You are here

Multicenter Phase II Study of Transanal Total Mesorectal Excision (taTME) with Laparoscopic Assistance for Rectal Cancer

Multicenter Phase II Study of Transanal Total Mesorectal Excision (taTME) with Laparoscopic Assistance for Rectal Cancer | ASCRS

Transanal Total Mesorectal Excision (taTME) is a novel minimally invasive surgical approach for the treatment of rectal cancer. With the taTME approach, much of the rectal dissection is completed transanally through specialized endoscopic platforms, which overcomes many of the challenges related to deep pelvic dissection.

Since the first taTME clinical report in 2009, the approach has been increasingly adopted worldwide. While preliminary outcomes of taTME are encouraging, they are limited to case series and one international registry.

The U.S. Multicenter Study of taTME for rectal cancer opened for enrollment in May 2017. This is a five-year Phase II clinical trial investigating taTME with laparoscopic or robotic assistance in patients with resectable rectal cancer and who are eligible for sphincter preservation. The trial will enroll a total of 100 patients over 11 U.S. study sites. It is anticipated that this trial will help validate the safety and efficacy of taTME with regards to three outcomes: quality of the resection achieved, perioperative outcomes, and oncologic and functional outcomes.

The trial is led by Patricia Sylla, MD, at Mount Sinai Hospital and is funded in part by a generous grant from the Research Foundation of the American Society of Colon and Rectal Surgeons. The trial is also sponsored by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) through grant support from Applied Medical, Conmed, Ethicon, Intuitive, Karl Storz, Medtronic, Novadaq, Olympus, Richard Wolf, and Stryker.

For more information regarding the trial, please visit clinicaltrials.gov.

To register for the taTME course at the ASCRS Annual Scientific Meeting visit the course registration page.

Participating Sites

Mount Sinai Hospital
(New York, NY)*

PI: Patricia Sylla, MD
Email Study Contact

Cleveland Clinic Florida
(Weston, FL)*

PIs: Dana Sands, MD & Steven Wexner, MD
Email Study Contact

Providence Cancer Center
(Portland, OR)*

PI: Mark Whiteford, MD
Email Study Contact 

UC Irvine Hospital
(Orange County, CA)*

PI: Alessio Pigazzi, MD
Email Study Contact

Lankenau Medical Center
(Wynnewood, PA)*

PI: John Marks, MD
Email Study Contact

Kaiser Permanente
(Los Angeles, CA)*

PI: Elisabeth McLemore, MD
Email Study Contact

Florida Hospital
(Orlando, FL)*

PI: Matthew Albert, MD
Email Study Contact

University of Massachusetts
(Worchester, MA)*

PI: Justin Maykel, MD & Karim Alavi, MD
Email Study Contact

Cleveland Clinic
(Cleveland, Ohio)*

PI: Scott Steele, MD
Email Study Contact

Lahey Hospital
(Burlington, MA)*

PI: Peter Marcello, MD
Email Study Contact

Cedars Sinai Medical Center
(Los Angeles, CA)*

PI: Karen Zaghiyan, MD
Study Contact

*Actively Enrolling
Version 2/19/19