taTME Surgery for Rectal Cancer

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen byPatricia Sylla, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Icahn School of Medicine at Mount Sinai

No Placebo Group

Trial Summary

What is the purpose of this trial?

Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation treatment (CRT), complete TME with negative resection margins is associated with sustained local and systemic control even in locally advanced disease. Over the last 2 decades, laparoscopic and robotic techniques have been increasingly adopted due to reduced surgical trauma and faster patient recovery. Yet, both approaches are associated with equivalent postoperative morbidity and disturbances in sexual, urinary and defecatory function relative to open TME. Furthermore, laparoscopic and robotic TME remain associated with substantial conversion rates and variable rates of TME completeness as a result of the procedural difficulties reaching the low rectum from the abdominal approach. Transanal TME (taTME) with laparoscopic assistance was developed to facilitate completion of TME using a primary transanal endoscopic approach. Transanal TME uses a "bottom-up approach" to overcome the technical difficulties of low pelvic dissection using an abdominal approach. Published results from single-center taTME series and an international registry suggest the short-term procedural and oncologic safety of this approach in resectable rectal cancer. No multicenter phase II study has yet been conducted to validate the procedural safety, functional outcomes or long-term oncologic outcomes of this approach. Study Design: This is a 5-year phase II multicenter single-arm study to evaluate the safety and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic assistance in 100 eligible subjects with resectable rectal cancer. Hypothesis: taTME is non-inferior to standard LAR with respect to the quality of the TME achieved.

Eligibility Criteria

This trial is for adults over 18 with a new diagnosis of rectal cancer, within 10 cm from the anal verge and no evidence of metastasis. They should have an ECOG performance status ≤2, be able to undergo laparoscopic or robotic surgery, and must understand English to give informed consent. Excluded are those with advanced tumor stage cT4, severe symptoms, fecal incontinence, prior colorectal cancer or surgeries, inflammatory bowel disease, uncontrolled illnesses or pregnancy.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My medical team agrees I can have minimally invasive rectal surgery.

My cancer is at an early but high-risk or moderate stage without significant spread to nearby lymph nodes.

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Exclusion Criteria

I have a history of inflammatory bowel disease.

It has been over 12 weeks since I finished my pre-surgery treatment.

My tumor has spread into the internal anal muscle, confirmed by MRI.

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Treatment Details

Interventions

Transanal Total Mesorectal Excision (taTME) (Procedure)

Trial OverviewThe study tests Transanal Total Mesorectal Excision (taTME) combined with laparoscopic or robotic assistance in patients with resectable rectal cancer. It aims to evaluate if taTME is as good as standard low anterior resection surgery regarding safety and long-term outcomes over a period of five years involving 100 subjects.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: taTMEExperimental Treatment1 Intervention

Enrolled subjects will undergo the study procedure, laparoscopically-assisted Transanal Total Mesorectal Excision (taTME).