taTME Surgery for Rectal Cancer

Not currently recruiting at 12 trial locations

Overseen By Justin Maykel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Inflammatory bowel disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical method for individuals with resectable rectal cancer, known as transanal total mesorectal excision (taTME). The aim is to determine if this technique, which involves operating from the bottom up with camera assistance, matches the effectiveness of standard surgery. Researchers aim for less surgical trauma and better recovery while ensuring successful cancer removal. Suitable candidates have recently been diagnosed with rectal cancer near the anus and show no signs of cancer spread. As an unphased trial, this study allows patients to contribute to innovative surgical techniques that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for rectal cancer surgery?

Research has shown that transanal total mesorectal excision (taTME) is generally safe for treating rectal cancer. Studies have found taTME to be as safe and effective as other surgeries, such as laparoscopic TME. For example, one study reported a low local cancer recurrence rate of just 3.5% and found that urinary function remained stable over time. However, some patients experienced a decrease in sexual function after the surgery. Overall, evidence suggests that taTME is well-tolerated, though patients might face some side effects, particularly regarding sexual health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transanal Total Mesorectal Excision (taTME) for rectal cancer because it represents a novel surgical approach that could enhance precision and outcomes. Unlike the traditional abdominoperineal resection, taTME is performed transanally, which might provide better access to the tumor and allow for more accurate removal of cancerous tissues. This method could reduce the risk of damaging surrounding healthy tissues, potentially leading to fewer complications and faster recovery times. Additionally, taTME could improve the surgeon's ability to achieve clear margins, which is crucial for reducing the risk of cancer recurrence.

What evidence suggests that taTME is effective for rectal cancer?

Studies have shown that Transanal Total Mesorectal Excision (taTME), the procedure under study in this trial, is an effective and safe treatment for middle and low rectal cancers. Specifically, one study found a 89.4% survival rate for patients three years after undergoing taTME. Another study highlighted that taTME addresses the challenges of low rectal surgery and demonstrates positive outcomes. Research also suggests that taTME is as safe and effective as the traditional laparoscopic method for these cancers. Overall, early results indicate that taTME could be a promising option for those needing rectal cancer surgery. ^{2 3 4 6 7}

Who Is on the Research Team?

Patricia Sylla, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My medical team agrees I can have minimally invasive rectal surgery.

My cancer is at an early but high-risk or moderate stage without significant spread to nearby lymph nodes.

Exclusion Criteria

I have a history of inflammatory bowel disease.

It has been over 12 weeks since I finished my pre-surgery treatment.

My tumor has spread into the internal anal muscle, confirmed by MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopically-assisted Transanal Total Mesorectal Excision (taTME) with potential inclusion of intersphincteric resection for very low tumors.

Immediate surgical procedure

1 visit (in-person)

Postoperative Care

Subjects are managed according to standard postoperative protocols with follow-up visits to monitor recovery and complications.

30 days

Multiple visits (in-person)

Follow-up

Participants are monitored for oncologic outcomes and functional results, with questionnaires administered at various intervals postoperatively.

18 months

Regular visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Transanal Total Mesorectal Excision (taTME)

Trial Overview 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.

How Is the Trial Designed?

Group I: taTME Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Research Foundation of the American Society of Colon and Rectal Surgeons

Collaborator

Trials

2

Recruited

350+

Society of American Gastrointestinal and Endoscopic Surgeons

Collaborator

Trials

10

Recruited

660+

Published Research Related to This Trial

In a review of 179 cancer surgery trial reports, only 31.3% focused on morbidity assessment, highlighting a lack of emphasis on adverse event (AE) reporting in these studies.

Only 8.3% of studies provided detailed reporting of AEs by event and grade, indicating a significant need for improvement in how AEs are documented and defined in cancer surgery trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting adverse events in cancer surgery randomized trials: A systematic review of published trials in oesophago-gastric and gynecological cancer patients. Meghelli, L., Narducci, F., Mariette, C., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1533002825000830

Long-term Oncological Outcomes of Transanal Total ... 3-year survival outcomes were: Overall Survival 89.4%, Disease Free Survival 95.5%, Disease Specific Survival 85.5%, and Local recurrence 3.5%.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39145821/

Transanal total mesorectal excision: short- and long-term ... Conclusion: TaTME proves effective in addressing the anatomical and technical challenges of low rectal surgery and is associated with pleasing ...

3. nature.com nature.com/articles/s41598-023-44247-8

Transanal total mesorectal excision (TaTME) in rectal ... This study showed that the TaTME procedure is an effective and safe method for the minimally invasive treatment of middle and low rectal cancers.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2829541

Transanal vs Laparoscopic Total Mesorectal Excision and ... The TaLaR trial indicates that transanal TME is as safe and effective as laparoscopic TME for patients with mid-low rectal cancers, measured by ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0294510

Long-term efficacy of transanal local excision versus total ... The purpose of this meta-analysis is to compare the long-term efficacy of transanal local excision (TLE) versus total mesorectal excision ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38091943/

Long-term oncological outcomes of transanal versus ... In this study, taTME demonstrated comparable oncologic safety to laTME in patients with mid-low rectal cancer. Moreover, the results ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38869440/

Functional Outcomes After Transanal Total Mesorectal ... Urinary function was preserved while sexual function declined without improvement by 18 months post-taTME. Our results address patient ...