RATME Vs LATME in Middle and Low Rectal Cancer

NCT06105203 · tracked via the Priya Life Science China tracker

Sponsor

The First Hospital of Jilin University

Phase

Not applicable

Started

2025-11-01

Last updated

2025-02-19

Condition(s) studied

Total Mesorectal ExcisionRectal NeoplasmsRobotic Surgical ProceduresLaparoscopy

Investigational drug(s) / intervention(s)

Robotic-assisted total mesorectal excisionlaparoscopic-assisted total mesorectal excision

Robotic-assisted total mesorectal excision: TME will be performed with the assistance of robot in rectal cancer

laparoscopic-assisted total mesorectal excision: TME will be performed with the assistance of laparoscopy in rectal cancer

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. male patients diagnosed with rectal cancer by pathological biopsy; 2. abdominal contrast-enhanced and chest computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) revealed no distal metastasis; 3. 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; 4. 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; 5. The patient underwent laparoscopic assisted TME surgery or robotic assisted TME surgery. Exclusion Criteria: 1. multiple primary cancers; 2. history of open surgery; 3. no preoperative MR evaluation and inadequate evaluation of tumor stage; 4. Patients with rectal cancer who undergo endoscopic resection first and need subsequent transabdominal resection; 5. Pregnant or patients with concomitant inflammatory bowel disease; 6. Patients with preoperative complete bowel obstruction or requiring emergency surgery; 7. Preoperative evaluation indicates that patient may require combined organ resection; 8. Recently receiving treatment for other malignant tumors; 9. Bordeaux type IV low rectal cancer; 10. The preoperative pathological types are signet ring cell carcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma. Exit Criteria 1. Refuse surgical treatment after randomization; 2. Open surgery was performed for treatment after randomization; 3. Patients request to withdraw from the study at any time during the entire study process after randomization

Primary outcome measure(s)

intersphincteric resection (ISR) — 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

Trial sites (1)

Facility	City	Region	Status
The First Hospital of Jilin University	Changchun	Jilin

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06105203 on ClinicalTrials.gov ↗ ← All trials in China