Transanal Total Mesorectal Excision with Laparoscopic Assistance in Treating Patients with Rectal Cancer
- 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
- 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
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
Icahn School of Medicine at Mount Sinai
- Primary ID 16-2009
- Secondary IDs NCI-2017-01497
- Clinicaltrials.gov ID NCT03144765