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The SMART Trial: Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer
Sponsor: Korea University Anam Hospital
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
Official title: 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
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2025-12-20
Completion Date
2030-12-30
Last Updated
2026-01-29
Healthy Volunteers
No
Interventions
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.
Locations (6)
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