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Multicenter Phase II Study of Transanal TME (taTME)
NCT03144765 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- PROCEDURE Transanal Total Mesorectal Excision (taTME)
Study Locations (12)
California
- Kaiser Permanente — Los Angeles
- Cedars Sinai Medical Center — Los Angeles
- UC Irvine Hospital — Orange
Florida
- Florida Hospital — Orlando
- Cleveland Clinic Florida — Weston
New York
- Mount Sinai Beth Israel — New York
- Icahn School of Medicine at Mount Sinai — New York
Massachusetts
- University of Massachusetts — Worcester
Ohio
- Cleveland Clinic — Cleveland
Oregon
- Providence Portland Medical Center — Portland
Pennsylvania
- Lankenau Institute — Wynnewood
Other
- Toronto Western Hospital — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-09-25 |
| Est. Completion | 2027-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03144765
The ClinicalTrials.gov registry entry for NCT03144765 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 946 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Surgery appearing as the primary indexed condition, and to 1 intervention — of which Transanal Total Mesorectal Excision (taTME) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03144765 reports 12 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03144765 about?
NCT03144765 is a clinical study titled "Multicenter Phase II Study of Transanal TME (taTME)". 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 contr...
What is the current status of trial NCT03144765?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2017-09-25. Estimated completion is 2027-04.
What conditions does trial NCT03144765 study?
This clinical trial studies the following conditions: Surgery, Rectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03144765?
The interventions under investigation include: Transanal Total Mesorectal Excision (taTME) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03144765?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 946 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03144765 being conducted?
This trial has 12 study locations across California, Florida, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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