ECO-LEAK Technique: Early Detection of Colorectal Anastomotic Leakage by Transvaginal Ultrasound
Ontology highlight
ABSTRACT:
DISEASE(S): Gynecologic Cancer,Anastomotic Leak,Cytoreductive Surgery
PROVIDER: 66261 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:The study is based on the hypothesis that patients with postoperative anastomotic leakage have a different bacterial profile contributing to poor tissue healing, and that patients operated for colon cancer presumably have a different preoperative microbiota than healthy patients. This different composition is probably induced by the high heme level in the light intestinal tract that tumor spoliation generates.
The objective of the study is to evaluate the feasibility of a larger study to evaluate the difference between microbiota composition of patients with and without colorectal cancer, with inflammatory bowel disease and those with and without anastomotic leakage postoperatively of a colonic resection.
Stool samples will be taken from 20 patients, including 5 without intestinal pathology, 5 with colorectal cancer undergoing colorectal surgery, 5 with inflammatory bowel disease and 5 with anastomotic leakage after colectomy for colorectal cancer or inflammatory bowel disease.
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Project description:Anastomotic leakage is serious morbidity that can develop in patients operated on for colorectal cancer and can reach potentially life-threatening dimensions. Many international studies have been conducted to reduce and eliminate this postoperative complication that may have a mortal course. In these studies, preoperative, perioperative and postoperative factors of the patient, operation techniques, structure of the material used in the operation and multiple factors belonging to the surgeon were held responsible. Intraabdominal sepsis secondary to late anastomotic leakage and subsequent multiorgan failure can cost the patient’s life. Anastomotic leaks that develop in patients who have been operated for colorectal cancer; In order to detect patients’ postoperative clinical findings, laboratory examinations, imaging tests, and to eliminate them before intraabdominal sepsis develops, studies including many different laboratory and imaging methods have been carried out. Although previous studies have shown that there are many laboratory examinations and imaging methods that can predict anastomotic leaks early, they have many advantages over each other in terms of efficiency, sensitivity, specificity, and cost.
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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.
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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. 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.
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