RATME Vs LATME in Middle and Low Rectal Cancer

Launched by THE FIRST HOSPITAL OF JILIN UNIVERSITY · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different surgical methods for treating middle and low rectal cancer: Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME). The goal is to determine which method is better by comparing their outcomes, including how often patients need additional surgeries and their overall recovery. This study is for male patients who have been diagnosed with rectal cancer but do not have any spread of the disease to other parts of the body. To participate, patients should have tumors located at a certain depth and position in the rectum, as determined by imaging tests.

If you join this trial, you can expect to undergo one of the two surgical procedures, depending on which group you are assigned to. The trial will also monitor your recovery over the first 30 days after surgery and assess long-term outcomes, like survival and quality of life. It’s important to know that certain conditions, such as having multiple cancers or specific types of rectal cancer, may prevent you from participating. The trial is not yet recruiting participants, but it aims to gather valuable information that could improve treatment options for rectal cancer in the future.

Gender

ALL

Eligibility criteria

• 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