The SMART Trial: Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Rese… (NCT07376980) | Clinical Trial Compass
By InvitationNot Applicable
The SMART Trial: Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer
South Korea450 participantsStarted 2025-12-20
Plain-language summary
The goal of this clinical trial is to learn whether a modified single-stapled anastomosis (MST) can reduce anastomotic leakage compared with the conventional double-stapled technique (DST) in adult patients undergoing laparoscopic or robotic low anterior resection for rectal cancer.
The main questions it aims to answer are:
* Does MST lower the incidence of anastomotic leakage after rectal cancer surgery?
* Does MST improve short-term surgical outcomes compared with DST?
Researchers will compare the MST group with the DST group to see if MST leads to fewer anastomotic leaks and safer postoperative recovery.
Participants will:
Receive either MST or DST during minimally invasive rectal cancer surgery Undergo routine postoperative CT scans within one month after surgery to check for symptomatic or asymptomatic anastomotic leakage Attend scheduled follow-up visits and standard postoperative assessments as part of routine rectal cancer care
Who can participate
Age range
19 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:
* Adult patients with rectal cancer who are scheduled to undergo laparoscopic or robotic low anterior resection
* histologically confirmed rectal adenocarcinoma located within 15cm from anal verge.
* ECOG performance status of 0 to 2
* Any clinical stage
Exclusion Criteria:
* Who have significant comorbidities or history of abdominal surgeries that would preclude a minimally invasive approach
* Bowel obstruction for perforation requiring emergency surgey
* Concurrent, or recent treatment for colorectal or other malignancies within the past five years
* Presence of inflammatory bowel diseases
* Hereditary colorectal cancer syndrome
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.