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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.