A Prospective, Non-randomized Multicenter Study Verifying C-REX LapAid and C-REX DMH/DMHC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to evacuation of the short-term implant
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. 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 (C-reactive protein)-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 quality of life 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 novel adaptive anastomotic medical devices, C-REX LapAid and C-REX DMH/DMHC are easy to use, with unique possibility to control the anastomosis during and after surgery. The previous successful preclinical study encourages a clinical verification in patients undergoing colonic resection to evaluate the safety and performance of C-REX Ring-locking Procedure by use of C-REX LapAid and C-REX DMH/DMHC.
详细描述
OVERALL DESIGN The study is a prospective, multicenter, single arm study Possible study candidates are patients requiring resection of the left colon (descending colon and sigmoid) or the upper rectum (15cm above the anal rim) due to malign or benign disease. After physical examination, checking of inclusion/exclusion criteria, and after informed consent has been achieved, potential subjects will be enrolled in the study, and the investigational surgery will be performed during hospitalization. The devices, i.e. C-REX LapAid and C-REX DMH/DMHC (dual male handle/dual male catheter handle), included in C-REX Ring-locking Procedure are applied to the inside of the intestine and connected to catheters that allow monitoring of the anastomosis (if DMC is applied).
The healing period is expected to be approximately 10 ± 2 days. The short-term implant, i.e. the anastomotic ring, detaches via necrosis on the inner part of the intestinal surface and is expelled the natural way during hospitalization.
The subject can be discharged from the hospital when the short-term implant has been evacuated, and the subject has begun to eat and has normal bowel movements. The observation period lasts until 30 days after surgery. The subject then continues follow-up according to local routine.
QUALITY CONTROL Authorization to perform C-REX Ring-locking Procedure According to CarpoNovum's regulation (Document 0041: Procedure, Accreditation of Surgeons for Clinical Studies), clinical investigators must be authorized to conduct the C-REX Ring-locking Procedure with C-REX LapAid and C-REX DMH/DMHC by performing at least one surgery on pigs and at least one train-in surgery on patients with the person in charge of the study (Dr. Anders Grönberg). When the clinical investigator is authorized to perform the C-REX Ring-locking Procedure with C-REX LapAid System, he or she receives a certificate. This certificate could also admit the clinical investigator the right to authorize other surgeons to perform C-REX Ring-locking Procedure with C-REX LapAid and C-REX DMH/DMHC (i.e. to perform at least one operations on pigs and at least one train-in operations on patients with the authorized clinical investigator).
Monitoring To ensure that the study is appropriately conducted, a monitor appointed by the sponsor will visit the investigation site regularly and oversee the investigator's compliance with the CIP, perform source-data verification and report to the sponsor on the progress of 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age ≥ 18 years and ≤ 70 years.
- •Planned resection due to benign or malign disease in the left colon (descending colon and sigmoid) or the upper rectum (15 cm above the anal rim).
- •Cognitive ability to take part in the study and understand the information he/she receives about participating in the study.
- •Sign the informed consent form.
排除标准
- •Urgent medical condition requiring immediate care.
- •Current surgical conditions, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, intestinal ischemia or dissemination (metastases) of cancer.
- •Stenosis or other obstructions in the anal passage.
- •Previous major abdominal surgery, previous radiation therapy to organs in abdomen or pelvis.
- •Health condition classified as ASA (American Society of Anesthesiologists) score III - VI.
- •Albumin level less than 35 g/l.
- •Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease).
- •Disease that requires more than one anastomosis during the surgical procedure.
- •Treatment with cortisone and/or other immunosuppressive medications less than one month before surgery.
- •Contraindications to general anesthesia.
- •Perioperative detection of extreme variants of intestinal diameters or wall thickness.
- •Cognitive ability that limits the patient's ability to take part in the study and understand the information he/she received about participating in the study, or the patient does not agree to join the study.
- •Heart attack ≤ 6 months or sever heart disease.
- •Severe embolic disease.
- •Other conditions which surgeons think the patient should be excluded. -
研究组 & 干预措施
C-REX group
After resection of the disease in colon, the intestinal ends will be anastomosed by the investigational device, i.e. C-REX LapAid and C-REX DMH/DMHC included in the C-REX Ring-locking Procedure.
干预措施: C-REX Ring-locking Procedure (Device)
结局指标
主要结局
Time to evacuation of the short-term implant
时间窗: About 2 weeks after surgery
The subject informs the clinical investigator and hand over the expelled short-term implant
次要结局
- Time to first intestinal sounds(Up to 30 days after surgery)
- Number of postoperative interventions related to the device(Up to 30 days after surgery)
- Integrity pressure(The operation day)
- Time to first defecation(Up to 30 days after surgery)
- Time to first passage of gas(Up to 30 days after surgery)
- Post-operative X-ray examination(Up to 4 days after surgery)
- Time of surgery(The operation day)