Have you been diagnosed with Rectal Cancer?

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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 successful pilot studies in Europe in which the majority of patients avoided an ostomy, SafeHeal is preparing to enroll 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 will be to assess the potential for patients with rectal cancer to safely avoid an ostomy in favor 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

You may be eligible to participate in the Colovac study if you:

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

Watch this space for updates on the Colovac clinical study.

An illustrated map of America with dots marking locations in California, Illinois, Florida, New York, Connecticut, and Pennsylvania.
An illustrated map of Europe with highlighted states and cities

Clinical Partners:

United States

California

Cedars-Sinai Medical Center
Los Angeles, CA
Karen Zaghiyan, MDCONTACT: Gayane Ovsepyan
Research & Education Program Coordinator
Gayane.Ovsepyan@cshs.org
(310) 289-9224
Kaiser Permanente Los Angeles
Medical Center

Los Angeles, CA
Elisabeth McLemore, MDCONTACT: Andrew Oh
Research Associate III
Andrew.Oh@kp.org
(323) 783-5475
Keck Medicine of USC
Los Angeles, CA
Sang Lee, MDCONTACT: Valentina Rodina
Clinical Research Coordinator Supervisor
Valentina.Rodina@med.usc.edu
(323) 394-0756

Florida

Tampa General Hospital
Tampa, FL
Jorge Marcet, MDCONTACT: Avennette Pinto
Clinical Research Associate
apinto@usf.edu
(813) 844-7948
University of Miami Medical Center
Miami, FL
A man with a purple tie and light beard in front of a gray background.Nivedh Paluvoi, MDCONTACT: Erick Ponce
Clinical Research Coordinator
exp554@miami.edu
(305) 243-7298

Illinois

Northwestern University
Chicago, IL
A man smiles in front of a white back drop.Scott Strong, MDCONTACT: Sharnia Lashley
Clinical Operations Manager
sharnia.lashley@northwestern.edu
(312) 926-0159

More


Massachusetts

Boston Medical Center
Boston, MA
A woman with curly dark hair smiles and wears a white lab coat.Jennifer Davids, MDCONTACT: Kate Cilley
Research Coordinator
Katherine.Cilley@bmc.org
(617) 414-8092
UMASS Memorial Medical Center
Worcester, MA
Justin Maykel, MDCONTACT: Samuel Feinberg
Clinical Research Coordinator II
Samuel.Feinberg1@umassmed.edu
(508) 334-4918

New York

Lenox Hill Hospital
New York, NY
Joseph Martz, MDCONTACT: Sasha Suarez, MD
Clinical Research Coordinator
SSuarez3@northwell.edu
(212) 434-4350
Maimonides Medical Center
New York, NY
Rebecca Rhee, MDCONTACT: Gene Sobol
Director, Performance Improvement
GSobol@maimonidesmed.org
(718) 283-7926
Mount Sinai Hospital
New York, NY
Patricia Sylla, MDCONTACT: Roxanne Mistry
Clinical Research Coordinator I
Roxanne.Mistry@mountsinai.org
(212) 241-0492
New York Presbyterian-Weill Cornell Medical Center
New York, NY
A woman with dark, long hair looks intently at the camera.Dorna Jafari, MDCONTACT: Rohit Rasane
Clinical Research Specialist
rkr4004@med.cornell.edu
(646) 962-2789

Pennsylvania

Main Line Health System
Philadelphia, PA
John Marks, MDCONTACT: Desirae Chandran
Oncology Clinical Research Coordinator I
ChandranD@mlhs.org
(484) 476-2395

Europe

Belgium

Antwerp University Hospital
Edegem, Belgium

France

Bordeaux Colorectal Institute Clinique Tivoli-Ducos
Bordeaux, France
CHU de Rouen
Rouen, France
Hôpital Saint-Antoine AP-HP
Paris, France
Hôpital Saint-Louis AP-HP
Paris, France
IHU Institut Hospitalo-Universitaire de Strasbourg
Strasbourg, France

Italy

Istituto Clinico Humanitas
Milan, Italy
A man in a white doctor's coat stands against a hospital wall.Prof. Antonino Spinelli
antonino.spinelli@hunimed.eu

1 Colovac is an Investigational Device, Limited by Federal (or United States) Law to Investigational Use.

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