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

Since the first clinical report in 2009, Transanal Total Mesorectal Excision (taTME), a novel approach in rectal cancer surgery, has been increasingly adopted worldwide. With taTME, the majority of the rectal dissection is performed transanally through specialized endoscopic platforms, rather than transabdominally, which overcomes many challenges related to deep pelvic dissection. While preliminary outcomes are encouraging, they are limited to case series and one international registry.

The US Multicenter Study of taTME for rectal cancer opened for enrollment in May 2017 (clinicaltrials.gov NCT03144765). This is a 5-year Phase II clinical trial investigating taTME with laparoscopic or robotic assistance in patients with resectable rectal cancer who are eligible for sphincter preservation. This trial is led by Patricia Sylla, MD at Mount Sinai Hospital, with a total of 100 patients to be enrolled among 10 US study sites. It is anticipated that this trial will help validate the safety and efficacy of taTME with respect to the quality of the resection achieved, perioperative outcomes, and oncologic and functional outcomes.

The study is funded in part by a generous grant from the American Society of Colon and Rectal Surgeons Research Foundation (ASCRS RF), and sponsored by SAGES through grant support from Medtronic, Karl Storz, Richard Wolf, Intuitive, Applied Medical, Conmed, Olympus, Novadaq, Ethicon, and Stryker.

For more information regarding the trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03144765?term=sylla&rank=1

Click here to view the Summer 2017 SCOPE Newsletter.

Follow the trial on twitter for the most up-to-date information: https://twitter.com/UStaTMEtrial


Participating Sites (*Actively Enrolling)

Mount Sinai Hospital (New York, NY)*
PI: Patricia Sylla, MD
Study Contact: antoinette.bonaccorso@mountsinai.org
Cleveland Clinic Florida (Weston, FL)*
PIs: Dana Sands, MD & Steven Wexner, MD
Study Contact: mejiam@ccf.org
Providence Cancer Center (Portland, OR)*
PI: Mark Whiteford, MD
Study Contact: caitlin.curtis@providence.org
UC Irvine Hospital (Orange County, CA)*
PI: Alessio Pigazzi, MD
Study Contact: chavezc@uci.edu
Lankenau Medical Center (Wynnewood, PA)*
PI: John Marks, MD
Study Contact: cancertrials@mlhs.org
Kaiser Permanente (Los Angeles, CA)*
PI: Elisabeth McLemore, MD
Study Contact: sandra.t.baker@kp.org
Florida Hospital (Orlando, FL)*
PI: Matthew Albert, MD
Study Contact: Sarah.George@flhosp.org
University of Massachusetts (Worchester, MA)*
PIs: Justin Maykel, MD & Karim Alavi, MD
Study Contact: sharon.balcom@umassmed.edu
Cleveland Clinic (Cleveland, OH)
PI: Scott Steele, MD
Lahey Clinic (Burlington, MA)
PI: Peter Marcello, MD
Cedars Sinai Medical Center (Los Angeles, CA)*
PI: Karen Zaghiyan, MD
Study Contact: gayane.ovsepyan@cshs.org

 


Supporters

Applied Medical
Conmed
Ethicon
Intuitive
Karl Storz
Medtronic
Novadaq
Olympus
Richard Wolf
Stryker

If you would like to support this study, please contact Shelley Ginsberg at shelley@sages.org.

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