Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorect… (NCT04230772) | Clinical Trial Compass
UnknownNot Applicable
Clinical Outcomes of NOSES Versus Traditional Robotic-assisted Surgery for Patients With Colorectal Cancer
China550 participantsStarted 2021-02-01
Plain-language summary
In this study, the investigators will compare the clinical outcomes of the natural orifice specimen extraction surgery versus traditional robotic-assisted surgery in the treatment of colorectal cancer.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 and ≤ 80 years;
✓. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
✓. Histological or cytological confirmation of colorectal adenocarcinoma;
✓. High rectal and sigmoid cancer with the lower margin of the tumor greater than 10 cm from the anal dentate line;
✓. T1-3N0M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition, Transvaginal NOSES procedure w specimen with a circumferential diameter of \<5 cm;
✓. Preoperative examination did not suggest distant metastasis, implantation or invasion of adjacent organs;
✓. Cardiopulmonary liver and kidney function can withstand surgery;
✓. Written informed consent for participation in the trial.
Exclusion criteria
✕. Not suitable for robot laparoscopic surgery;
✕. The tumor is too large to be pulled out through the anus or vagina;
✕. Simultaneous multiple primary cancer;
✕. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by primary cancer