RATME Vs LATME in Middle and Low Rectal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Hospital of Jilin University
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Robotic-assisted total mesorectal excision
- laparoscopic-assisted total mesorectal excision
Treatment groups
1,026 Participants
are divided into 2 treatment groupsSponsors and collaborators
The First Hospital of Jilin University
Lead sponsor
Jilin Provincial Tumor Hospital
Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborator
The Second Affiliated Hospital of Dalian Medical University
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
Source ClinicalTrials.gov