Anastomotic leakage (AL) is a dreaded complication that occurs following colon resection (in up to 26% of patients) and involves a leak of faecal contents into the abdominal cavity. This results in increased morbidity, mortality and increased length of hospital stay and cost. AL has been associated with a 6-39% mortality rate and a 10-100% risk of permanent stoma. The development of a leak correlates with worse prognosis after a curative resection for colorectal cancer. Because surgeons are unable to reliably predict which anastomosis would fail, most will construct a diverting ileostomy for low colorectal anastomosis to circumvent the devastating complications of anastomotic failure.
Despite extensive investigations on technical considerations of anastomosis construction, anastomotic leaks continue to occur at an unacceptably high rate. Typically to prevent the leak, cancer sufferers will undergo a stoma (also called ostomosis) surgical procedure that usually diverts the small bowel toward the abdominal wall in order to prevent faecal content reaching the ansatamosis area, prevent the clinical outcome of anastomic leakage and allowing healing of the anasatamosis area in the meantime. An ostomy bag is connected to the stoma to collect waste. This procudure is carried out in 70 % of patients following colorectal surgery, neverthless, leakage may still occur in up to 3 % of these patients . The diverting stoma leads to a low quality of life for patients, 17 % of patients have complications and 3 % of patients require reoperation. Approximately 700,000 people in the European Union, from young children to senior citizens, have an ostomy, a surgical procedure that creates an artificial opening in the abdomen to the intestines or urinary system to allow for the elimination of bodily wastes. The use of diverting stoma to prevent AL, results in staggering costs for the patient and healthcare system (51,422 EUR total cost per patient).
We have developed a novel device, termed the CG-100, which acts as an internal bypass for waste, removing the need for an external stoma and the resulting ostomy bag. The CG-100 reduces contact between faecal content and the anastomosis site and prevents these complications. The CG-100 also provides the ability to easily perform leak detection during the post-operative period. Overall the CG-100 device will greatly contribute to the sustainability of the health care system by reducing the need for hospital interventions, greatly lowering the cost sustained by healthcare centres and the time spent on doctor-patient interactions and hospitalisation. Although the purpose of ostomy is to treat and reduce patients’ pain and discomfort, but in many cases ostomy leads to intensified distress and suffering for patients, and causes severe stress as a result of skin irritation (76%), pouch leakage (62%), offensive odour (59%), reduction in pleasurable activities (54%), and depression/anxiety (53%). CG-100 removes these effects by eliminating the need for an ostomy bag altogether and hence increases the quality of life of patients undergoing colon resection procedure.
