taTME Surgery for Rectal Cancer
Trial Summary
What is the purpose of this trial?
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.
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 data supports the effectiveness of the treatment Transanal Total Mesorectal Excision (taTME) for rectal cancer?
Research shows that taTME is a promising new surgical method for rectal cancer, with studies indicating it may have advantages over traditional techniques in terms of safety and effectiveness. It has been shown to provide good surgical and short-term cancer outcomes, making it a valuable option for treating rectal cancer.12345
Is taTME surgery for rectal cancer generally safe for humans?
taTME surgery has raised safety concerns due to potential complications like urethral injury, CO2 embolism (air bubbles in the bloodstream), anastomotic leakage (leakage at the surgical connection), and pelvic infection. However, it is considered relatively safe and effective, especially for low rectal cancer, with a promising future if proper training and high-quality studies are conducted.678910
How is the treatment taTME for rectal cancer different from other treatments?
Transanal Total Mesorectal Excision (taTME) is a new surgical technique for rectal cancer that uses a 'bottom to up' approach, allowing surgeons to operate through the anus. This method aims to improve precision and outcomes compared to traditional laparoscopic surgery, especially for tumors in the lower rectum.13111213
Research Team
Patricia Sylla, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo laparoscopically-assisted Transanal Total Mesorectal Excision (taTME) with potential inclusion of intersphincteric resection for very low tumors.
Postoperative Care
Subjects are managed according to standard postoperative protocols with follow-up visits to monitor recovery and complications.
Follow-up
Participants are monitored for oncologic outcomes and functional results, with questionnaires administered at various intervals postoperatively.
Treatment Details
Interventions
- Transanal Total Mesorectal Excision (taTME)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Research Foundation of the American Society of Colon and Rectal Surgeons
Collaborator
Society of American Gastrointestinal and Endoscopic Surgeons
Collaborator