NCT07376980Enrolling by invitation
The SMART Trial: Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer
Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer: The SMART Trial (Single-Modified Anastomosis for Rectal Cancer Surgery Technique), A Multicenter Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- Dec 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Korea University Anam Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07376980
What you commit to
- Study type: Interventional
- Planned participants: 450
- From Dec 2025 to the primary completion date, Dec 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent, or recent treatment for colorectal or other malignancies within the past five years
Other illness
- Who have significant comorbidities or history of abdominal surgeries that would preclude a minimally invasive approach
- Bowel obstruction for perforation requiring emergency surgey
- Presence of inflammatory bowel diseases
- Hereditary colorectal cancer syndrome
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.