The SMART Trial: Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Modified single-stapled anastomosis technique: This intervention applies a modified single-stapled anastomosis specifically to low anterior resection (LAR), where the technique has not been previously evaluated in a randomized controlled trial. Although similar concepts have been explored in anterior resection, their application in LAR is technically more challenging due to the deeper pelvic working space and more limited access to the rectal stump. In earlier studies, approximation of the linear staple line was performed through a Pfannelstein incision or mini-laparotomy incision during specimen extraction. In contrast, this trial utilizes a fully intracorporeal approach.
Study 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
Eligibility
Primary outcome measure(s)
- Anastomotic leakage — within 30 days after surgery
Anastomotic leakage will be assessed within 30 days after surgery using clinical evaluation and routine abdominopelvic computed tomography (APCT). Leakage is defined as any defect in the anastomosis that results in communication between the inside of the bowel and the surrounding tissue. Diagnostic criteria include clinical symptoms (such as fever, abdominal pain, or drainage contents), abnormal laboratory findings, or radiologic evidence of leakage on APCT. All leaks will be classified according to the grading system. * Grade A: Leakage requiring no active therapeutic intervention. * Grade B: Leakage requiring non-surgical management, such as antibiotics or percutaneous drainage. * Grade C: Leakage requiring reoperation. Routine postoperative CT for all participants ensures consistent and standardized detection of both symptomatic and asymptomatic leaks.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| St. Vincent's Hospital | Suwon | Gyeonggi-do | |
| Kyungpook National University Chilgok Hospital | Daegu | Gyeongsangbuk-do | |
| 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 |
More Korea University Anam Hospital trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07376980 on ClinicalTrials.gov ↗ ← All trials in South Korea