Lankenau Medical Center, part of Main Line Health, was certified as the first external site in the United States to initiate a new clinical trial to test a novel approach to rectal cancer surgery. Transanal Total Mesorectal Excision (taTME) uses a so-called “bottom-up approach” in which dissection of the affected tissues is done transanally rather than through the abdomen.
Each year, 40,000 people are diagnosed with rectal cancer in the U.S. Although chemotherapy and radiation play an important role in the treatment of advanced rectal cancer, surgery remains essential to disease management. While taTME has been performed by surgeons since 2009, results have been limited to case studies and one international registry. The purpose of this clinical trial is to discover whether taTME is effective compared to the standard laparoscopic robotic technique.
The study is based on the TATA procedure that was developed and first performed by the team of John H Marks, MD, chief of colorectal surgery and director of minimally invasive colorectal surgery and rectal cancer management fellowship program at Main Line Health. Dr. Marks will serve as Main Line Health’s principal investigator for the study.
“We are honored to be named the first external site for this important multi-center treatment study for patients battling rectal cancer,” said Dr. Marks, who also serves as a clinical professor at the Lankenau Institute of Medical Research (LIMR), part of Main Line Health. “It is gratifying to be involved in this study that aims to validate across the country many of our groundbreaking contributions to rectal cancer management. These types of endeavors help solidify Lankenau’s position as a leader in the country in the care of patients with rectal cancer, as well as a world leader in minimally invasive surgery.”
The taTME procedure combines standard laparoscopy, or multiple small abdominal incisions, with surgery through the anus to remove cancerous tissue of the rectum. An alternative to standard abdominal surgery, taTME overcomes many challenges related to deep pelvic surgeries. The clinical trial seeks to validate the safety and efficacy of taTME with respect to the quality of the resection achieved, as well as perioperative, oncologic and functional outcomes.
This national study (clinicaltrials.gov #NCT03144765) is being led by a physician at Mount Sinai Hospital, New York City, and is being funded in part by a grant from the American Society of Colon and Rectal Surgeons Research Foundation. The sponsor is the Society of American Gastrointestinal and Endoscopic Surgeons through grant support from Medtronic, Karl Storz, Richard Wolf, Intuitive, Applied Medical, Conmed, Olympus, Novadaq, Ethicon, and Stryker.
Patients with resectable rectal cancer who are eligible for sphincter preservation and who are interested in participating in this five-year, phase II clinical trial should contact their physician to learn more. They can also visit the National Institutes of Health taTME trial page, or call Elene Turzo, manager of clinical cancer research at LIMR, 484.476.2649, or firstname.lastname@example.org.