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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%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My medical team agrees I can have minimally invasive rectal surgery.
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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.

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

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

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
852 Previous Clinical Trials
535,832 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for recruits to join this medical experiment?

"Per the information provided by clinicaltrials.gov, this medical trial is actively seeking participants to begin enrollment. The first post was made on April 21st 2017 and the most recent modification occurred on April 6th 2022."

Answered by AI

What is the current geographic scope of this clinical experiment?

"Patients can be recruited from Florida Hospital in Orlando, Mount Sinai Beth Israel in New york as well as Cleveland Clinic Florida located in Weston; these are only a few of the 13 other locations enrolling participants."

Answered by AI

To what extent is participation in this research project currently being undertaken?

"Verified. According to the information accessible on clinicaltrials.gov, this study is presently in need of volunteers and has been since April 21st 2017. The trial requires 100 patients from 13 distinct medical centres before it can be completed and was recently updated on April 6th 2022."

Answered by AI
~14 spots leftby Mar 2025