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Trial Title:
RATME vs LATME in Middle and Low Rectal Cancer
NCT ID:
NCT06105203
Condition:
Total Mesorectal Excision
Rectal Neoplasms
Robotic Surgical Procedures
Laparoscopy
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Robotic-assisted total mesorectal excision
Description:
TME will be performed with the assistance of robot in rectal cancer
Arm group label:
RATME
Intervention type:
Procedure
Intervention name:
laparoscopic-assisted total mesorectal excision
Description:
TME will be performed with the assistance of laparoscopy in rectal cancer
Arm group label:
LATME
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.
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 (TME) in rectal cancer, especially middle and low
rectal cancer with a narrow pelvis. Therefore, this trial investigates whether RATME has
technical advantages and increase intersphincteric resection rate compared with
laparoscopic-assisted TME (LATME) in middle and low rectal cancer.
This is a multicenter, superior, randomized controlled trial designed to compare RATME
and 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. In addition, certain measures will be conducted to ensure quality and safety,
including centralized photography review and semiannual assessment.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Contact:
Last name:
Yuchen Guo, Ph.D.
Phone:
+8613630598312
Email:
guoyuchen8688@live.com
Start date:
January 1, 2024
Completion date:
January 2031
Lead sponsor:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Collaborator:
Agency:
Jilin Provincial Tumor Hospital
Agency class:
Other
Collaborator:
Agency:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Dalian Medical University
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Harbin Medical University
Agency class:
Other
Source:
The First Hospital of Jilin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06105203
