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Transanal Total Mesorectal Excision with Laparoscopic Assistance in Treating Patients with Rectal Cancer

Trial Status: Active

This phase II trial studies how well transanal mesorectal excision with laparoscopic assistance works in treating patients with rectal cancer. Transanal mesorectal excision with laparoscopic assistance is a procedure that combines standard laparoscopy, or multiple small abdominal incisions, with surgery through the anus in order to remove rectal cancer, and it may work better in treating patients with rectal cancer.

Inclusion Criteria

  • New diagnosis of histologically confirmed adenocarcinoma of the rectum
  • Rectal cancer originally staged as T1, T2, or T3, node negative (N0) or node positive (N1, N2) by pelvic magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Circumferential radial margin not involved with tumor on pelvic MRI
  • No evidence of metastasis on staging computed tomography (CT) or positron emission tomography (PET) CT scans of the chest, abdomen and pelvis
  • Rectal cancer located within 10 cm from the anal verge based on proctoscopy and digital rectal examination (DRE)
  • Complete preoperative colonoscopy demonstrating no synchronous colon cancer
  • Participants must be eligible to undergo laparoscopic or robotic low anterior resection with or without a temporary diverting stoma, based on multidisciplinary tumor board consensus
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Rectal cancer staged as T4 by pelvic MRI
  • Participants with preoperatively staged T3, N1, or N2 tumors who return > 12 weeks following completion of neoadjuvant chemoradiation therapy (CRT)
  • Severely symptomatic rectal tumors (near-completely obstructing, symptomatic bleeding)
  • Tumors invading into the internal anal sphincter muscle based on DRE and pelvic MRI
  • Fecal incontinence at baseline
  • Prior history of rectal resection
  • Prior history of colorectal cancer
  • History of inflammatory bowel disease
  • Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with chemotherapy and/or radiation
  • Subjects who cannot read or understand English


Los Angeles
Cedars Sinai Medical Center
Status: ACTIVE
Contact: Karen N. Zaghiyan
Phone: 310-289-9224
Kaiser Permanente Los Angeles Medical Center
Status: ACTIVE
Contact: Elisabeth Christine McLemore
Phone: 323-783-6848
UC Irvine Health / Chao Family Comprehensive Cancer Center
Contact: Alessio Pigazzi
Phone: 714-456-6924


AdventHealth Orlando
Status: ACTIVE
Contact: Matthew Albert
Phone: 407-303-2615
Cleveland Clinic-Weston
Status: ACTIVE
Contact: Dana Sands
Phone: 954-659-5251


Lahey Hospital and Medical Center
Status: ACTIVE
Contact: Peter W Marcello
Phone: 781-744-3706
UMass Memorial Medical Center - University Campus
Status: ACTIVE
Contact: Justin A. Maykel
Phone: 508-334-8195

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Contact: Antoinette M Bonaccorso
Phone: 212-241-2065
Mount Sinai Union Square
Status: ACTIVE
Contact: Patricia Sylla
Phone: 212-241-2895
Mount Sinai West
Status: ACTIVE
Contact: Patricia Sylla


Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Status: ACTIVE
Contact: Scott Russell Steele
Phone: 216-444-4715


Providence Cancer Center
Status: ACTIVE
Contact: Mark H. Whiteford
Phone: 503-963-2866


Lankenau Medical Center
Status: ACTIVE
Contact: John H. Marks
Phone: 610-645-9093


Toronto Western Hospital
Status: ACTIVE
Contact: Sami A Chadi


I. To determine the efficacy of transanal (ta) total mesorectal excision (TME) as defined by pathological assessment of complete and near-complete mesorectal excision based on standard guidelines on pathologic evaluation of TME specimens.


I. To perform complete pathologic assessment of the surgical specimen.

II. To determine the incidence of 30-day perioperative complications including intraoperative and postoperative complications.

III. Long-term (> 30 days) complications.

IV. Changes in functional results (bowel function, urinary function, and sexual function).

V. Assess 3-year oncologic outcomes (recurrence and survival).


Patients undergo taTME with laparoscopic assistance.

After completion of study treatment, patients are followed up for up to 5 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Icahn School of Medicine at Mount Sinai

Principal Investigator
Patricia Sylla

  • Primary ID 16-2009
  • Secondary IDs NCI-2017-01497
  • ID NCT03144765