The SMART Trial: Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer

Sponsor
Korea University Anam Hospital
Study ID
NCT07376980
Status
Enrolling By Invitation

Conditions

  • Rectal Cancer
  • Rectal Cancer Surgery
  • Rectal Neoplasms
  • Rectal Neoplasms Malignant

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modified single-stapled anastomosis technique — PROCEDURE
    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 Details

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 Dates

First listed
Jan 29, 2026
Start date
Dec 20, 2025
Status verified
Jan 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2030

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Modified single-stapled anastomosis technique
    Participants assigned to this arm will undergo minimally invasive low anterior resection using the modified single-stapled technique. After rectal resection, the two ends of the linear staple line of stump are approximated toward the center using a barbed suture. The circular stapler spike is introduced through the center of the staple line to ensure complete resection of the linear staple line, eliminating staple-line intersections. The reaminder of the procedure, including total mesorectal excision, follows standard oncologic principles.
  • No Intervention: Double-stapled anastomosis technique
    Participants assigned to this arm will undergo minimally invasive low anterior resection using the conventional double-stapled technique. The rectum is transected with linear stapler, followed by transanal introduction of a circular stapler to create an end-to-end anastomosis. The procedure represents current standard practice for low anterior resection in rectal cancer.

Primary Outcome Measure

Anastomotic leakage [ Time Frame: within 30 days after surgery ]

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