Project Grant R43CA246987

A NOVEL DEVICE ALTERNATIVE TO TEMPORARY DIVERTING OSTOMIES AFTER RECTAL CANCER SURGERY - PROJECT SUMMARY/ABSTRACT COLORECTAL CANCER IS THE THIRD MOST COMMON CANCER WITH ABOUT 30-40% OF CASES INVOLVING THE RECTUM. RECTAL CANCER IS TYPICALLY TREATED WITH NEOADJUVANT THERAPY AND SURGICAL RESECTION. HOWEVER, ANASTOMOTIC LEAKS CAN OCCUR IN UP 10-18% OF PATIENTS AFTER RESECTION WITH AN ASSOCIATED HIGH MORTALITY DUE TO SEVERE ABDOMINAL SEPSIS. CURRENTLY, DIVERTING OSTOMIES ARE TYPICALLY PLACED ABOVE THE ANASTOMOSIS TO MITIGATE THE SEVERE CONSEQUENCES OF AN ANASTOMOTIC LEAK, BUT TEMPORARY OSTOMIES THEMSELVES ARE HIGHLY MORBID, HAVE SIGNIFICANT RISK OF MORTALITY, ARE EXPENSIVE TO THE HEALTHCARE SYSTEM, AND DRASTICALLY IMPACT PATIENT'S QUALITY OF LIFE. BECAUSE THE MAJORITY OF PATIENTS DO NOT DEVELOP SEVERE ANASTOMOTIC LEAKS, MOST PATIENTS WHO RECEIVE TEMPORARY OSTOMIES END UP NOT ACTUALLY REQUIRING THEM. THERE EXISTS A MEDICAL NEED TO PROVIDE PROTECTION TO AN ANASTOMOSIS TO PREVENT THE SEVERE CONSEQUENCES OF LEAKS WITHOUT THE MORBIDITY OF A TEMPORARY OSTOMY. SAVAGE MEDICAL HAS DEVELOPED AN INTRALUMINAL FECAL DIVERSION DEVICE THAT UTILIZES A NOVEL ANCHORING MECHANISM THAT IS SAFE, RELIABLE, EASILY REVERSIBLE, AND ELIMINATES THE NEED FOR TEMPORARY OSTOMY SURGERY FOR MOST RECTAL CANCER PATIENTS. THIS TECHNOLOGY ALLOWS FOR ONLY THOSE SMALL PERCENT OF PATIENTS WHO DEVELOP SEVERE LEAKS TO UNDERGO OSTOMY SURGERY WHILE SPARING THE VAST MAJORITY OF RECTAL CANCER PATIENTS FROM REQUIRING AN OSTOMY. ELIMINATING THE NEED FOR A TEMPORARY OSTOMIES WOULD ON AVERAGE SAVE OVER $25K PER PATIENT IN DIRECT SURGICAL COSTS (OSTOMY SURGERY AND REVERSAL SURGERY) AND ELIMINATE $8.5K PER PATIENT IN ANNUAL OSTOMY MAINTENANCE COSTS. THE QUALITY OF LIFE FOR PATIENTS WHO WOULD AVOID OSTOMIES DUE TO THIS TECHNOLOGY WOULD ALSO BE PROFOUNDLY IMPROVED DURING THEIR CANCER TREATMENT. THIS PROPOSED PROJECT IS TO PERFORM DESIGN VERIFICATION TESTING AND LARGE ANIMAL VALIDATION TESTING IN AN ANASTOMOTIC LEAK MODEL FOR THIS NOVEL MEDICAL DEVICE.