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Comparing two surgical methods for rectal cancer treatment

Transanal Versus Laparoscopic Total Mesorectal Excision for Mid and Low Rectal Cancer (TaLaR): a Multicentre Randomised Clinical Trial

Not applicable Interventional Sun Yat-sen University · NCT02966483

This study is testing whether a new surgical method for rectal cancer called TaTME works better than the standard laparoscopic method to see if it helps patients have better outcomes.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1114 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorSun Yat-sen University Academic / other
Locations16 sites (Beijing, Beijing Municipality and 15 other locations)
Trial IDNCT02966483 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of transanal total mesorectal excision (TaTME) compared to laparoscopic total mesorectal excision (LpTME) for patients with rectal cancer. It is a prospective, multi-center, randomized, open-label trial designed to assess resection quality and long-term survival outcomes. The study aims to determine if TaTME can provide better access and oncological results for mid and low rectal cancers, particularly in challenging cases. Participants will be randomly assigned to one of the two surgical approaches, and data will be collected using a central electronic system.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically proven rectal adenocarcinoma located below the peritoneal reflection and amenable to curative surgery.

Not a fit: Patients with T4b tumors invading adjacent organs or those requiring a Miles procedure will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and long-term survival for patients with rectal cancer.

How similar studies have performed: Previous smaller studies have shown promising results for TaTME, but this study aims to validate its effectiveness in a larger, randomized setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

histologically proven rectal adenocarcinoma;

tumor located below the level of peritoneal reflection ;

diagnosis of rectal cancer amenable to curative surgery;

no evidence of distant metastases;

preoperative tumor stage within III;

no threaten mesorectal fascia (MRF)after neoadjuvant therapy;

no contraindication to laparoscopic surgery;

without history of other malignancies;

Written informed consent

Exclusion Criteria:

could not perform sphincter preservation surgery (requiring a Mile's procedure);

T4b tumor invading adjacent organs;

T1 tumors that can be locally resected

should take neoadjuvant therapy but refuse it;

recurrent cancer;

concurrent or previous diagnosis of invasive cancer within 5 years;

emergent surgery with intestinal obstruction or perforation;

history of colorectal surgery;

fecal incontinence;

history of inflammatory bowel disease;

with contraindications to general anaesthesia(ASA class 4 or 5);

pregnant or breast-feeding;

history of mental disorder

Where this trial is running

Beijing, Beijing Municipality and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rectal Neoplasms MalignantSurgeryRectal cancerLaparoscopic surgeryTotal mesorectal excisionTransanalMulticentre randomised clinical trial
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.