The SMART Trial: Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer
Enrolling by invitation · Not applicable
Conditions studied: Rectal Neoplasms, Rectal Neoplasms Malignant, Rectal Cancer, Rectal Cancer Surgery
In brief
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
Key facts
- Study ID
- NCT07376980
- Run by
- Korea University Anam Hospital
- People needed
- 450
- Starts
- 2025-12-20
- Expected to finish
- 2030-12-30
- Last updated by the study team
- 2026-01-29
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- St. Vincent's Hospital — Suwon, Gyeonggi-do, South Korea
- Kyungpook National University Chilgok Hospital — Daegu, Gyeongsangbuk-do, South Korea
- Kyung Hee University Hospital — Seoul, South Korea
- Korea University Anam Hospital — Seoul, South Korea
- Seoul National University Hospital — Seoul, South Korea
- Severance Hospital — Seoul, South Korea
Full record on ClinicalTrials.gov
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