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Electric Tubular Anastomosis in Rectal Cancer

ABSTRACT: Compared with traditional manual suturing, mechanical anastomosis can reduce the error caused by human factors. The electric anastomotic device can improve the automation and accuracy of anastomosis, reduce the requirements for doctors’ operation, and establish a more standardized usage specification, thereby reducing the surgical complication rate and improving the quality of anastomosis. The clinical study of electric tubular anastomotic device adopts a multicenter, randomized, parallel controlled non-inferior study design, and randomly groups according to the 1:1 ratio to evaluate the clinical effectiveness and safety of electric tubular anastomotic device compared with conventional manual device.

DISEASE(S): Rectal Neoplasms,Anastomosis,Rectal Cancer

PROVIDER: 61578 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description: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 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.

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Electric Tubular Anastomosis in Rectal Cancer

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