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.
Additional locations may be listed on ClinicalTrials.gov for NCT03144765.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVES:
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).
OUTLINE:
Patients undergo taTME with laparoscopic assistance.
After completion of study treatment, patients are followed up for up to 5 years.
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorPatricia Sylla