Under the direction of site Principal Investigator Dr. Jorge Marcet, professor in the Department of Surgery and director of Colon and Rectal Surgery at the USF Health Morsani College of Medicine and colon and rectal surgeon at Tampa General Hospital, the first-ever Colovac™ procedure in the U.S. was successfully performed on the study’s first enrolled patient.
Colovac is intended as an alternative to temporary diverting ostomy for patients undergoing colorectal resection. Up to 20 U.S. and European sites will enroll patients in the study. A groundbreaking endoluminal bypass sheath, Colovac was developed by SafeHeal™, a leading innovator in the field of digestive surgery.
Currently, patients undergoing a colorectal resection receive an ostomy to create an opening from inside the body to the outside, providing a new way for waste to leave the body into a pouch worn by the patient.
“We are excited to be the first investigative site in the U. S. to enroll patients in SafeHeal’s clinical trial of the Colovac device,” Marcet said. “Treatment of rectal cancer most often involves radiation and chemotherapy followed by surgical removal of the rectum. Because the risk of non-healing of the bowel anastomosis is high, and the consequences could be dire, the surgeon temporarily diverts the stool from the anastomosis by creating an ostomy. The patient keeps the ostomy for about 2-6 months, and the eventual reversal of the ostomy requires another operation, hospitalization, and recovery period. The aim of the SafeHeal study is to see if these patients can safely avoid an ostomy and avoid additional operations. Our initial experience with this device is positive and we are excited to be able to offer this cutting-edge technology to our patients as part of the study.”
The highest-ranked hospital in the market in U.S. News & World Report’s 2021-22 Best Hospitals, and one of the top four hospitals in Florida, Tampa General is one of the top-rated hospitals in Florida for gastroenterology and gastrointestinal surgery. The academic medical center is #26 in the country and #1 in Florida. “We are intently focused on providing the safest and most innovative care for patients with colorectal cancer, which is why we are always eager to participate in clinical trials,” Marcet noted.
An anastomosis is a surgical connection between two structures. When part of an intestine is surgically removed, the two remaining ends are sewn or stapled together (anastomosed). The procedure is known as an intestinal anastomosis.
The SAFE-2 randomized controlled IDE study will assess the safety and efficacy of the Colovac endoluminal (within the intestine) bypass sheath in adult patients who were initially scheduled to receive a diverting ostomy following colorectal surgery. Diverting ostomy, the current standard of care, is applied prophylactically to most patients today undergoing a low anterior resection (LAR) and anastomosis, due to the high risk of anastomotic leak in this patient cohort. Anastomotic leakage, or an incomplete healing of the anastomosis, occurs in up to 20 percent of patients undergoing LAR. It is considered to be one of the most serious complications of colorectal surgery, frequently resulting in the rapid development of severe peritonitis, septic shock, multiple organ dysfunction, and potential mortality.