
Now Enrolling! Colovac (SAFE HEAL) Trial for rectal cancer

Low anterior resection surgery
Low anterior resection (LAR) for rectal cancer removes the rectum and lymph nodes. The colon is then connected to the low rectum or anus. This is often coupled with a temporary ileostomy to divert stool and allow the new connection to heal. It is standard practice to create an ileostomy in patients with low tumors and those who have received radiation. While a temporary ileostomy provides an extra safety net and assures that the new connection heals, for many individuals, the ileostomy may be the most difficult part of the cancer journey.
Colovac
A new device may offer a solution, eliminating the need for an ileostomy for many patients with rectal cancer. Colovac, a colorectal anastomosis protection device intended to reduce the contact of fecal content at the anastomotic site following colorectal surgery. The device is placed at the time of the rectal resection surgery and is fully reversible. Colovac is designed to remain in place for 10 days, until the body’s natural healing and tissue repair processes are complete, after which it is removed during an endoscopic procedure similar to a colonoscopy, without the need for a second surgical intervention.
For the majority of patients, Colovac is expected to eliminate the need for an ileostomy and a second surgery. This enables patients to resume normal activity after their cancer resection surgery without the stigma and complications associated with an ostomy procedure. Colovac is an investigational device, not currently available for sale. A multi-center clinical trial is underway to evaluate the safety and effectiveness of Colovac as an alternative to temporary diverting ostomy. Dr Karen Zaghiyan, MD is the principle investigator of the SAFE clinical trials at Cedars Sinai Medical Center in Los Angeles, CA.
Click here to find out more about Colovac and the current and upcoming clinical trials. We are currently enrolling patients in the standard of care arm (participants are patients of our practice who are treated per standard of care and if clinically indicated, will receive an ileostomy ). In the second phase of the trial, patients will be treated with the Colovac device instead of an ileostomy. During this phase of the study, Dr Zaghiyan will place the Colovac device instead of an ileostomy to protect the new connection during your rectal cancer surgery. You can learn more about the current study here. Alternatively, please contact our practice in Los Angeles for more information at 310-289-9224.
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