Status:
NOT_YET_RECRUITING
RATME Vs LATME in Middle and Low Rectal Cancer
Lead Sponsor:
The First Hospital of Jilin University
Collaborating Sponsors:
Jilin Provincial Tumor Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Conditions:
Total Mesorectal Excision
Rectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 midd...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
1026 Patients enrolled
Trial Details
Trial ID
NCT06105203
Start Date
November 1 2025
End Date
January 1 2031
Last Update
February 19 2025
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China, 130021