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NCT06105203

RATME Vs LATME in Middle and Low Rectal Cancer

Sponsor: The First Hospital of Jilin University

View on ClinicalTrials.gov

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.

Official 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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1026

Start Date

2025-11-01

Completion Date

2031-01

Last Updated

2025-02-19

Healthy Volunteers

Conditions

Total Mesorectal Excision Rectal Neoplasms Robotic Surgical Procedures Laparoscopy

Interventions

PROCEDURE

Robotic-assisted total mesorectal excision

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

PROCEDURE

laparoscopic-assisted total mesorectal excision

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

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

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China