How SafeHeal Improves Patient Recovery After Colorectal Surgery

Treatment of Colorectal Cancer

Colon cancer is the second most commonly occurring cancer in women, and the third most commonly occurring cancer in men. There were over 1.9 million new cases worldwide in 2020. Of these 1.9 million cases of cancer in the colon, approximately 500,000 are located in the rectum, the lowest segment of the colon. The following information is specific to the treatment of rectal cancer.

Treatment of rectal cancer most often involves radiation and chemotherapy followed by surgical removal of some or all of the rectum. The colon is then reconnected to the remaining rectum or anus with surgical staples or sutures; this connection is called an anastomosis.

Because the risk of incomplete healing of the colon anastomosis is high, and the consequences could be dire, the surgeon may also create an ostomy (also called a stoma), which temporarily diverts the stool away from the healing anastomosis to the outside of the body and into an ostomy bag. Usually the ostomy is needed only until the rectum has healed, and then it can be reversed. If the entire rectum is removed, however, the ostomy may be permanent.

If the ostomy is intended to be temporary, the patient typically keeps the ostomy for approximately 2-9 months. The eventual reversal of the ostomy requires another operation, with a second hospital stay and recovery period.

An illustration of the colon within the human body and identifying where the cancer may be located and then removed.

Resection of the Rectum with Anastomosis

As with any surgery, complications can develop. While an ostomy procedure after rectal resection surgery is the current standard of care to provide protection to the healing anastomosis, specific risks are associated with the ostomy operation. The most common of these complications may include:

Dehydration
Irritation and inflammation of the skin around the ostomy
A hernia at the site of the ostomy

Additionally, complications may develop from the secondary surgery 2-9 months later to reverse the ostomy.

In addition to physical complications, ostomy patients may experience an impact to their quality of life, due to:

Social isolation
Reduced physical activity and/or intimacy
Extended recovery after cancer surgery
Added expense of ostomy supplies

About Colovac¹

Colovac is 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 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.

A timeline graphic showing possible 6 steps for treatment if you don't use the Colovac method.

Rectal Cancer Treatment without Colovac

Time to Full Recovery: 2-9 months
2 Surgeries, 2 Hospital Stays
Risk of Complications
- 2 Surgeries Under Anesthesia
- Additional Incisions
- Ostomy Complications
- Risk of Permanent Ostomy

Quality of Life Due to Ostomy Bag
- Social Isolation
- Impact to Physical Activity and Intimacy
- Added Expense of Ostomy Supplies
Cost to Patient and Health Care System
- Multiple Surgeries and Hospital Stays
- Time to Full Recovery

A timeline graphic showing 3 stages of recovery when using the Colovac method.

Rectal Cancer Treatment with Colovac

Time to Full Recovery: as little as 2 weeks
Only 1 Surgery and Hospital Stay
Risk of Complications
- Single Surgery under Anesthesia
- No Ostomy Complications

Patient Satisfaction
- No Ostomy Bag, No Lifestyle Changes
- Faster Return to Normal Life
Decreased Cost to Patient and Health Care System
- Single Surgery and Hospital Stay
- Reduced Time to Full Recovery

About the Colovac Clinical Study

Following pilot studies in Europe in which 70% of patients avoided an ostomy, SafeHeal is currently enrolling patients in a larger clinical study at up to 25 leading academic medical centers in the United States and Europe. The aim of the SafeHeal study is to assess the potential for patients with rectal cancer to safely avoid an ostomy with the use of a novel device, the Colovac colorectal anastomotic protection device.

Colovac Potential Benefits
Patients may avoid an ostomy
No second surgery and hospital stay
Faster return to normal life

Karen Zaghiyan, MD
Cedars-Sinai Medical Center

Justin Maykel, MD
UMASS Memorial Medical Center

The study consists of two phases; the first phase of the overall study is called SH-SOC23.

What is the SH-SOC23 clinical study?

SH-SOC23 is a single arm, prospective, non-randomized, clinical study that will provide additional monitoring of anastomotic healing to otherwise Standard-of-Care treatment for rectal cancer. This study is currently enrolling patients in the U.S. and Europe.

What is the goal of SH-SOC23?

This first phase of the two-part study will assess the rate of complications associated with the current standard-of-care surgery for rectal cancer. The information collected will be compared to the second phase of the study to be conducted later, which will involve the use of the Colovac device. The overall goal of the two-phase study is to validate the Colovac device as a safe and effective alternative to diverting ileostomy.

Why should a patient consider participating in SH-SOC23?

Participation will provide patients with a more rigorous monitoring and follow-up of their post-surgical healing status, as compared to the current standard-of-care. Patients may experience a faster recovery with fewer complications due to:
- Early examination of the healing status of the anastomosis, which may minimize risks associated with leak
- Identification of other anastomotic complications which may be treated earlier, even before symptoms arise
- Early confirmation of a healed anastomosis may lead to an earlier stoma reversal (at surgeon discretion)
The schedule of follow-up visits is consistent with the normal follow-up associated with cancer care
There is no additional cost to the patient to participate in the SH-SOC23 study. Additionally, patients are compensated up to $1200 for completion of the required follow-up steps.
Patients who participate are contributing to the body of evidence that may allow future patients to avoid an ostomy

The Institutional Review Board of each participating Clinical Study Site has assessed the risks associated with the SH-SOC23 protocol, and that appropriate steps have been taken to protect the rights and welfare of humans participating in the study.

You may be eligible to participate in the SH-SOC23 study if you;

Are 18 years old or older
Are undergoing a rectal cancer resection with a planned diverting ostomy

The following clinical partners are currently enrolling patients.
Please contact the surgeon investigator nearest you to discuss your eligibility for the SH-SOC23 study.