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NCT Number: NCT06105203

RATME Vs LATME in Middle and Low Rectal Cancer

This is a multicenter, superior, randomized controlled trial designed to compare Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME) for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Robotic-assisted total mesorectal excision (RATME) has been gradually applied by colorectal surgeons. Most surgeons consider RATME a safe method and believe it can facilitate total mesorectal excision (TME) in rectal cancer, especially middle and low rectal cancer with a narrow pelvis. Therefore, this trial investigates whether RATME has technical advantages and increase intersphincteric resection rate compared with laparoscopic-assisted TME (LATME) in middle and low rectal cancer.

This is a multicenter, superior, randomized controlled trial designed to compare RATME and LATME for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measures will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male patients diagnosed with rectal cancer by pathological biopsy;
  • abdominal contrast-enhanced and chest computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) revealed no distal metastasis;
  • Preoperative rectal magnetic resistance (MR) evaluation showed that the tumor was located at or below the peritoneal reflux plane, and at least 1cm above the anal sphincter groove, and did not invade the external anal sphincter;
  • Tumors located above the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-3, cN0-1, M0, and MRF (-); The tumors located below the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-2, cN0-1, M0, and MRF (-). After neoadjuvant treatment, the tumor above the hiatus of levator ani muscle is ycT3NxM0 or below; The tumor below the hiatus of levator ani muscle is ycT2NxM0;
  • The patient underwent laparoscopic assisted TME surgery or robotic assisted TME surgery.

Exclusion criteria

  • multiple primary cancers;
  • history of open surgery;
  • no preoperative MR evaluation and inadequate evaluation of tumor stage;
  • Patients with rectal cancer who undergo endoscopic resection first and need subsequent transabdominal resection;
  • Pregnant or patients with concomitant inflammatory bowel disease;
  • Patients with preoperative complete bowel obstruction or requiring emergency surgery;
  • Preoperative evaluation indicates that patient may require combined organ resection;
  • Recently receiving treatment for other malignant tumors;
  • Bordeaux type IV low rectal cancer;
  • The preoperative pathological types are signet ring cell carcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma.

Exit Criteria

  • Refuse surgical treatment after randomization;
  • Open surgery was performed for treatment after randomization;
  • Patients request to withdraw from the study at any time during the entire study process after randomization

Treatment and study plan

Robotic-assisted total mesorectal excision

Procedure

TME will be performed with the assistance of robot in rectal cancer

laparoscopic-assisted total mesorectal excision

Procedure

TME will be performed with the assistance of laparoscopy in rectal cancer

Primary outcomes

  1. intersphincteric resection (ISR)

    Time frame: during the operation

    The primary outcome is the incidence of ISR. ISR is defined according to the definition by a Japanese study group. When the distal resection margin is from dentate line to the intersphincteric groove, ISR will be recorded.The distal resection line of the internal anal sphincter was at the intersphincteric groove in total ISR, between the dentate line and the intersphincteric groove in subtotal ISR and at the dentate line in partial ISR

Secondary outcomes

  1. coloanal anastomosis (CAA)

    Time frame: during the operation

    CAA was defined as the anastomosis of distal colon and surgical anal canal. In CAA anastomosis, the distal resection margin is below the upper level of the levator ani muscle. Conversion to open was defined as an abdominal incision larger than necessary for specimen retrieval.

  2. conversion to open

    Time frame: during the operation

    Conversion to open surgery was defined as an abdominal incision larger than necessary for specimen retrieval extraction.

  3. conversion to transanal TME (TaTME)

    Time frame: during the operation

    Conversion to TaTME was defined as TME that cannot be finished via transabdominal approach, and have to be finished by transanal approach with the help of imaging system and endoscopic instruments. It should be noted that if TME was completely done via transabdominal approach, simply dissecting the internal sphincter and intersphincteric space or finish the coloanal anastomosis via transanal approach were not classified as TaTME

  4. 30-day postoperative morbidity

    Time frame: within 30 days after operation

    The 30-day morbidity is defined as intraoperative adverse events and postoperative complications within 30 days. The intraoperative adverse events include intraoperative bleeding (>200 ml), pelvic vascular and nerve injury, vascular injury in other parts, digestive tract injury, ureteral injury, and anastomotic defect. Furthermore, the 30-day postoperative complications are evaluated according to Clavien-Dindo classification

  5. 30-day postoperative mortality

    Time frame: within 30 days after operation

    The 30-day mortality is defined as death within 30 day after operation

  6. 3-year disease-free survival (DFS)

    Time frame: 3 years after operation

    DFS is defined as the time from randomization to the discovery of local recurrence, distant metastasis, or death of the tumor

  7. 3-year local recurrence rate (LR)

    Time frame: 3 years after operation

    LR is defined as tumor recurrence (evaluated by positron emission tomography, computed tomography, or magnetic resistance) that occurs in the pelvic cavity, perineal area, root of inferior mesenteric artery, descending colon, and sigmoid mesenteric area, and is confirmed through pathological biopsy or reoperation.

  8. 3-year overall survival (OS)

    Time frame: 3 years after operation

    OS is defined as the time from randomization to death due to any cause.

  9. distance to distal resection margin (DRM)

    Time frame: within 30 days after operation

    The distance to the DRM is defined as the shortest length between the tumor and the DRM. DRM positivity is defined as a distal margin within 1 mm of the tumor.

  10. distance to circumferential resection margin (CRM)

    Time frame: within 30 days after operation

    The distance to the CRM is defined as the shortest length between the tumor and the CRM. CRM positivity is defined as tumor cells within 1 mm from the CRM by microscopy

  11. 3-year urinary function

    Time frame: 3 years after operation

    Urinary function will be evaluated by International consultation on incontinence questionnaire short form (ICIQ-SF). The patients will be asked to complete ICIQ-SF every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.

  12. The proportion of patients receiving abdominoperineal resection

    Time frame: during the operation

    the proportion of patients receiving abdominoperineal resection

  13. 3-year quality of life

    Time frame: 3 years after operation

    Quality of life will be evaluated by EORTC quality of life questionnaire-core 30 (QLQ-C30) form. The patients will be asked to complete QLQ-C30 every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.

  14. 3-year sexual function

    Time frame: 3 years after operation

    Sexual function of male will be evaluated by International Index of Erectile Function (IIEF-5). Sexual function of female will be evaluated by Female Sexual Function Index (FSFI). Evaluation will be performed every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.

  15. 3-year defecation function

    Time frame: 3 years after operation

    Defecation function will be evaluated by low anterior resection syndrome (LARS) form. The patients will be asked to complete LARS form every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.

Study contacts

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

Yuchen Guo, Ph.D.

CONTACT

[email protected]

+8613630598312

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Collaborators

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Jilin Provincial Tumor Hospital
  • The Second Affiliated Hospital of Dalian Medical University
  • The Second Affiliated Hospital of Harbin Medical University

Registry information

Official study title

A Multicenter Randomized Clinical Trial to Assess the Advantages of Robotic Total Mesorectal Excision in Preserving External Sphincter in Patients with Middle and Low Rectal Cancer.

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Oct 27, 2023
Registry last updated
Feb 19, 2025

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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