NCT06105203Not yet recruiting
RATME Vs LATME in Middle and Low Rectal Cancer
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.
Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1026 (estimated)
- First submitted
- 3 Sept 2023
- Start date
- 1 Nov 2025
- Primary completion date
- Jan 2028
- Lead sponsor
- The First Hospital of Jilin University
- Diseases
- Colorectal cancer
- NCT number
- NCT06105203
What you commit to
- Study type: Interventional
- Planned participants: 1026
- From 1 Nov 2025 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Refuse surgical treatment after randomization;
- Open surgery was performed for treatment after randomization;
Other illness
- multiple primary cancers;
- history of open surgery;
- Patients with rectal cancer who undergo endoscopic resection first and need subsequent transabdominal resection;
- Bordeaux type IV low rectal cancer;
Other
- no preoperative MR evaluation and inadequate evaluation of tumor stage;
- The preoperative pathological types are signet ring cell carcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma.
- Exit Criteria
- Patients request to withdraw from the study at any time during the entire study process after randomization
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.