MedTrace Logo

Multicenter Phase II Study of Transanal TME (taTME)

NCT03144765 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Transanal Total Mesorectal Excision (taTME)

Study procedures consist in 1-team (sequential) or 2-team (combined) low anterior resection with transanal TME using laparoscopic or robotic abdominal assistance.

Sponsors & Collaborators

  • Society of American Gastrointestinal and Endoscopic Surgeons

    collaborator OTHER

  • Research Foundation of the American Society of Colon and Rectal Surgeons

    collaborator OTHER

  • Icahn School of Medicine at Mount Sinai

    lead OTHER

Principal Investigators

  • Patricia Sylla, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2022-05-02
Completion
2027-04-12

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03144765 on ClinicalTrials.gov