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NCT Number: NCT07651553

Transanal Total Mesorectal Excision vs Robotic Total Mesorectal Excision

TME remains standard treatment for rectal cancer. Both Robotic TME and taTME are innovative surgical techniques with potential advantages in low rectal cancer. To date, no clinical studies have directly compared the conversion and complication rates between taTME and RTME in this population. Therefore, the investigators propose to conduct a prospective, randomized, parallel-controlled clinical trial comparing taTME with RTME for low rectal cancer, aiming to provide high-level evidence for surgical decision-making and benefit more patients.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the sixth affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location status: Recruiting

About this study

Both RTME and taTME are innovative surgical techniques with potential advantages in low rectal cancer. Intraoperative conversion rate is a key safety metric. In low rectal cancer, changes in surgical approach not only affect resection outcomes but also sphincter preservation.To date, no clinical studies have directly compared the conversion and complication rates between taTME and RTME in this population. Therefore, the investigators propose to conduct a prospective, randomized, parallel-controlled clinical trial comparing taTME with RTME for low rectal cancer, aiming to provide high-level evidence for surgical decision-making and benefit more patients. The primary indicator in this study is intraoperative conversion rate. Definition in each group as follows: During transanal total mesorectal excision (taTME), if the procedure cannot be completed due to difficulty in transanal operation, conversion to open abdominal surgery is required to complete TME resection, allowing better operative access, organ preservation, and tumor clearance. During robot-assisted total mesorectal excision (rTME), if the transabdominal approach fails to achieve bowel transection or digestive reconstruction, conversion to transanal or open abdominal surgery is required to complete the procedure, ensuring operability, organ preservation, and tumor clearance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newly diagnosed patients aged 18-75 years. Pathologically confirmed adenocarcinoma (tubular, papillary, mucinous, or signet-ring). Tumor ≤7 cm from anal verge (MRI or DRE). Clinical stage T1-T3, N+, M0 (AJCC 8th ed.), suitable for sphincter-preserving TME. ASA score I-III.

ECOG performance status 0-1. Informed consent obtained.

  • Exclusion Criteria: Synchronous/metachronous colorectal cancers, local recurrence, or distant metastases. Bowel obstruction, perforation, bleeding requiring emergency surgery. Involvement of sphincter or adjacent organs requiring Inter-sphincter Resection (ISR). Poor preoperative anal function/incontinence. IBD or familial adenomatous polyposis (FAP).

Pregnancy or lactation. Severe psychiatric illness. Other malignancies within 5 years. Severe comorbidities or infections making surgery intolerable. Judged unsuitable by investigator.

Treatment and study plan

robotic surgery vs transanal total mesorectal excsion

Procedure

This study is designed to investigate the safety and superiority of transanal total mesorectal excision (taTME) in the treatment of rectal cancer compared with robot-assisted total mesorectal excision (rTME)

Primary outcomes

  1. Intraoperative Conversion Rate

    Time frame: at the end of operation

    During transanal total mesorectal excision (TaTME), if the procedure cannot be completed due to difficulty in transanal operation, conversion to open abdominal surgery is required to complete TME resection, allowing better operative access, organ preservation, and tumor clearance.

    During robot-assisted total mesorectal excision (rTME), if the transabdominal approach fails to achieve bowel transection or digestive reconstruction, conversion to transanal or open abdominal surgery is required to complete the procedure, ensuring operability, organ preservation, and tumor clearance.

Secondary outcomes

  1. 3-year disease-free survival (DFS)

    Time frame: three years after the operation

    3-Year DFS (Disease-Free Survival) refers to the proportion of patients who remain alive and free from any signs or recurrence of the disease for three years following surgical removal of the primary tumor.

  2. 3-Year OS

    Time frame: 3 years after the operation

    3-Year OS (Overall Survival) refers to the percentage of patients who remain alive for three years following a surgical procedure, regardless of the cause of death or the status of the disease. The survival time is typically calculated from the date of surgery to the date of death from any cause. Patients who are alive at the three-year mark-whether they are disease-free, have experienced a recurrence, or are receiving other treatments-are counted as survivors

  3. operative time

    Time frame: 1 day after the operation

    Operative time refers to the total duration measured from the initial surgical incision to the completion of wound closure. It typically includes all intraoperative procedures, such as dissection, resection (e.g., tumor removal), reconstruction, hemostasis, and placement of drains or implants, but excludes anesthesia induction, positioning, prepping, draping, and recovery room time

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Kang, MD

CONTACT

[email protected]

+8613602886833

Ling Shuang Luo, MD

CONTACT

[email protected]

+8613751756175

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Prospective, Randomized, Parallel-Controlled, Superiority Clinical Study Comparing Transanal Total Mesorectal Excision (taTME) and Robot-Assisted Total Mesorectal Excision (RTME) in the Treatment of Low Rectal Cancer

Acronym: TaLaR03

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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