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Procedure

taTME Surgery for Rectal Cancer

N/A
Waitlist Available
Led By Patricia Sylla, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical stage cT1 (high-risk), T2, or T3, cN0, N1, N2 on staging pelvic MRI
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Must not have
History of inflammatory bowel disease
>12 weeks delay between completion of neoadjuvant CRT and planned study procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is a 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.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical surgical risks such as bleeding and infection; disturbances in sexual, urinary and defecatory function similar to other TME techniques; plus any specific complications related to the transanal approach.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is at an early but high-risk or moderate stage without significant spread to nearby lymph nodes.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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I have been newly diagnosed with rectal cancer.
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My recent colonoscopy showed no signs of additional colon cancer.
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My rectal cancer is within 10 cm of the anal opening.
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My CT scans show no signs of cancer spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of inflammatory bowel disease.
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It has been over 12 weeks since I finished my pre-surgery treatment.
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My tumor has spread into the internal anal muscle, confirmed by MRI.
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I have had surgery to remove part of my rectum.
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I have had colorectal cancer in the past.
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My MRI shows my cancer is at stage cT4.
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My rectal tumor causes severe symptoms.
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I experience loss of bowel control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quality of Mesorectal Excision
Secondary study objectives
3-year oncologic outcomes
30-day perioperative complications
Change in COREFO scores
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: taTMEExperimental Treatment1 Intervention
Enrolled subjects will undergo the study procedure, laparoscopically-assisted Transanal Total Mesorectal Excision (taTME).

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
903 Previous Clinical Trials
541,667 Total Patients Enrolled
Research Foundation of the American Society of Colon and Rectal SurgeonsOTHER
1 Previous Clinical Trials
250 Total Patients Enrolled
Society of American Gastrointestinal and Endoscopic SurgeonsOTHER
9 Previous Clinical Trials
562 Total Patients Enrolled

Media Library

Transanal Total Mesorectal Excision (taTME) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03144765 — N/A
Colorectal Cancer Research Study Groups: taTME
Colorectal Cancer Clinical Trial 2023: Transanal Total Mesorectal Excision (taTME) Highlights & Side Effects. Trial Name: NCT03144765 — N/A
Transanal Total Mesorectal Excision (taTME) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03144765 — N/A
~13 spots leftby Nov 2025
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