Multicenter Phase II Study of Transanal TME (taTME)

NCT03144765 | Active Not Recruiting DMC

• 1 other identifier: GCO 16-2009
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 12

Brief 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

Rectal Cancer; Surgery

Keywords

taTME; Transanal; Rectal cancer; Colorectal; Total mesorectal excision; TME

Outcome Measures

Primary Outcomes (1)

• Quality of Mesorectal Excision

  Rate of complete and near-complete mesorectal excision achieved with taTME, based on standard pathologic assessment of TME specimens.

  30 days

Secondary Outcomes (10)

• Complete pathology assessment of TME specimens

  30 days

• 30-day perioperative complications

  30 days

• Long-term postoperative complications

  12 months

• Change in COREFO scores

  18 months

• Change in FIQLscores

  18 months

Study Arms (1)

taTME

EXPERIMENTAL

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

Procedure: Transanal Total Mesorectal Excision (taTME)

Interventions

Transanal Total Mesorectal Excision (taTME) PROCEDURE

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

Also known as: taTME

taTME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Prior history of rectal resection
• Prior history of colorectal cancer
• History of inflammatory bowel disease
• Uncontrolled concurrent illness
• Pregnancy
• Subjects who cannot read or understand English

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Society of American Gastrointestinal and Endoscopic Surgeons: collaborator
• Research Foundation of the American Society of Colon and Rectal Surgeons: collaborator

Study Sites (12)

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UC Irvine Hospital

Orange, California, 92868, United States

Location

Florida Hospital

Orlando, Florida, 32804, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01605, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Lankenau Institute

Wynnewood, Pennsylvania, 19096, United States

Location

Toronto Western Hospital

Toronto, Canada

Location

Related Publications (1)

• Sylla P, Sands D, Ricardo A, Bonaccorso A, Polydorides A, Berho M, Marks J, Maykel J, Alavi K, Zaghiyan K, Whiteford M, Mclemore E, Chadi S, Shawki SF, Steele S, Pigazzi A, Albert M, DeBeche-Adams T, Moshier E, Wexner SD. Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results. Surg Endosc. 2023 Dec;37(12):9483-9508. doi: 10.1007/s00464-023-10266-9. Epub 2023 Sep 12.

  PMID: 37700015 DERIVED

Related Links

• Study description on SAGES website

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Patricia Sylla, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: September 25, 2017
• Primary Completion: May 2, 2022
• Study Completion (Estimated): April 12, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); CA (1)