Multi-Technology Integrated Total Mesorectal Excision Versus Conventional Total Mesorectal Excisi… (NCT06613399) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multi-Technology Integrated Total Mesorectal Excision Versus Conventional Total Mesorectal Excision for the Treatment of Middle and Distal Rectal Cancer.
324 participantsStarted 2025-01-01
Plain-language summary
A multicenter, prospective, randomized, controlled clinical trial of multi-technology integration total mesorectal excision (MTI-TME) versus conventional total mesorectal excision (C-TME) for the treatment of middle and distal rectal cancer
Who can participate
Age range
18 Years – 75 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
. Participants must be aged 18 to 75.
. Histopathological examination of the preoperative biopsy confirms adenocarcinoma.
. Preoperative MRI shows the tumor\'s lower margin is below the umbilical ligament.
. High-resolution CT and MRI do not indicate suspicious distant metastasis.
. Participants\' general condition is acceptable, with an ASA score of ≤3 before surgery.
. Participants must sign an informed consent form.
Exclusion criteria
. Developing other malignant tumors within 5 years;
. Multiple primary colorectal tumors;
. Pregnant or lactating women;
. Patients with severe mental disorders;
. Severe intestinal diseases;
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.
What they're measuring
1
anastomotic leakage rate
Timeframe: 1 year
Trial details
NCT IDNCT06613399
SponsorThe First Affiliated Hospital with Nanjing Medical University