NCT03144765Active, not recruiting
Multicenter Phase II Study of Transanal TME (taTME)
Multicenter Phase II Study of Transanal Total Mesorectal Excision (taTME) With Laparoscopic Assistance for Rectal Cancer
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 5 May 2017
- Start date
- 25 Sept 2017
- Primary completion date
- 2 May 2022
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Colorectal cancer
- NCT number
- NCT03144765
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 25 Sept 2017 to the primary completion date, 2 May 2022
- 12 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of rectal resection
- Prior history of colorectal cancer
- Uncontrolled concurrent illness
Other illness
- History of inflammatory bowel disease
Other
- cT4 on staging pelvic MRI
- \>12 weeks delay between completion of neoadjuvant CRT and planned study procedure
- Severely symptomatic rectal tumors
- Tumors invading into the internal anal sphincter muscle based on DRE and pelvic MRI
- Fecal incontinence at baseline
- Pregnancy
- Subjects who cannot read or understand English
Who the study is looking for
- New diagnosis of histologically confirmed adenocarcinoma of the rectum
- Age ≥18
- Clinical stage cT1 (high-risk), T2, or T3, cN0, N1, N2 on staging pelvic MRI
- Negative predicted CRM on staging pelvic MRI
- No evidence of metastasis on 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
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
- Eligible to undergo laparoscopic or robotic LAR with or without a temporary diverting stoma, based on multidisciplinary tumor board consensus
- Able to understand and willing to sign a written informed consent form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto Western Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Kaiser Permanente Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Beth Israel Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| UC Irvine Hospital Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Florida Hospital Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Cleveland Clinic Florida Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| University of Massachusetts Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
| Lankenau Institute Coordinator of this site? Confirm its status | Wynnewood | United States | Unknown status |
Related publications
- Long-term Results of the North American Phase II Transanal Total Mesorectal Excision Multicenter Trial for Rectal Cancer.Ann Surg · 2026 · PMID 41773887
This page is information, not medical advice. Discuss any trial with your doctor.