVERALL DESIGN:
The study is a post-market multicentre non-randomized controlled study. In each investigational site, the investigational personnel shall start with colonic resections, first 10 patients. When surgeons feel confident using the device and ward personal feel confident treating the patient postoperatively, they will initiate rectal resections.
Eligible patients for C-REX LapAid Cath are those requiring resection of the left colon (descending colon and sigmoid) or above the upper rectum (> 15 cm above the anal rim) due to malign or benign disease. Eligible patients for C-REX RectoAid Cath are those requiring resection of the rectum due to malign or benign disease. The proximal limit is upper rectum (< 15 cm above the anal rim) and the distal limit is the anal sphincter.
Patients will be enrolled in the study after they have provided informed consent, having undergone physical examination and been found to meet inclusion criteria. Bowel cleansing prior surgery should be performed according to local routines. The intestinal resection and anastomosis with the investigational devices, i.e. C-REX LapAid Cath or C-REX RectoAid Cath, shall be performed in line with standard procedure of proctocolectomy during hospitalization. Surgeons can utilize catheters that allow monitoring of the anastomosis during and after surgery.
The healing period is expected to be approximately 10 ± 2 days. The short-term implant detaches via necrosis on the inner part of the intestinal surface and is expelled the natural way. The patient can be discharged before expelling of the short-term implant upon investigator's discretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female age ≥ 18 years old.
- •Planned resection due to benign or malign disease in the left colon or the rectum.
- •Cognitive ability to take part in the study and understand the information the patient receives about participating in the study and provide informed consent.
排除标准
- •Pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia.
- •Non-curable metastatic disease (cancer with multi-organ metastases).
- •Intestinal or anal stenosis or other obstructions distal to the anastomotic site.
- •Contraindications to general anaesthesia.
- •Other conditions upon surgeon's discretion that may warrant exclusion.
结局指标
主要结局
Incidence rate of radiologically verified clinical anastomotic leakage related to the investigational device(s).
时间窗: Up to 30 days after surgery
Anastomotic leakage is defined as a defect in the intestinal wall at the site of the anastomosis (including C-REX short-term implants) which leads to a communication between the intra- and extraluminal spaces. The severity of anastomotic leakage should be classified according to the clinically required measures. Grade A anastomosis leakage does not lead to any change in the researcher's handling, while Grade B leakage requires active therapeutic intervention but is manageable without relaparotomy. Grade C anastomotic leakage requires relaparotomy.
次要结局
- Duration of surgery(During surgery)
- C-REX integrity pressure test (optional)(During surgery)
- Time to evacuation of the short-term implant(About 10 ± 2 days after surgery)
- Healthcare utilization patterns assessment(At 12 months post-surgery)
- Postoperative complication assessment(Up to 30 days after surgery)
- Air leak test during surgery(During surgery)
- Incidence rate of investigational device(s) related adverse event (AE) and serious adverse event (SAE) other than anastomotic leakage(Up to 12 months after surgery)
- Postoperative bowel dysfunction assessment(At 12 months post-surgery)