Colorectal cancer is the third most commonly occurring cancer in men and the second most commonly occurring cancer in women. There were over 1.8 million new cases worldwide in 2018.
Generally colorectal cancer is being treated with surgery by cutting away the diseased part in the rectum and joining the two new ends together resulting in an anastomosis (which is the resultant scar).
This anastomosis can be susceptible to infection and thus must be protected immediately after surgery for this reason. The most serious complication encountered with colorectal surgery is anastomotic leakage, it can occur when the healing process is delayed or incomplete, allowing feces to leak into the abdominal cavity.
This can in itself lead to extended hospitalisation and possible associated infections which need to be treated resulting in additional cost and even further re-operations.
Traditionally to prevent potential leakage, surgeons create an external bypass, called diverting ostomy: the surgeon creates a temporary artificial anus and affixes a bag to the abdomen skin to collect the patient’s feces.
This method can be both distressing and inconvenient for many patients as:
– the stoma is a burden for patient social life
– the stoma has complications or infection that can arise
– and in addition, the closing of the stoma requires additional surgery.
SafeHeal introduces Colovac, an improved alternative to traditional care
Colovac is an internal flexible bypass sheath designed to protect the anastomosis, by eliminating the contact with feces and to avoid diverting ostomy in most of eligible patients undergoing the colectomy.
The cancer surgery is performed following standard procedures. Once the surgery is finished, instead of creating a diverting ostomy, the Colovac is introduced in the colon and placed against the internal walls of the patient’s colon. This ensures the cleanliness of the anastomosis minimising any leak of the anastomosis as all colon content passes through the sheath without contact with the newly joined wall. The Colovac remains in place for 10 days, compared to several months for traditional ostomy duration.
After 10 days, when healing is complete and the risk of leakage is greatly reduced, the Colovac can be removed through a routine endoscopic procedure without a second surgery.
In case of leakage the patient can return to standard of care, which means diverting ostomy.
The Colovac device is an investigational device, not currently available for sale.
In most cases, using Colovac means no need for a temporary ostomy (artificial anus), no need to live with an ostomy bag, and does not require a second surgery to reverse the ostomy. Based on these benefits, Colovac can potentially allow patients to return more quickly to their normal routine and active life.
Colovac is designed to provide noninvasive protection of the anastomosis during colorectal patients’ 10-day postoperative healing stage, giving the majority of patients the choice of avoiding a diverting ostomy.
Colovac is comprised of a flexible bypass sheath that is anchored to the colon using a vacuum stent placed proximal to the anastomosis. The device is a minimally invasive, fully reversible internal bypass that isolates the anastomosis line from any contact with the fecal content during patients’ recovery, minimizing the sequelae of an anastomotic leakage (i.e. peritonitis).