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临床试验/NCT01451008
NCT01451008已完成1 期

Safety Study of Compression Anastomotic Ring-locking Procedure (CARP) in Patients Undergoing Colonic Resection

Region Skane2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
Region Skane
入组人数
25
试验地点
2
主要终点
Complications, including anastomotic leakage, problems with ring evacuation

研究概览

简要总结

The intestinal ends must be rejoined after colonic resection. Conventional methods include sutured and stapled anastomoses, which is associated with 3-6% leakage after colonic surgery. The leakage of an anastomosis can cause serious consequences, such as abdominal infections and/or sepsis. Early detection of anastomotic leakage is the best way to avoid serious abdominal infections. The methods that are used today to detect leaks are unfortunately not very accurate. These methods include monitoring symptoms, temperature, and CRP-levels, and performing abdominal examinations and tomography scans. Because of the difficulties in objectively assessing these parameters, the anastomotic leaks are often diagnosed late. When reoperation is required, a permanent stoma may be made at the level of the sigmoid colon. The CARP system has been developed to achieve a safe anastomosis. The CARP is designed to providing an improved contact surface between the two intestinal ends and the ability to precisely investigate the anastomosis during and after surgery using the catheters of the CARP system. Standardized use of the CARP to anastomose the large intestine may provide significant advantages in the field of colorectal surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 - 90 years (male or female)
  • Planned resection due to benign or malign disease in the left colon
  • Cognitive ability to take part in the study and understand the information he/she receives about participating in the study

排除标准

  • Urgent medical condition requiring immediate care
  • Health condition classified as ASA IV
  • Albumin level less than 25 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 anaesthesia
  • 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

结局指标

主要结局

Complications, including anastomotic leakage, problems with ring evacuation

时间窗: Up to 14 days after operation

次要结局

  • Time to evacuation of the CARP device(1-2 week after operation)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (2)

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